{ "resourceType": "StructureDefinition", "id": "device-registration", "url": "https://udi.anvisa.gov.br/fhir/StructureDefinition/UdiData", "version": "1.0.0", "name": "UdiData", "title": "UDI Data", "status": "draft", "description": "Representation of a device record instance in the UDI system", "fhirVersion": "5.0.0", "kind": "resource", "abstract": false, "type": "DeviceDefinition", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition", "derivation": "constraint", "snapshot": { "element": [ { "id": "DeviceDefinition", "path": "DeviceDefinition", "short": "Representation of a device registration instance in the UDI system", "definition": "The characteristics, operational status and capabilities of a medical-related component of a medical device.", "comment": "For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition", "min": 0, "max": "*" }, "constraint": [ { "key": "dom-2", "severity": "error", "human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources", "expression": "contained.contained.empty()", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-4", "severity": "error", "human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated", "expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-3", "severity": "error", "human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource", "expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice", "valueBoolean": true }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation", "valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." } ], "key": "dom-6", "severity": "warning", "human": "A resource should have narrative for robust management", "expression": "text.`div`.exists()", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-5", "severity": "error", "human": "If a resource is contained in another resource, it SHALL NOT have a security label", "expression": "contained.meta.security.empty()", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "Entity. Role, or Act" }, { "identity": "rim", "map": "Entity, Role, or Act" }, { "identity": "w5", "map": "administrative.device" } ] }, { "id": "DeviceDefinition.id", "path": "DeviceDefinition.id", "short": "Logical id of this artifact", "definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.", "comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.", "min": 0, "max": "1", "base": { "path": "Resource.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ], "code": "id" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.meta", "path": "DeviceDefinition.meta", "short": "Metadata about the resource", "definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.", "min": 0, "max": "1", "base": { "path": "Resource.meta", "min": 0, "max": "1" }, "type": [ { "code": "Meta" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.implicitRules", "path": "DeviceDefinition.implicitRules", "short": "A set of rules under which this content was created", "definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.", "comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.", "min": 0, "max": "1", "base": { "path": "Resource.implicitRules", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": true, "isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.language", "path": "DeviceDefinition.language", "short": "Language of the resource content", "definition": "The base language in which the resource is written.", "comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).", "min": 0, "max": "1", "base": { "path": "Resource.language", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Language" } ], "strength": "required", "description": "IETF language tag for a human language", "valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0", "additional": [ { "purpose": "starter", "valueSet": "http://hl7.org/fhir/ValueSet/languages" } ] }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.text", "path": "DeviceDefinition.text", "short": "Text summary of the resource, for human interpretation", "definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.", "comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.", "alias": [ "narrative", "html", "xhtml", "display" ], "min": 0, "max": "1", "base": { "path": "DomainResource.text", "min": 0, "max": "1" }, "type": [ { "code": "Narrative" } ], "condition": [ "dom-6" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" }, { "identity": "rim", "map": "Act.text?" } ] }, { "id": "DeviceDefinition.contained", "path": "DeviceDefinition.contained", "short": "Contained, inline Resources", "definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.", "comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.", "alias": [ "inline resources", "anonymous resources", "contained resources" ], "min": 0, "max": "*", "base": { "path": "DomainResource.contained", "min": 0, "max": "*" }, "type": [ { "code": "Resource" } ], "condition": [ "dom-2", "dom-4", "dom-3", "dom-5" ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "Entity. Role, or Act" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.extension", "path": "DeviceDefinition.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 1, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.extension:refurbisherReprocessingCompany", "path": "DeviceDefinition.extension", "sliceName": "refurbisherReprocessingCompany", "short": "Refurbisher/Reprocessing Company's information", "definition": "Optional Extension Element - found in all resources.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/RefurbisherReprocessingCompany" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.extension:legalManufacturer", "path": "DeviceDefinition.extension", "sliceName": "legalManufacturer", "short": "Legal Manufacturer's information", "definition": "Optional Extension Element - found in all resources.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 1, "max": "1", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/LegalManufacturer" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.modifierExtension", "path": "DeviceDefinition.modifierExtension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Extensions that cannot be ignored", "definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "DomainResource.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mustSupport": false, "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.description", "path": "DeviceDefinition.description", "short": "Additional information to describe the device", "definition": "Additional information to describe the device.", "comment": "Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.description", "min": 0, "max": "1" }, "type": [ { "code": "markdown" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.identifier", "path": "DeviceDefinition.identifier", "short": "Instance identifier", "definition": "Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.", "comment": "The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.identifier", "min": 0, "max": "*" }, "type": [ { "code": "Identifier" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ident-1", "severity": "warning", "human": "Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason", "expression": "value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Identifier" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "identity": "w5", "map": "FiveWs.identifier" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "Unique Device Identifier (UDI) Barcode string", "definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.", "min": 1, "max": "2", "base": { "path": "DeviceDefinition.udiDeviceIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.id", "path": "DeviceDefinition.udiDeviceIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.extension", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "short": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier", "definition": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.issuer", "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "short": "The organization that assigns the identifier algorithm", "definition": "The organization that assigns the identifier algorithm.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "short": "The jurisdiction to which the deviceIdentifier applies", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "UdiDeviceIdentifierMarketDistribution" } ], "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "short": "Indicates whether and when the device is available on the market", "definition": "Indicates where and when the device is available on the market.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "short": "Begin and end dates for the commercial distribution of the device", "definition": "Begin and end dates for the commercial distribution of the device.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "min": 1, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "short": "National state or territory where the device is commercialized", "definition": "National state or territory to which the marketDistribution recers, typically where the device is commercialized.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier", "sliceName": "udiDeviceIdentifier", "short": "UDI-DI of the device", "definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.id", "path": "DeviceDefinition.udiDeviceIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension:repurposingType", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "sliceName": "repurposingType", "short": "Identification of the type of repurposing applied to this UDI-DI's device", "definition": "Optional Extension Element - found in all resources.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/RepurposingType" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.deviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "short": "The UDI-DI number associated with the device", "definition": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 25, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.issuer", "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "short": "The UDI-DI's issuer", "definition": "The organization that assigns the identifier algorithm.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.jurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "UdiDeviceIdentifierMarketDistribution" } ], "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "short": "Indicates whether and when the device is available on the market", "definition": "Indicates where and when the device is available on the market.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.id", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.extension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "short": "Begin and end dates for the commercial distribution of the device", "definition": "Begin and end dates for the commercial distribution of the device.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "min": 1, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.id", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.extension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.start", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start", "short": "Specify the date from which the company wishes the data to be made public. If left blank, the system will consider the submission date to publish the submitted information", "definition": "The start of the period. The boundary is inclusive.", "comment": "If the low element is missing, the meaning is that the low boundary is not known.", "min": 0, "max": "1", "base": { "path": "Period.start", "min": 0, "max": "1" }, "type": [ { "code": "dateTime" } ], "condition": [ "per-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR.1" }, { "identity": "rim", "map": "./low" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.end", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end", "short": "Specify the date when the product will be discontinued, no longer offered on the market", "definition": "The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.", "comment": "The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.", "min": 0, "max": "1", "base": { "path": "Period.end", "min": 0, "max": "1" }, "type": [ { "code": "dateTime" } ], "meaningWhenMissing": "If the end of the period is missing, it means that the period is ongoing", "condition": [ "per-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR.2" }, { "identity": "rim", "map": "./high" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.subJurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "short": "National jurisdiction. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field", "definition": "National state or territory to which the marketDistribution recers, typically where the device is commercialized.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal", "path": "DeviceDefinition.udiDeviceIdentifier", "sliceName": "udiDeviceIdentifierOriginal", "short": "UDI-DI of the original device who is being refurbished/reprocessed", "definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.id", "path": "DeviceDefinition.udiDeviceIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.extension", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.deviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "short": "The UDI-DI number associated with the device", "definition": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 25, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.issuer", "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "short": "The UDI-DI's issuer", "definition": "The organization that assigns the identifier algorithm.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.jurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "UdiDeviceIdentifierMarketDistribution" } ], "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "short": "Indicates whether and when the device is available on the market", "definition": "Indicates where and when the device is available on the market.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution.id", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution.extension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution.modifierExtension", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution.marketPeriod", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "short": "Begin and end dates for the commercial distribution of the device", "definition": "Begin and end dates for the commercial distribution of the device.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod", "min": 1, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" } ] }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution.subJurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "short": "National state or territory where the device is commercialized", "definition": "National state or territory to which the marketDistribution recers, typically where the device is commercialized.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier", "path": "DeviceDefinition.regulatoryIdentifier", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "Regulatory identifier(s) associated with this device", "definition": "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.", "comment": "This should not be used for regulatory authorization numbers which are to be captured elsewhere.", "min": 1, "max": "2", "base": { "path": "DeviceDefinition.regulatoryIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.id", "path": "DeviceDefinition.regulatoryIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.extension", "path": "DeviceDefinition.regulatoryIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.modifierExtension", "path": "DeviceDefinition.regulatoryIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.type", "path": "DeviceDefinition.regulatoryIdentifier.type", "short": "basic | master | license", "definition": "The type of identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceRegulatoryIdentifierType" } ], "strength": "required", "description": "Device regulatory identifier type.", "valueSet": "http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "short": "The identifier itself", "definition": "The identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.issuer", "path": "DeviceDefinition.regulatoryIdentifier.issuer", "short": "The organization that issued this identifier", "definition": "The organization that issued this identifier.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "short": "The jurisdiction to which the deviceIdentifier applies", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber", "path": "DeviceDefinition.regulatoryIdentifier", "sliceName": "premarketAuthorizationNumber", "short": "The Premarket Authorization Number seen in the Anvisa's product registration", "definition": "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.", "comment": "This should not be used for regulatory authorization numbers which are to be captured elsewhere.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.id", "path": "DeviceDefinition.regulatoryIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.extension", "path": "DeviceDefinition.regulatoryIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.modifierExtension", "path": "DeviceDefinition.regulatoryIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.type", "path": "DeviceDefinition.regulatoryIdentifier.type", "short": "license | unit-of-use", "definition": "The type of identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "license", "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceRegulatoryIdentifierType" } ], "strength": "required", "description": "Device regulatory identifier type.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.deviceIdentifier", "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "short": "The identifier itself", "definition": "The identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 11, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.issuer", "path": "DeviceDefinition.regulatoryIdentifier.issuer", "short": "The organization that issued this identifier", "definition": "The organization that issued this identifier.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.jurisdiction", "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "short": "The jurisdiction to which the deviceIdentifier applies", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber", "path": "DeviceDefinition.regulatoryIdentifier", "sliceName": "unitOfUseNumber", "short": "The Unit of Use (UOU) DI Number - Identifier assigned to the individual medical device where UDI is not labeled at the unit of use level", "definition": "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.", "comment": "This should not be used for regulatory authorization numbers which are to be captured elsewhere.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.id", "path": "DeviceDefinition.regulatoryIdentifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.extension", "path": "DeviceDefinition.regulatoryIdentifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.modifierExtension", "path": "DeviceDefinition.regulatoryIdentifier.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.type", "path": "DeviceDefinition.regulatoryIdentifier.type", "short": "license | unit-of-use", "definition": "The type of identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "unit-of-use", "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceRegulatoryIdentifierType" } ], "strength": "required", "description": "Device regulatory identifier type.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.deviceIdentifier", "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "short": "The identifier itself", "definition": "The identifier itself.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "patternString": "[0-9]+", "maxLength": 23, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.issuer", "path": "DeviceDefinition.regulatoryIdentifier.issuer", "short": "The organization that issued this identifier", "definition": "The organization that issued this identifier.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.issuer", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.jurisdiction", "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "short": "The jurisdiction to which the deviceIdentifier applies", "definition": "The jurisdiction to which the deviceIdentifier applies.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.regulatoryIdentifier.jurisdiction", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.partNumber", "path": "DeviceDefinition.partNumber", "short": "Catalog Number", "definition": "The part number or catalog number of the device.", "comment": "Alphanumeric Maximum 20.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.partNumber", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 80, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".playedRole[typeCode=MANU].id" } ] }, { "id": "DeviceDefinition.manufacturer", "path": "DeviceDefinition.manufacturer", "short": "Name of device manufacturer", "definition": "A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.manufacturer", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".playedRole[typeCode=MANU].scoper.name" } ] }, { "id": "DeviceDefinition.deviceName", "path": "DeviceDefinition.deviceName", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "The name or names of the device as given by the manufacturer", "definition": "The name or names of the device as given by the manufacturer.", "min": 2, "max": "2", "base": { "path": "DeviceDefinition.deviceName", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName.id", "path": "DeviceDefinition.deviceName.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName.extension", "path": "DeviceDefinition.deviceName.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName.modifierExtension", "path": "DeviceDefinition.deviceName.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName.name", "path": "DeviceDefinition.deviceName.name", "short": "A name that is used to refer to the device", "definition": "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "alias": [ "Σ" ], "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.name", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName.type", "path": "DeviceDefinition.deviceName.type", "short": "registered-name | user-friendly-name | patient-reported-name", "definition": "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceNameType" } ], "strength": "required", "description": "The type of name the device is referred by.", "valueSet": "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".playedRole[typeCode=MANU].code" } ] }, { "id": "DeviceDefinition.deviceName:brandName", "path": "DeviceDefinition.deviceName", "sliceName": "brandName", "short": "The Brand Name of the device (as indicated by the manufacturer)", "definition": "The name or names of the device as given by the manufacturer.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:brandName.id", "path": "DeviceDefinition.deviceName.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:brandName.extension", "path": "DeviceDefinition.deviceName.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName:brandName.modifierExtension", "path": "DeviceDefinition.deviceName.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName:brandName.name", "path": "DeviceDefinition.deviceName.name", "short": "A name that is used to refer to the device", "definition": "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "alias": [ "Σ" ], "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.name", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 80, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:brandName.type", "path": "DeviceDefinition.deviceName.type", "short": "registered-name | user-friendly-name | patient-reported-name", "definition": "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "user-friendly-name", "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceNameType" } ], "strength": "required", "description": "The type of name the device is referred by.", "valueSet": "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".playedRole[typeCode=MANU].code" } ] }, { "id": "DeviceDefinition.deviceName:tradeName", "path": "DeviceDefinition.deviceName", "sliceName": "tradeName", "short": "The Trade Name of the product (as seen in the Anvisa's regularization). This field is for query only", "definition": "The name or names of the device as given by the manufacturer.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.deviceName", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:tradeName.id", "path": "DeviceDefinition.deviceName.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:tradeName.extension", "path": "DeviceDefinition.deviceName.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName:tradeName.modifierExtension", "path": "DeviceDefinition.deviceName.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.deviceName:tradeName.name", "path": "DeviceDefinition.deviceName.name", "short": "A name that is used to refer to the device", "definition": "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "alias": [ "Σ" ], "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.name", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 230, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.deviceName:tradeName.type", "path": "DeviceDefinition.deviceName.type", "short": "registered-name | user-friendly-name | patient-reported-name", "definition": "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.deviceName.type", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "registered-name", "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceNameType" } ], "strength": "required", "description": "The type of name the device is referred by.", "valueSet": "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".playedRole[typeCode=MANU].code" } ] }, { "id": "DeviceDefinition.modelNumber", "path": "DeviceDefinition.modelNumber", "short": "Version or model", "definition": "The model number for the device for example as defined by the manufacturer or labeler, or other agency.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.modelNumber", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 80, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "rim", "map": ".softwareName (included as part)" } ] }, { "id": "DeviceDefinition.classification", "path": "DeviceDefinition.classification", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "What kind of device or device system this is", "definition": "What kind of device or device system this is.", "comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.", "min": 1, "max": "3", "base": { "path": "DeviceDefinition.classification", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification.id", "path": "DeviceDefinition.classification.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification.extension", "path": "DeviceDefinition.classification.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification.modifierExtension", "path": "DeviceDefinition.classification.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification.type", "path": "DeviceDefinition.classification.type", "short": "A classification or risk class of the device model", "definition": "A classification or risk class of the device model.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.classification.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceKind" } ], "strength": "example", "description": "Type of device e.g. according to official classification.", "valueSet": "http://hl7.org/fhir/ValueSet/device-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.classification.justification", "path": "DeviceDefinition.classification.justification", "short": "Further information qualifying this classification of the device model", "definition": "Further information qualifying this classification of the device model.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.classification.justification", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm", "path": "DeviceDefinition.classification", "sliceName": "gmdnTerm", "short": "The GMDN nomenclature that characterizes the device", "definition": "What kind of device or device system this is.", "comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.classification", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm.id", "path": "DeviceDefinition.classification.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm.extension", "path": "DeviceDefinition.classification.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm.modifierExtension", "path": "DeviceDefinition.classification.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm.type", "path": "DeviceDefinition.classification.type", "short": "A classification or risk class of the device model", "definition": "A classification or risk class of the device model.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.classification.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceKind" } ], "strength": "required", "description": "Type of device e.g. according to official classification.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/GMDNTerm" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.classification:gmdnTerm.justification", "path": "DeviceDefinition.classification.justification", "short": "Further information qualifying this classification of the device model", "definition": "Further information qualifying this classification of the device model.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.classification.justification", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:riskClassification", "path": "DeviceDefinition.classification", "sliceName": "riskClassification", "short": "The risk classification of the product (as seen in the Anvisa's regularization). This field is for query only", "definition": "What kind of device or device system this is.", "comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.classification", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:riskClassification.id", "path": "DeviceDefinition.classification.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:riskClassification.extension", "path": "DeviceDefinition.classification.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:riskClassification.modifierExtension", "path": "DeviceDefinition.classification.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:riskClassification.type", "path": "DeviceDefinition.classification.type", "short": "A classification or risk class of the device model", "definition": "A classification or risk class of the device model.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.classification.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceKind" } ], "strength": "required", "description": "Type of device e.g. according to official classification.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RiskClassification" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.classification:riskClassification.justification", "path": "DeviceDefinition.classification.justification", "short": "Further information qualifying this classification of the device model", "definition": "Further information qualifying this classification of the device model.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.classification.justification", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature", "path": "DeviceDefinition.classification", "sliceName": "anvisaNomenclature", "short": "The Anvisa's nomenclature name (as seen in the Anvisa's regularization). This field is for query only", "definition": "What kind of device or device system this is.", "comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.classification", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature.id", "path": "DeviceDefinition.classification.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature.extension", "path": "DeviceDefinition.classification.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature.modifierExtension", "path": "DeviceDefinition.classification.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature.type", "path": "DeviceDefinition.classification.type", "short": "A classification or risk class of the device model", "definition": "A classification or risk class of the device model.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.classification.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceKind" } ], "strength": "required", "description": "Type of device e.g. according to official classification.", "valueSet": "https://udi.anvisa.gov.br/fhir/CodeSystem/AnvisaNomenclature" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.classification:anvisaNomenclature.justification", "path": "DeviceDefinition.classification.justification", "short": "Further information qualifying this classification of the device model", "definition": "Further information qualifying this classification of the device model.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.classification.justification", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.conformsTo", "path": "DeviceDefinition.conformsTo", "short": "Identifies the standards, specifications, or formal guidances for the capabilities supported by the device", "definition": "Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.conformsTo", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.conformsTo.id", "path": "DeviceDefinition.conformsTo.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.conformsTo.extension", "path": "DeviceDefinition.conformsTo.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.conformsTo.modifierExtension", "path": "DeviceDefinition.conformsTo.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.conformsTo.category", "path": "DeviceDefinition.conformsTo.category", "short": "Describes the common type of the standard, specification, or formal guidance", "definition": "Describes the type of the standard, specification, or formal guidance.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.conformsTo.category", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceSpecificationCategory" } ], "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/device-specification-category" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.conformsTo.specification", "path": "DeviceDefinition.conformsTo.specification", "short": "Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type", "definition": "Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.conformsTo.specification", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceSpecificationType" } ], "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/device-specification-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.conformsTo.version", "path": "DeviceDefinition.conformsTo.version", "short": "The specific form or variant of the standard, specification or formal guidance", "definition": "Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.conformsTo.version", "min": 0, "max": "*" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.conformsTo.source", "path": "DeviceDefinition.conformsTo.source", "short": "Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance", "definition": "Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.conformsTo.source", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.hasPart", "path": "DeviceDefinition.hasPart", "short": "A device, part of the current one", "definition": "A device that is part (for example a component) of the present device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.hasPart", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.hasPart.id", "path": "DeviceDefinition.hasPart.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.hasPart.extension", "path": "DeviceDefinition.hasPart.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.hasPart.modifierExtension", "path": "DeviceDefinition.hasPart.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.hasPart.reference", "path": "DeviceDefinition.hasPart.reference", "short": "Reference to the part", "definition": "Reference to the device that is part of the current device.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.hasPart.reference", "min": 1, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" } ] }, { "id": "DeviceDefinition.hasPart.count", "path": "DeviceDefinition.hasPart.count", "short": "Number of occurrences of the part", "definition": "Number of instances of the component device in the current device.", "comment": "32 bit number; for values larger than this, use decimal", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.hasPart.count", "min": 0, "max": "1" }, "type": [ { "code": "integer" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging", "path": "DeviceDefinition.packaging", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "Information about the packaging of the device, i.e. how the device is packaged", "definition": "Information about the packaging of the device, i.e. how the device is packaged.", "min": 1, "max": "*", "base": { "path": "DeviceDefinition.packaging", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.id", "path": "DeviceDefinition.packaging.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.extension", "path": "DeviceDefinition.packaging.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging.modifierExtension", "path": "DeviceDefinition.packaging.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging.identifier", "path": "DeviceDefinition.packaging.identifier", "short": "Business identifier of the packaged medication", "definition": "The business identifier of the packaged medication.", "comment": "The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ident-1", "severity": "warning", "human": "Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason", "expression": "value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Identifier" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" } ] }, { "id": "DeviceDefinition.packaging.type", "path": "DeviceDefinition.packaging.type", "short": "A code that defines the specific type of packaging", "definition": "A code that defines the specific type of packaging.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.packaging.count", "path": "DeviceDefinition.packaging.count", "short": "The number of items contained in the package (devices or sub-packages)", "definition": "The number of items contained in the package (devices or sub-packages).", "comment": "32 bit number; for values larger than this, use decimal", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.count", "min": 0, "max": "1" }, "type": [ { "code": "integer" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.distributor", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "PackagingDistributor" } ], "path": "DeviceDefinition.packaging.distributor", "short": "An organization that distributes the packaged device", "definition": "An organization that distributes the packaged device.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.distributor", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.distributor.id", "path": "DeviceDefinition.packaging.distributor.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.distributor.extension", "path": "DeviceDefinition.packaging.distributor.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging.distributor.modifierExtension", "path": "DeviceDefinition.packaging.distributor.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging.distributor.name", "path": "DeviceDefinition.packaging.distributor.name", "short": "Distributor's human-readable name", "definition": "Distributor's human-readable name.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.distributor.name", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging.distributor.organizationReference", "path": "DeviceDefinition.packaging.distributor.organizationReference", "short": "Distributor as an Organization resource", "definition": "Distributor as an Organization resource.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.distributor.organizationReference", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" } ] }, { "id": "DeviceDefinition.packaging.udiDeviceIdentifier", "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "short": "Unique Device Identifier (UDI) Barcode string on the packaging", "definition": "Unique Device Identifier (UDI) Barcode string on the packaging.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "min": 0, "max": "*" }, "contentReference": "#DeviceDefinition.udiDeviceIdentifier", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.packaging.packaging", "path": "DeviceDefinition.packaging.packaging", "short": "Allows packages within packages", "definition": "Allows packages within packages.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.packaging", "min": 0, "max": "*" }, "contentReference": "#DeviceDefinition.packaging", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.packaging:primaryPackaging", "path": "DeviceDefinition.packaging", "sliceName": "primaryPackaging", "short": "Primary Packaging. Specifies the Quantity per Primary Packaging", "definition": "Information about the packaging of the device, i.e. how the device is packaged.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.id", "path": "DeviceDefinition.packaging.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.extension", "path": "DeviceDefinition.packaging.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.modifierExtension", "path": "DeviceDefinition.packaging.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.identifier", "path": "DeviceDefinition.packaging.identifier", "short": "Business identifier of the packaged medication", "definition": "The business identifier of the packaged medication.", "comment": "The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ident-1", "severity": "warning", "human": "Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason", "expression": "value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Identifier" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.type", "path": "DeviceDefinition.packaging.type", "short": "The identification of the primary packaging", "definition": "A code that defines the specific type of packaging.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/PackagingLevel", "version": "1.0.0", "code": "1", "display": "Primary packaging" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PrimaryPackagingLevel" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.count", "path": "DeviceDefinition.packaging.count", "short": "Quantity per Primary Packaging", "definition": "The number of items contained in the package (devices or sub-packages).", "comment": "32 bit number; for values larger than this, use decimal", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging.count", "min": 0, "max": "1" }, "type": [ { "code": "integer" } ], "minValueInteger": 1, "maxValueInteger": 999999999, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "PackagingDistributor" } ], "path": "DeviceDefinition.packaging.distributor", "short": "An organization that distributes the packaged device", "definition": "An organization that distributes the packaged device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.distributor", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor.id", "path": "DeviceDefinition.packaging.distributor.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor.extension", "path": "DeviceDefinition.packaging.distributor.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor.modifierExtension", "path": "DeviceDefinition.packaging.distributor.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor.name", "path": "DeviceDefinition.packaging.distributor.name", "short": "Distributor's human-readable name", "definition": "Distributor's human-readable name.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.distributor.name", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor.organizationReference", "path": "DeviceDefinition.packaging.distributor.organizationReference", "short": "Distributor as an Organization resource", "definition": "Distributor as an Organization resource.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.distributor.organizationReference", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" } ] }, { "id": "DeviceDefinition.packaging:primaryPackaging.udiDeviceIdentifier", "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "short": "Unique Device Identifier (UDI) Barcode string on the packaging", "definition": "Unique Device Identifier (UDI) Barcode string on the packaging.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "min": 0, "max": "*" }, "contentReference": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.udiDeviceIdentifier", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.packaging:primaryPackaging.packaging", "path": "DeviceDefinition.packaging.packaging", "short": "Allows packages within packages", "definition": "Allows packages within packages.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.packaging", "min": 0, "max": "*" }, "contentReference": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.packaging", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging", "path": "DeviceDefinition.packaging", "sliceName": "higherLevelsPackaging", "short": "Identification of packaging beyond the primary packaging", "definition": "Information about the packaging of the device, i.e. how the device is packaged.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.id", "path": "DeviceDefinition.packaging.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.extension", "path": "DeviceDefinition.packaging.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.modifierExtension", "path": "DeviceDefinition.packaging.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.identifier", "path": "DeviceDefinition.packaging.identifier", "short": "Business identifier of the packaged medication", "definition": "The business identifier of the packaged medication.", "comment": "The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ident-1", "severity": "warning", "human": "Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason", "expression": "value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Identifier" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.type", "path": "DeviceDefinition.packaging.type", "short": "The Package Level", "definition": "A code that defines the specific type of packaging.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/HigherLevelsPackaging" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.count", "path": "DeviceDefinition.packaging.count", "short": "The quantity per packaging", "definition": "The number of items contained in the package (devices or sub-packages).", "comment": "32 bit number; for values larger than this, use decimal", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging.count", "min": 0, "max": "1" }, "type": [ { "code": "integer" } ], "minValueInteger": 1, "maxValueInteger": 999999999, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", "valueString": "PackagingDistributor" } ], "path": "DeviceDefinition.packaging.distributor", "short": "An organization that distributes the packaged device", "definition": "An organization that distributes the packaged device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.distributor", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor.id", "path": "DeviceDefinition.packaging.distributor.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor.extension", "path": "DeviceDefinition.packaging.distributor.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor.modifierExtension", "path": "DeviceDefinition.packaging.distributor.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor.name", "path": "DeviceDefinition.packaging.distributor.name", "short": "Distributor's human-readable name", "definition": "Distributor's human-readable name.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.packaging.distributor.name", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor.organizationReference", "path": "DeviceDefinition.packaging.distributor.organizationReference", "short": "Distributor as an Organization resource", "definition": "Distributor as an Organization resource.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.packaging.distributor.organizationReference", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" } ] }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.udiDeviceIdentifier", "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "short": "The Package UDI-DI", "definition": "Unique Device Identifier (UDI) Barcode string on the packaging.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "min": 0, "max": "*" }, "contentReference": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.udiDeviceIdentifier", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.packaging", "path": "DeviceDefinition.packaging.packaging", "short": "Allows packages within packages", "definition": "Allows packages within packages.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.packaging.packaging", "min": 0, "max": "*" }, "contentReference": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.packaging", "mustSupport": false, "isModifier": false, "isSummary": false }, { "id": "DeviceDefinition.version", "path": "DeviceDefinition.version", "short": "The version of the device or software", "definition": "The version of the device or software.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.version", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.version.id", "path": "DeviceDefinition.version.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.version.extension", "path": "DeviceDefinition.version.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.version.modifierExtension", "path": "DeviceDefinition.version.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.version.type", "path": "DeviceDefinition.version.type", "short": "The type of the device version, e.g. manufacturer, approved, internal", "definition": "The type of the device version, e.g. manufacturer, approved, internal.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "alias": [ "Σ" ], "min": 0, "max": "1", "base": { "path": "DeviceDefinition.version.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.version.component", "path": "DeviceDefinition.version.component", "short": "The hardware or software module of the device to which the version applies", "definition": "The hardware or software module of the device to which the version applies.", "comment": "Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.version.component", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ident-1", "severity": "warning", "human": "Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason", "expression": "value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Identifier" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "identity": "w5", "map": "FiveWs.what[x]" } ] }, { "id": "DeviceDefinition.version.value", "path": "DeviceDefinition.version.value", "short": "The version text", "definition": "The version text.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.version.value", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.safety", "path": "DeviceDefinition.safety", "short": "The MRI safety status. Specify the level of product safety in an operating magnetic resonance environment", "definition": "Safety characteristics of the device.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.safety", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Safety" } ], "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/MRSafetyStatus" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.shelfLifeStorage", "path": "DeviceDefinition.shelfLifeStorage", "short": "Shelf Life and storage information", "definition": "Shelf Life and storage information.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.shelfLifeStorage", "min": 0, "max": "*" }, "type": [ { "code": "ProductShelfLife" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "administrative.medication" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.id", "path": "DeviceDefinition.shelfLifeStorage.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.extension", "path": "DeviceDefinition.shelfLifeStorage.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.extension:specialPrecautionsForStorageDescription", "path": "DeviceDefinition.shelfLifeStorage.extension", "sliceName": "specialPrecautionsForStorageDescription", "short": "Specify storage and/or handling conditions that may directly impact the product's safety and efficacy", "definition": "Optional Extension Element - found in all resources.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/SpecialPrecautionsForStorageDescription" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.modifierExtension", "path": "DeviceDefinition.shelfLifeStorage.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneType.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.type", "path": "DeviceDefinition.shelfLifeStorage.type", "short": "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified", "definition": "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "0", "base": { "path": "ProductShelfLife.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.period[x]", "path": "DeviceDefinition.shelfLifeStorage.period[x]", "short": "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used", "definition": "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.", "min": 0, "max": "0", "base": { "path": "ProductShelfLife.period[x]", "min": 0, "max": "1" }, "type": [ { "code": "Duration" }, { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage", "short": "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified", "definition": "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "0", "base": { "path": "ProductShelfLife.specialPrecautionsForStorage", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.id", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.extension", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.coding", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.coding", "short": "Code defined by a terminology system", "definition": "A reference to a code defined by a terminology system.", "comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.", "requirements": "Allows for alternative encodings within a code system, and translations to other code systems.", "min": 0, "max": "*", "base": { "path": "CodeableConcept.coding", "min": 0, "max": "*" }, "type": [ { "code": "Coding" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cod-1", "severity": "warning", "human": "A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text", "expression": "code.exists().not() implies display.exists().not()", "source": "http://hl7.org/fhir/StructureDefinition/Coding" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" }, { "identity": "rim", "map": "CV" }, { "identity": "orim", "map": "fhir:Coding rdfs:subClassOf dt:CDCoding" }, { "identity": "v2", "map": "C*E.1-8, C*E.10-22" }, { "identity": "rim", "map": "union(., ./translation)" }, { "identity": "orim", "map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" } ] }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true } ], "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text", "short": "Plain text representation of the concept", "definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.", "comment": "Very often the text is the same as a displayName of one of the codings.", "requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.", "min": 1, "max": "1", "base": { "path": "CodeableConcept.text", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "C*E.9. But note many systems use C*E.2 for this" }, { "identity": "rim", "map": "./originalText[mediaType/code=\"text/plain\"]/data" }, { "identity": "orim", "map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" } ] }, { "id": "DeviceDefinition.languageCode", "path": "DeviceDefinition.languageCode", "short": "Language code for the human-readable text strings produced by the device (all supported)", "definition": "Language code for the human-readable text strings produced by the device (all supported).", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.languageCode", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property", "path": "DeviceDefinition.property", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "Quantity" }, { "code": "CodeableConcept" }, { "code": "string" }, { "code": "boolean" }, { "code": "integer" }, { "code": "Range" }, { "code": "Attachment" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:deviceCategory", "path": "DeviceDefinition.property", "sliceName": "deviceCategory", "short": "Specify if the product corresponds to material, implantable material, equipment, implantable equipment, IVD, or SaMD", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:deviceCategory.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:deviceCategory.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:deviceCategory.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:deviceCategory.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "device-category", "display": "Medical Device Category" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:deviceCategory.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/DeviceCategory" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:singleUse", "path": "DeviceDefinition.property", "sliceName": "singleUse", "short": "Indicates if the device labeled as single-use", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:singleUse.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:singleUse.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:singleUse.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:singleUse.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "single-use", "display": "Device labeled as single-use" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:singleUse.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:reusableDevice", "path": "DeviceDefinition.property", "sliceName": "reusableDevice", "short": "Indicates if the device is reusable", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:reusableDevice.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:reusableDevice.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:reusableDevice.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:reusableDevice.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "reusable-device", "display": "Reusable device" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:reusableDevice.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles", "path": "DeviceDefinition.property", "sliceName": "recommendedReprocessingCyles", "short": "Specify the number of recommended reprocessing cycles", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "recommended-reprocessing-cyles", "display": "Number of reprocessing cycles recommended" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "Quantity" } ], "minValueQuantity": { "value": 1 }, "maxValueQuantity": { "value": 999999 }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile", "path": "DeviceDefinition.property", "sliceName": "labeledAsSterile", "short": "Indicates if the device is labeled as sterile", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "labeled-as-sterile", "display": "Device labeled as sterile" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:labeledAsSterile.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:requiresSterilization", "path": "DeviceDefinition.property", "sliceName": "requiresSterilization", "short": "Indicates if the device requires sterilization before use", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:requiresSterilization.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:requiresSterilization.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:requiresSterilization.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:requiresSterilization.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "requires-sterilization", "display": "Requires sterilization before use" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:requiresSterilization.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod", "path": "DeviceDefinition.property", "sliceName": "sterilizationMethod", "short": "Sterilization method", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "sterilization-method", "display": "Sterilization Method" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/SterilizationMethod" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:layUse", "path": "DeviceDefinition.property", "sliceName": "layUse", "short": "Indicates if the device can be used by a lay user", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:layUse.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:layUse.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:layUse.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:layUse.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "lay-use", "display": "Intended for use by a lay user" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:layUse.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:incorporatesAi", "path": "DeviceDefinition.property", "sliceName": "incorporatesAi", "short": "Indicates if the product incorporates AI (artificial intelligence) in any device function", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:incorporatesAi.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:incorporatesAi.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:incorporatesAi.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:incorporatesAi.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "incorporates-ai", "display": "Incorporates Artificial Inteligence into the medical device function" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:incorporatesAi.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:combinationProduct", "path": "DeviceDefinition.property", "sliceName": "combinationProduct", "short": "Indicates if the product is associated with any pharmaceutical product that has a secondary function in the device", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:combinationProduct.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:combinationProduct.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:combinationProduct.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:combinationProduct.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "combination-product", "display": "Combination product" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:combinationProduct.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes", "path": "DeviceDefinition.property", "sliceName": "clinicallyRelevantSizes", "short": "Specify dimensional characteristics that are relevant for the product's clinical function", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "clinically-relevant-sizes", "display": "Clinically Relevant Sizes" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 5000, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:batchNumber", "path": "DeviceDefinition.property", "sliceName": "batchNumber", "short": "Indicates the presence of lot or Batch Number", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:batchNumber.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:batchNumber.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:batchNumber.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:batchNumber.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "batch-number", "display": "Lot or Batch Number" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:batchNumber.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:serialNumber", "path": "DeviceDefinition.property", "sliceName": "serialNumber", "short": "Indicates the presence of serial number", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:serialNumber.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:serialNumber.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:serialNumber.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:serialNumber.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "serial-number", "display": "Serial Number" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:serialNumber.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:expirationDate", "path": "DeviceDefinition.property", "sliceName": "expirationDate", "short": "Indicates the presence of expiration date", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:expirationDate.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:expirationDate.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:expirationDate.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:expirationDate.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "expiration-date", "display": "Expiration date" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:expirationDate.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate", "path": "DeviceDefinition.property", "sliceName": "manufRecondReprocDate", "short": "Indicates the presence of a Manufacture or Refurbishing/Reprocessing date", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "manuf-recond-reproc-date", "display": "Manufacture or Refurbishing/Reprocessing date" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate", "path": "DeviceDefinition.property", "sliceName": "samdReleaseDate", "short": "Indicates the presence of SaMD release date", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "samd-release-date", "display": "SaMD release date" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdVersion", "path": "DeviceDefinition.property", "sliceName": "samdVersion", "short": "Indicates the presence of SaMD version", "definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.", "comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.property", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdVersion.id", "path": "DeviceDefinition.property.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.property:samdVersion.extension", "path": "DeviceDefinition.property.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:samdVersion.modifierExtension", "path": "DeviceDefinition.property.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.property:samdVersion.type", "path": "DeviceDefinition.property.type", "short": "Code that specifies the property being represented", "definition": "Code that specifies the property such as a resolution or color being represented.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "samd-version", "display": "SaMD version" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DevicePropertyType" } ], "strength": "example", "description": "Device property type.", "valueSet": "http://hl7.org/fhir/ValueSet/device-property-type" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.property:samdVersion.value[x]", "path": "DeviceDefinition.property.value[x]", "short": "Value of the property", "definition": "The value of the property specified by the associated property.type code.", "comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.property.value[x]", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.owner", "path": "DeviceDefinition.owner", "short": "Organization responsible for device", "definition": "An organization that is responsible for the provision and ongoing maintenance of the device.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.owner", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-2", "severity": "error", "human": "At least one of reference, identifier and display SHALL be present (unless an extension is provided).", "expression": "reference.exists() or identifier.exists() or display.exists() or extension.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "w5", "map": "FiveWs.source" }, { "identity": "rim", "map": ".playedRole[typeCode=OWN].scoper" } ] }, { "id": "DeviceDefinition.contact", "path": "DeviceDefinition.contact", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "Details for human/organization for support", "definition": "Contact details for an organization or a particular human that is responsible for the device.", "comment": "used for troubleshooting etc.", "min": 1, "max": "2", "base": { "path": "DeviceDefinition.contact", "min": 0, "max": "*" }, "type": [ { "code": "ContactPoint" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cpt-2", "severity": "error", "human": "A system is required if a value is provided.", "expression": "value.empty() or system.exists()", "source": "http://hl7.org/fhir/StructureDefinition/ContactPoint" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN" }, { "identity": "rim", "map": "TEL" }, { "identity": "servd", "map": "ContactPoint" }, { "identity": "w5", "map": "FiveWs.source" }, { "identity": "rim", "map": ".scopedRole[typeCode=CON].player" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo", "path": "DeviceDefinition.contact", "sliceName": "urlForAdditionalInfo", "short": "URL for additional information. Fill out whenever the company wants to indicate a URL where additional product information can be found (e.g., company website with product catalog or electronic instructions for use)", "definition": "Contact details for an organization or a particular human that is responsible for the device.", "comment": "used for troubleshooting etc.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.contact", "min": 0, "max": "*" }, "type": [ { "code": "ContactPoint" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cpt-2", "severity": "error", "human": "A system is required if a value is provided.", "expression": "value.empty() or system.exists()", "source": "http://hl7.org/fhir/StructureDefinition/ContactPoint" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN" }, { "identity": "rim", "map": "TEL" }, { "identity": "servd", "map": "ContactPoint" }, { "identity": "w5", "map": "FiveWs.source" }, { "identity": "rim", "map": ".scopedRole[typeCode=CON].player" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.id", "path": "DeviceDefinition.contact.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.extension", "path": "DeviceDefinition.contact.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.system", "path": "DeviceDefinition.contact.system", "short": "phone | fax | email | pager | url | sms | other", "definition": "Telecommunications form for contact point - what communications system is required to make use of the contact.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "ContactPoint.system", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "url", "condition": [ "cpt-2" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition", "valueString": "Telecommunications form for contact point." }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ContactPointSystem" } ], "strength": "required", "description": "Telecommunications form for contact point.", "valueSet": "http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.3" }, { "identity": "rim", "map": "./scheme" }, { "identity": "servd", "map": "./ContactPointType" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.value", "path": "DeviceDefinition.contact.value", "short": "The actual contact point details", "definition": "The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).", "comment": "Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.", "requirements": "Need to support legacy numbers that are not in a tightly controlled format.", "min": 1, "max": "1", "base": { "path": "ContactPoint.value", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 5000, "condition": [ "cpt-2" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.1 (or XTN.12)" }, { "identity": "rim", "map": "./url" }, { "identity": "servd", "map": "./Value" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.use", "path": "DeviceDefinition.contact.use", "short": "home | work | temp | old | mobile - purpose of this contact point", "definition": "Identifies the purpose for the contact point.", "comment": "Applications can assume that a contact is current unless it explicitly says that it is temporary or old.", "requirements": "Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.", "min": 0, "max": "0", "base": { "path": "ContactPoint.use", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": true, "isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary or old contact etc.for a current/permanent one", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition", "valueString": "Use of contact point." }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ContactPointUse" } ], "strength": "required", "description": "Use of contact point.", "valueSet": "http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.2 - but often indicated by field" }, { "identity": "rim", "map": "unique(./use)" }, { "identity": "servd", "map": "./ContactPointPurpose" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.rank", "path": "DeviceDefinition.contact.rank", "short": "Specify preferred order of use (1 = highest)", "definition": "Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.", "comment": "Note that rank does not necessarily follow the order in which the contacts are represented in the instance.\n\nRanks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean \"X is my most preferred phone number, Y is my most preferred email address\" or \"X is my preferred home email and Y is my preferred work email\". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions. \n\nRanks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.", "min": 0, "max": "0", "base": { "path": "ContactPoint.rank", "min": 0, "max": "1" }, "type": [ { "code": "positiveInt" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "n/a" } ] }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.period", "path": "DeviceDefinition.contact.period", "short": "Time period when the contact point was/is in use", "definition": "Time period when the contact point was/is in use.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 0, "max": "0", "base": { "path": "ContactPoint.period", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "./usablePeriod[type=\"IVL\"]" }, { "identity": "servd", "map": "./StartDate and ./EndDate" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo", "path": "DeviceDefinition.contact", "sliceName": "manufacCustomerServiceInfo", "short": "Manufacturer’s Customer Service Contact Information (as indicated on the label)", "definition": "Contact details for an organization or a particular human that is responsible for the device.", "comment": "used for troubleshooting etc.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.contact", "min": 0, "max": "*" }, "type": [ { "code": "ContactPoint" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cpt-2", "severity": "error", "human": "A system is required if a value is provided.", "expression": "value.empty() or system.exists()", "source": "http://hl7.org/fhir/StructureDefinition/ContactPoint" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN" }, { "identity": "rim", "map": "TEL" }, { "identity": "servd", "map": "ContactPoint" }, { "identity": "w5", "map": "FiveWs.source" }, { "identity": "rim", "map": ".scopedRole[typeCode=CON].player" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.id", "path": "DeviceDefinition.contact.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.extension", "path": "DeviceDefinition.contact.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.system", "path": "DeviceDefinition.contact.system", "short": "phone | fax | email | pager | url | sms | other", "definition": "Telecommunications form for contact point - what communications system is required to make use of the contact.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 1, "max": "1", "base": { "path": "ContactPoint.system", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "other", "condition": [ "cpt-2" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition", "valueString": "Telecommunications form for contact point." }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ContactPointSystem" } ], "strength": "required", "description": "Telecommunications form for contact point.", "valueSet": "http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.3" }, { "identity": "rim", "map": "./scheme" }, { "identity": "servd", "map": "./ContactPointType" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.value", "path": "DeviceDefinition.contact.value", "short": "The actual contact point details", "definition": "The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).", "comment": "Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.", "requirements": "Need to support legacy numbers that are not in a tightly controlled format.", "min": 1, "max": "1", "base": { "path": "ContactPoint.value", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "maxLength": 5000, "condition": [ "cpt-2" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.1 (or XTN.12)" }, { "identity": "rim", "map": "./url" }, { "identity": "servd", "map": "./Value" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.use", "path": "DeviceDefinition.contact.use", "short": "home | work | temp | old | mobile - purpose of this contact point", "definition": "Identifies the purpose for the contact point.", "comment": "Applications can assume that a contact is current unless it explicitly says that it is temporary or old.", "requirements": "Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.", "min": 0, "max": "0", "base": { "path": "ContactPoint.use", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isModifier": true, "isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary or old contact etc.for a current/permanent one", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/binding-definition", "valueString": "Use of contact point." }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ContactPointUse" } ], "strength": "required", "description": "Use of contact point.", "valueSet": "http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN.2 - but often indicated by field" }, { "identity": "rim", "map": "unique(./use)" }, { "identity": "servd", "map": "./ContactPointPurpose" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.rank", "path": "DeviceDefinition.contact.rank", "short": "Specify preferred order of use (1 = highest)", "definition": "Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.", "comment": "Note that rank does not necessarily follow the order in which the contacts are represented in the instance.\n\nRanks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean \"X is my most preferred phone number, Y is my most preferred email address\" or \"X is my preferred home email and Y is my preferred work email\". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions. \n\nRanks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.", "min": 0, "max": "0", "base": { "path": "ContactPoint.rank", "min": 0, "max": "1" }, "type": [ { "code": "positiveInt" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "n/a" } ] }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.period", "path": "DeviceDefinition.contact.period", "short": "Time period when the contact point was/is in use", "definition": "Time period when the contact point was/is in use.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 0, "max": "0", "base": { "path": "ContactPoint.period", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "./usablePeriod[type=\"IVL\"]" }, { "identity": "servd", "map": "./StartDate and ./EndDate" } ] }, { "id": "DeviceDefinition.link", "path": "DeviceDefinition.link", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device", "definition": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.", "min": 0, "max": "2", "base": { "path": "DeviceDefinition.link", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link.id", "path": "DeviceDefinition.link.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link.extension", "path": "DeviceDefinition.link.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link.modifierExtension", "path": "DeviceDefinition.link.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link.relation", "path": "DeviceDefinition.link.relation", "short": "The type indicates the relationship of the related device to the device instance", "definition": "The type indicates the relationship of the related device to the device instance.", "comment": "Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relation", "min": 1, "max": "1" }, "type": [ { "code": "Coding" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cod-1", "severity": "warning", "human": "A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text", "expression": "code.exists().not() implies display.exists().not()", "source": "http://hl7.org/fhir/StructureDefinition/Coding" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceDefinitionRelationType" } ], "strength": "extensible", "description": "The type of relation between this and the linked device.", "valueSet": "http://hl7.org/fhir/ValueSet/devicedefinition-relationtype" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" }, { "identity": "rim", "map": "CV" }, { "identity": "orim", "map": "fhir:Coding rdfs:subClassOf dt:CDCoding" } ] }, { "id": "DeviceDefinition.link.relatedDevice", "path": "DeviceDefinition.link.relatedDevice", "short": "A reference to the linked device", "definition": "A reference to the linked device.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relatedDevice", "min": 1, "max": "1" }, "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:attachedRecord", "path": "DeviceDefinition.link", "sliceName": "attachedRecord", "short": "Another registration to which this record is attached", "definition": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.link", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:attachedRecord.id", "path": "DeviceDefinition.link.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:attachedRecord.extension", "path": "DeviceDefinition.link.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link:attachedRecord.modifierExtension", "path": "DeviceDefinition.link.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link:attachedRecord.relation", "path": "DeviceDefinition.link.relation", "short": "The type indicates the relationship of the related device to the device instance", "definition": "The type indicates the relationship of the related device to the device instance.", "comment": "Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relation", "min": 1, "max": "1" }, "type": [ { "code": "Coding" } ], "fixedCoding": { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/RelationType", "version": "1.0.0", "code": "attached", "display": "The current registration is being attached to another" }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cod-1", "severity": "warning", "human": "A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text", "expression": "code.exists().not() implies display.exists().not()", "source": "http://hl7.org/fhir/StructureDefinition/Coding" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceDefinitionRelationType" } ], "strength": "required", "description": "The type of relation between this and the linked device.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/AttachedRelationType" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" }, { "identity": "rim", "map": "CV" }, { "identity": "orim", "map": "fhir:Coding rdfs:subClassOf dt:CDCoding" } ] }, { "id": "DeviceDefinition.link:attachedRecord.relatedDevice", "path": "DeviceDefinition.link.relatedDevice", "short": "A reference to the linked device", "definition": "A reference to the linked device.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relatedDevice", "min": 1, "max": "1" }, "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:previousRecord", "path": "DeviceDefinition.link", "sliceName": "previousRecord", "short": "A previous registration replaced by this record", "definition": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.link", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:previousRecord.id", "path": "DeviceDefinition.link.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.link:previousRecord.extension", "path": "DeviceDefinition.link.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link:previousRecord.modifierExtension", "path": "DeviceDefinition.link.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.link:previousRecord.relation", "path": "DeviceDefinition.link.relation", "short": "The type indicates the relationship of the related device to the device instance", "definition": "The type indicates the relationship of the related device to the device instance.", "comment": "Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relation", "min": 1, "max": "1" }, "type": [ { "code": "Coding" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "cod-1", "severity": "warning", "human": "A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text", "expression": "code.exists().not() implies display.exists().not()", "source": "http://hl7.org/fhir/StructureDefinition/Coding" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceDefinitionRelationType" } ], "strength": "required", "description": "The type of relation between this and the linked device.", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PreviousRelationType" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" }, { "identity": "rim", "map": "CV" }, { "identity": "orim", "map": "fhir:Coding rdfs:subClassOf dt:CDCoding" } ] }, { "id": "DeviceDefinition.link:previousRecord.relatedDevice", "path": "DeviceDefinition.link.relatedDevice", "short": "A reference to the linked device", "definition": "A reference to the linked device.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.link.relatedDevice", "min": 1, "max": "1" }, "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.note", "path": "DeviceDefinition.note", "short": "Device notes and comments", "definition": "Descriptive information, usage information or implantation information that is not captured in an existing element.", "comment": "For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. *Annotations SHOULD NOT* be used to communicate \"modifying\" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.note", "min": 0, "max": "*" }, "type": [ { "code": "Annotation" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act" }, { "identity": "rim", "map": ".text" } ] }, { "id": "DeviceDefinition.material", "path": "DeviceDefinition.material", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "short": "A substance used to create the material(s) of which the device is made", "definition": "A substance used to create the material(s) of which the device is made.", "min": 0, "max": "2", "base": { "path": "DeviceDefinition.material", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material.id", "path": "DeviceDefinition.material.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material.extension", "path": "DeviceDefinition.material.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material.modifierExtension", "path": "DeviceDefinition.material.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material.substance", "path": "DeviceDefinition.material.substance", "short": "A relevant substance that the device contains, may contain, or is made of", "definition": "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.material.substance", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.material.alternate", "path": "DeviceDefinition.material.alternate", "short": "Indicates an alternative material of the device", "definition": "Indicates an alternative material of the device.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.material.alternate", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material.allergenicIndicator", "path": "DeviceDefinition.material.allergenicIndicator", "short": "Whether the substance is a known or suspected allergen", "definition": "Whether the substance is a known or suspected allergen.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.material.allergenicIndicator", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:biologicMaterial", "path": "DeviceDefinition.material", "sliceName": "biologicMaterial", "short": "Indicates if any component of the product has origins in cells, tissues, or their non-viable derivatives (without metabolism or multiplication capability) or made non-viable", "definition": "A substance used to create the material(s) of which the device is made.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.material", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.id", "path": "DeviceDefinition.material.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.extension", "path": "DeviceDefinition.material.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.modifierExtension", "path": "DeviceDefinition.material.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.substance", "path": "DeviceDefinition.material.substance", "short": "A relevant substance that the device contains, may contain, or is made of", "definition": "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.material.substance", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType", "version": "1.0.0", "code": "biologic-material", "display": "Biological tissues/cells or their derivatives" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.alternate", "path": "DeviceDefinition.material.alternate", "short": "Indicates an alternative material of the device", "definition": "Indicates an alternative material of the device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.material.alternate", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:biologicMaterial.allergenicIndicator", "path": "DeviceDefinition.material.allergenicIndicator", "short": "Whether the substance is a known or suspected allergen", "definition": "Whether the substance is a known or suspected allergen.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.material.allergenicIndicator", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:naturalLatex", "path": "DeviceDefinition.material", "sliceName": "naturalLatex", "short": "Indicates if the device is labeled as \"Contain natural latex. May cause allergy\"", "definition": "A substance used to create the material(s) of which the device is made.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.material", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:naturalLatex.id", "path": "DeviceDefinition.material.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:naturalLatex.extension", "path": "DeviceDefinition.material.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material:naturalLatex.modifierExtension", "path": "DeviceDefinition.material.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.material:naturalLatex.substance", "path": "DeviceDefinition.material.substance", "short": "A relevant substance that the device contains, may contain, or is made of", "definition": "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.material.substance", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType", "version": "1.0.0", "code": "natural-latex", "display": "Natural latex" } ] }, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.material:naturalLatex.alternate", "path": "DeviceDefinition.material.alternate", "short": "Indicates an alternative material of the device", "definition": "Indicates an alternative material of the device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.material.alternate", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.material:naturalLatex.allergenicIndicator", "path": "DeviceDefinition.material.allergenicIndicator", "short": "Whether the substance is a known or suspected allergen", "definition": "Whether the substance is a known or suspected allergen.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.material.allergenicIndicator", "min": 0, "max": "1" }, "type": [ { "code": "boolean" } ], "fixedBoolean": true, "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.productionIdentifierInUDI", "path": "DeviceDefinition.productionIdentifierInUDI", "short": "lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version", "definition": "Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.productionIdentifierInUDI", "min": 0, "max": "*" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceProductionIdentifierInUDI" } ], "strength": "required", "description": "The production identifier(s) that are expected to appear in the UDI carrier.", "valueSet": "http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline", "path": "DeviceDefinition.guideline", "short": "Information aimed at providing directions for the usage of this model of device", "definition": "Information aimed at providing directions for the usage of this model of device.", "comment": "For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.guideline", "min": 0, "max": "1" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline.id", "path": "DeviceDefinition.guideline.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline.extension", "path": "DeviceDefinition.guideline.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.guideline.extension:warningDescription", "path": "DeviceDefinition.guideline.extension", "sliceName": "warningDescription", "short": "Additional critical warnings and contraindications for use", "definition": "Optional Extension Element - found in all resources.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/WarningDescription" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.guideline.modifierExtension", "path": "DeviceDefinition.guideline.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.guideline.useContext", "path": "DeviceDefinition.guideline.useContext", "short": "The circumstances that form the setting for using the device", "definition": "The circumstances that form the setting for using the device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.useContext", "min": 0, "max": "*" }, "type": [ { "code": "UsageContext" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline.usageInstruction", "path": "DeviceDefinition.guideline.usageInstruction", "short": "Detailed written and visual directions for the user on how to use the device", "definition": "Detailed written and visual directions for the user on how to use the device.", "comment": "Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.usageInstruction", "min": 0, "max": "1" }, "type": [ { "code": "markdown" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline.relatedArtifact", "path": "DeviceDefinition.guideline.relatedArtifact", "short": "A source of information or reference for this guideline", "definition": "A source of information or reference for this guideline.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.relatedArtifact", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.guideline.indication", "path": "DeviceDefinition.guideline.indication", "short": "A clinical condition for which the device was designed to be used", "definition": "A clinical condition for which the device was designed to be used.", "comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.indication", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.guideline.contraindication", "path": "DeviceDefinition.guideline.contraindication", "short": "A specific situation when a device should not be used because it may cause harm", "definition": "A specific situation when a device should not be used because it may cause harm.", "comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.contraindication", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.guideline.warning", "path": "DeviceDefinition.guideline.warning", "short": "Specific hazard alert information that a user needs to know before using the device", "definition": "Specific hazard alert information that a user needs to know before using the device.", "comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.warning", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "DeviceDefinition.guideline.intendedUse", "path": "DeviceDefinition.guideline.intendedUse", "short": "A description of the general purpose or medical use of the device or its function", "definition": "A description of the general purpose or medical use of the device or its function.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.guideline.intendedUse", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.correctiveAction", "path": "DeviceDefinition.correctiveAction", "short": "Tracking of latest field safety corrective action", "definition": "Tracking of latest field safety corrective action.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.correctiveAction", "min": 0, "max": "1" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.correctiveAction.id", "path": "DeviceDefinition.correctiveAction.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.correctiveAction.extension", "path": "DeviceDefinition.correctiveAction.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.correctiveAction.modifierExtension", "path": "DeviceDefinition.correctiveAction.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.correctiveAction.recall", "path": "DeviceDefinition.correctiveAction.recall", "short": "Whether the corrective action was a recall", "definition": "Whether the last corrective action known for this device was a recall.", "comment": "When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.correctiveAction.recall", "min": 1, "max": "1" }, "type": [ { "code": "boolean" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.correctiveAction.scope", "path": "DeviceDefinition.correctiveAction.scope", "short": "model | lot-numbers | serial-numbers", "definition": "The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.", "comment": "Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.correctiveAction.scope", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DeviceCorrectiveActionScope" } ], "strength": "required", "description": "The type or scope of the corrective action.", "valueSet": "http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.correctiveAction.period", "path": "DeviceDefinition.correctiveAction.period", "short": "Start and end dates of the corrective action", "definition": "Start and end dates of the corrective action.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.correctiveAction.period", "min": 1, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" } ] }, { "id": "DeviceDefinition.chargeItem", "path": "DeviceDefinition.chargeItem", "short": "Billing code or reference associated with the device", "definition": "Billing code or reference associated with the device.", "min": 0, "max": "0", "base": { "path": "DeviceDefinition.chargeItem", "min": 0, "max": "*" }, "type": [ { "code": "BackboneElement" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.chargeItem.id", "path": "DeviceDefinition.chargeItem.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "condition": [ "ele-1" ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.chargeItem.extension", "path": "DeviceDefinition.chargeItem.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.chargeItem.modifierExtension", "path": "DeviceDefinition.chargeItem.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "ext-1", "severity": "error", "human": "Must have either extensions or value[x], not both", "expression": "extension.exists() != value.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Extension" } ], "isModifier": true, "isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "DeviceDefinition.chargeItem.chargeItemCode", "path": "DeviceDefinition.chargeItem.chargeItemCode", "short": "The code or reference for the charge item", "definition": "The code or reference for the charge item.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.chargeItem.chargeItemCode", "min": 1, "max": "1" }, "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ChargeItemDefinition" ] } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "DeviceDefinition.chargeItem.count", "path": "DeviceDefinition.chargeItem.count", "short": "Coefficient applicable to the billing code", "definition": "Coefficient applicable to the billing code.", "comment": "The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.", "min": 1, "max": "1", "base": { "path": "DeviceDefinition.chargeItem.count", "min": 1, "max": "1" }, "type": [ { "code": "Quantity" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "qty-3", "severity": "error", "human": "If a code for the unit is present, the system SHALL also be present", "expression": "code.empty() or system.exists()", "source": "http://hl7.org/fhir/StructureDefinition/Quantity" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "SN (see also Range) or CQ" }, { "identity": "rim", "map": "PQ, IVL, MO, CO, depending on the values" } ] }, { "id": "DeviceDefinition.chargeItem.effectivePeriod", "path": "DeviceDefinition.chargeItem.effectivePeriod", "short": "A specific time period in which this charge item applies", "definition": "A specific time period in which this charge item applies.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "min": 0, "max": "1", "base": { "path": "DeviceDefinition.chargeItem.effectivePeriod", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower or equal value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" } ] }, { "id": "DeviceDefinition.chargeItem.useContext", "path": "DeviceDefinition.chargeItem.useContext", "short": "The context to which this charge item applies", "definition": "The context to which this charge item applies.", "min": 0, "max": "*", "base": { "path": "DeviceDefinition.chargeItem.useContext", "min": 0, "max": "*" }, "type": [ { "code": "UsageContext" } ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() or (children().count() > id.count())", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": false, "isModifier": false, "isSummary": false, "mapping": [ { "identity": "rim", "map": "n/a" } ] } ] }, "differential": { "element": [ { "id": "DeviceDefinition", "path": "DeviceDefinition", "short": "Representation of a device registration instance in the UDI system" }, { "id": "DeviceDefinition.extension", "path": "DeviceDefinition.extension", "min": 1 }, { "id": "DeviceDefinition.extension:refurbisherReprocessingCompany", "path": "DeviceDefinition.extension", "sliceName": "refurbisherReprocessingCompany", "short": "Refurbisher/Reprocessing Company's information", "max": "1", "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/RefurbisherReprocessingCompany" ] } ] }, { "id": "DeviceDefinition.extension:legalManufacturer", "path": "DeviceDefinition.extension", "sliceName": "legalManufacturer", "short": "Legal Manufacturer's information", "min": 1, "max": "1", "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/LegalManufacturer" ] } ] }, { "id": "DeviceDefinition.description", "path": "DeviceDefinition.description", "max": "0" }, { "id": "DeviceDefinition.identifier", "path": "DeviceDefinition.identifier", "max": "0" }, { "id": "DeviceDefinition.udiDeviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 1, "max": "2" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier", "sliceName": "udiDeviceIdentifier", "short": "UDI-DI of the device", "min": 1, "max": "1" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "max": "1" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.extension:repurposingType", "path": "DeviceDefinition.udiDeviceIdentifier.extension", "sliceName": "repurposingType", "short": "Identification of the type of repurposing applied to this UDI-DI's device", "max": "1", "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/RepurposingType" ] } ], "isModifier": false }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.deviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "short": "The UDI-DI number associated with the device", "maxLength": 25 }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.issuer", "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "short": "The UDI-DI's issuer", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" } }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.jurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "max": "1" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.start", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start", "short": "Specify the date from which the company wishes the data to be made public. If left blank, the system will consider the submission date to publish the submitted information" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.marketPeriod.end", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end", "short": "Specify the date when the product will be discontinued, no longer offered on the market" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifier.marketDistribution.subJurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction", "short": "National jurisdiction. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal", "path": "DeviceDefinition.udiDeviceIdentifier", "sliceName": "udiDeviceIdentifierOriginal", "short": "UDI-DI of the original device who is being refurbished/reprocessed", "max": "1" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.deviceIdentifier", "path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier", "short": "The UDI-DI number associated with the device", "maxLength": 25 }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.issuer", "path": "DeviceDefinition.udiDeviceIdentifier.issuer", "short": "The UDI-DI's issuer", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/UDIIssuer" } }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.jurisdiction", "path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction", "short": "The jurisdiction applied. By standard it's mandatory, but in this case will be ignored. Can be filled with the same value as the \"issuer\" field" }, { "id": "DeviceDefinition.udiDeviceIdentifier:udiDeviceIdentifierOriginal.marketDistribution", "path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution", "max": "0" }, { "id": "DeviceDefinition.regulatoryIdentifier", "path": "DeviceDefinition.regulatoryIdentifier", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 1, "max": "2" }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber", "path": "DeviceDefinition.regulatoryIdentifier", "sliceName": "premarketAuthorizationNumber", "short": "The Premarket Authorization Number seen in the Anvisa's product registration", "min": 1, "max": "1" }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.type", "path": "DeviceDefinition.regulatoryIdentifier.type", "short": "license | unit-of-use", "fixedCode": "license", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" } }, { "id": "DeviceDefinition.regulatoryIdentifier:premarketAuthorizationNumber.deviceIdentifier", "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "maxLength": 11 }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber", "path": "DeviceDefinition.regulatoryIdentifier", "sliceName": "unitOfUseNumber", "short": "The Unit of Use (UOU) DI Number - Identifier assigned to the individual medical device where UDI is not labeled at the unit of use level", "max": "1" }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.type", "path": "DeviceDefinition.regulatoryIdentifier.type", "short": "license | unit-of-use", "fixedCode": "unit-of-use", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegulatoryIdentifier|1.0.0" } }, { "id": "DeviceDefinition.regulatoryIdentifier:unitOfUseNumber.deviceIdentifier", "path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier", "patternString": "[0-9]+", "maxLength": 23 }, { "id": "DeviceDefinition.partNumber", "path": "DeviceDefinition.partNumber", "short": "Catalog Number", "maxLength": 80 }, { "id": "DeviceDefinition.manufacturer", "path": "DeviceDefinition.manufacturer", "max": "0" }, { "id": "DeviceDefinition.deviceName", "path": "DeviceDefinition.deviceName", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 2, "max": "2" }, { "id": "DeviceDefinition.deviceName:brandName", "path": "DeviceDefinition.deviceName", "sliceName": "brandName", "short": "The Brand Name of the device (as indicated by the manufacturer)", "min": 1, "max": "1" }, { "id": "DeviceDefinition.deviceName:brandName.name", "path": "DeviceDefinition.deviceName.name", "maxLength": 80 }, { "id": "DeviceDefinition.deviceName:brandName.type", "path": "DeviceDefinition.deviceName.type", "fixedCode": "user-friendly-name" }, { "id": "DeviceDefinition.deviceName:tradeName", "path": "DeviceDefinition.deviceName", "sliceName": "tradeName", "short": "The Trade Name of the product (as seen in the Anvisa's regularization). This field is for query only", "max": "1" }, { "id": "DeviceDefinition.deviceName:tradeName.name", "path": "DeviceDefinition.deviceName.name", "maxLength": 230 }, { "id": "DeviceDefinition.deviceName:tradeName.type", "path": "DeviceDefinition.deviceName.type", "fixedCode": "registered-name" }, { "id": "DeviceDefinition.modelNumber", "path": "DeviceDefinition.modelNumber", "short": "Version or model", "min": 1, "maxLength": 80 }, { "id": "DeviceDefinition.classification", "path": "DeviceDefinition.classification", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 1, "max": "3" }, { "id": "DeviceDefinition.classification:gmdnTerm", "path": "DeviceDefinition.classification", "sliceName": "gmdnTerm", "short": "The GMDN nomenclature that characterizes the device", "min": 1, "max": "1" }, { "id": "DeviceDefinition.classification:gmdnTerm.type", "path": "DeviceDefinition.classification.type", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/GMDNTerm" } }, { "id": "DeviceDefinition.classification:gmdnTerm.justification", "path": "DeviceDefinition.classification.justification", "max": "0" }, { "id": "DeviceDefinition.classification:riskClassification", "path": "DeviceDefinition.classification", "sliceName": "riskClassification", "short": "The risk classification of the product (as seen in the Anvisa's regularization). This field is for query only", "max": "1" }, { "id": "DeviceDefinition.classification:riskClassification.type", "path": "DeviceDefinition.classification.type", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RiskClassification" } }, { "id": "DeviceDefinition.classification:riskClassification.justification", "path": "DeviceDefinition.classification.justification", "max": "0" }, { "id": "DeviceDefinition.classification:anvisaNomenclature", "path": "DeviceDefinition.classification", "sliceName": "anvisaNomenclature", "short": "The Anvisa's nomenclature name (as seen in the Anvisa's regularization). This field is for query only", "max": "1" }, { "id": "DeviceDefinition.classification:anvisaNomenclature.type", "path": "DeviceDefinition.classification.type", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/CodeSystem/AnvisaNomenclature" } }, { "id": "DeviceDefinition.classification:anvisaNomenclature.justification", "path": "DeviceDefinition.classification.justification", "max": "0" }, { "id": "DeviceDefinition.conformsTo", "path": "DeviceDefinition.conformsTo", "max": "0" }, { "id": "DeviceDefinition.hasPart", "path": "DeviceDefinition.hasPart", "max": "0" }, { "id": "DeviceDefinition.packaging", "path": "DeviceDefinition.packaging", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 1 }, { "id": "DeviceDefinition.packaging:primaryPackaging", "path": "DeviceDefinition.packaging", "sliceName": "primaryPackaging", "short": "Primary Packaging. Specifies the Quantity per Primary Packaging", "min": 1, "max": "1" }, { "id": "DeviceDefinition.packaging:primaryPackaging.identifier", "path": "DeviceDefinition.packaging.identifier", "max": "0" }, { "id": "DeviceDefinition.packaging:primaryPackaging.type", "path": "DeviceDefinition.packaging.type", "short": "The identification of the primary packaging", "min": 1, "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/PackagingLevel", "version": "1.0.0", "code": "1", "display": "Primary packaging" } ] }, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PrimaryPackagingLevel" } }, { "id": "DeviceDefinition.packaging:primaryPackaging.count", "path": "DeviceDefinition.packaging.count", "short": "Quantity per Primary Packaging", "min": 1, "minValueInteger": 1, "maxValueInteger": 999999999 }, { "id": "DeviceDefinition.packaging:primaryPackaging.distributor", "path": "DeviceDefinition.packaging.distributor", "max": "0" }, { "id": "DeviceDefinition.packaging:primaryPackaging.udiDeviceIdentifier", "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "max": "0" }, { "id": "DeviceDefinition.packaging:primaryPackaging.packaging", "path": "DeviceDefinition.packaging.packaging", "max": "0" }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging", "path": "DeviceDefinition.packaging", "sliceName": "higherLevelsPackaging", "short": "Identification of packaging beyond the primary packaging" }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.identifier", "path": "DeviceDefinition.packaging.identifier", "max": "0" }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.type", "path": "DeviceDefinition.packaging.type", "short": "The Package Level", "min": 1, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/HigherLevelsPackaging" } }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.count", "path": "DeviceDefinition.packaging.count", "short": "The quantity per packaging", "min": 1, "minValueInteger": 1, "maxValueInteger": 999999999 }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.distributor", "path": "DeviceDefinition.packaging.distributor", "max": "0" }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.udiDeviceIdentifier", "path": "DeviceDefinition.packaging.udiDeviceIdentifier", "short": "The Package UDI-DI", "min": 1, "max": "1" }, { "id": "DeviceDefinition.packaging:higherLevelsPackaging.packaging", "path": "DeviceDefinition.packaging.packaging", "max": "0" }, { "id": "DeviceDefinition.version", "path": "DeviceDefinition.version", "max": "0" }, { "id": "DeviceDefinition.safety", "path": "DeviceDefinition.safety", "short": "The MRI safety status. Specify the level of product safety in an operating magnetic resonance environment", "min": 1, "max": "1", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/MRSafetyStatus" } }, { "id": "DeviceDefinition.shelfLifeStorage", "path": "DeviceDefinition.shelfLifeStorage", "max": "1" }, { "id": "DeviceDefinition.shelfLifeStorage.extension", "path": "DeviceDefinition.shelfLifeStorage.extension", "max": "1" }, { "id": "DeviceDefinition.shelfLifeStorage.extension:specialPrecautionsForStorageDescription", "path": "DeviceDefinition.shelfLifeStorage.extension", "sliceName": "specialPrecautionsForStorageDescription", "short": "Specify storage and/or handling conditions that may directly impact the product's safety and efficacy", "max": "1", "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/SpecialPrecautionsForStorageDescription" ] } ], "isModifier": false }, { "id": "DeviceDefinition.shelfLifeStorage.type", "path": "DeviceDefinition.shelfLifeStorage.type", "max": "0" }, { "id": "DeviceDefinition.shelfLifeStorage.period[x]", "path": "DeviceDefinition.shelfLifeStorage.period[x]", "max": "0" }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage", "max": "0" }, { "id": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text", "path": "DeviceDefinition.shelfLifeStorage.specialPrecautionsForStorage.text", "min": 1 }, { "id": "DeviceDefinition.languageCode", "path": "DeviceDefinition.languageCode", "max": "0" }, { "id": "DeviceDefinition.property", "path": "DeviceDefinition.property", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" } }, { "id": "DeviceDefinition.property:deviceCategory", "path": "DeviceDefinition.property", "sliceName": "deviceCategory", "short": "Specify if the product corresponds to material, implantable material, equipment, implantable equipment, IVD, or SaMD", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:deviceCategory.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "device-category", "display": "Medical Device Category" } ] } }, { "id": "DeviceDefinition.property:deviceCategory.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/DeviceCategory" } }, { "id": "DeviceDefinition.property:singleUse", "path": "DeviceDefinition.property", "sliceName": "singleUse", "short": "Indicates if the device labeled as single-use", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:singleUse.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "single-use", "display": "Device labeled as single-use" } ] } }, { "id": "DeviceDefinition.property:singleUse.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:reusableDevice", "path": "DeviceDefinition.property", "sliceName": "reusableDevice", "short": "Indicates if the device is reusable", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:reusableDevice.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "reusable-device", "display": "Reusable device" } ] } }, { "id": "DeviceDefinition.property:reusableDevice.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles", "path": "DeviceDefinition.property", "sliceName": "recommendedReprocessingCyles", "short": "Specify the number of recommended reprocessing cycles", "max": "1" }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "recommended-reprocessing-cyles", "display": "Number of reprocessing cycles recommended" } ] } }, { "id": "DeviceDefinition.property:recommendedReprocessingCyles.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "Quantity" } ], "minValueQuantity": { "value": 1 }, "maxValueQuantity": { "value": 999999 } }, { "id": "DeviceDefinition.property:labeledAsSterile", "path": "DeviceDefinition.property", "sliceName": "labeledAsSterile", "short": "Indicates if the device is labeled as sterile", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:labeledAsSterile.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "labeled-as-sterile", "display": "Device labeled as sterile" } ] } }, { "id": "DeviceDefinition.property:labeledAsSterile.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:requiresSterilization", "path": "DeviceDefinition.property", "sliceName": "requiresSterilization", "short": "Indicates if the device requires sterilization before use", "max": "1" }, { "id": "DeviceDefinition.property:requiresSterilization.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "requires-sterilization", "display": "Requires sterilization before use" } ] } }, { "id": "DeviceDefinition.property:requiresSterilization.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:sterilizationMethod", "path": "DeviceDefinition.property", "sliceName": "sterilizationMethod", "short": "Sterilization method" }, { "id": "DeviceDefinition.property:sterilizationMethod.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "sterilization-method", "display": "Sterilization Method" } ] } }, { "id": "DeviceDefinition.property:sterilizationMethod.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/SterilizationMethod" } }, { "id": "DeviceDefinition.property:layUse", "path": "DeviceDefinition.property", "sliceName": "layUse", "short": "Indicates if the device can be used by a lay user", "max": "1" }, { "id": "DeviceDefinition.property:layUse.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "lay-use", "display": "Intended for use by a lay user" } ] } }, { "id": "DeviceDefinition.property:layUse.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:incorporatesAi", "path": "DeviceDefinition.property", "sliceName": "incorporatesAi", "short": "Indicates if the product incorporates AI (artificial intelligence) in any device function", "max": "1" }, { "id": "DeviceDefinition.property:incorporatesAi.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "incorporates-ai", "display": "Incorporates Artificial Inteligence into the medical device function" } ] } }, { "id": "DeviceDefinition.property:incorporatesAi.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:combinationProduct", "path": "DeviceDefinition.property", "sliceName": "combinationProduct", "short": "Indicates if the product is associated with any pharmaceutical product that has a secondary function in the device", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:combinationProduct.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "combination-product", "display": "Combination product" } ] } }, { "id": "DeviceDefinition.property:combinationProduct.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes", "path": "DeviceDefinition.property", "sliceName": "clinicallyRelevantSizes", "short": "Specify dimensional characteristics that are relevant for the product's clinical function", "max": "1" }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "clinically-relevant-sizes", "display": "Clinically Relevant Sizes" } ] } }, { "id": "DeviceDefinition.property:clinicallyRelevantSizes.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "string" } ], "maxLength": 5000 }, { "id": "DeviceDefinition.property:batchNumber", "path": "DeviceDefinition.property", "sliceName": "batchNumber", "short": "Indicates the presence of lot or Batch Number", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:batchNumber.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "batch-number", "display": "Lot or Batch Number" } ] } }, { "id": "DeviceDefinition.property:batchNumber.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:serialNumber", "path": "DeviceDefinition.property", "sliceName": "serialNumber", "short": "Indicates the presence of serial number", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:serialNumber.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "serial-number", "display": "Serial Number" } ] } }, { "id": "DeviceDefinition.property:serialNumber.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:expirationDate", "path": "DeviceDefinition.property", "sliceName": "expirationDate", "short": "Indicates the presence of expiration date", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:expirationDate.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "expiration-date", "display": "Expiration date" } ] } }, { "id": "DeviceDefinition.property:expirationDate.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:manufRecondReprocDate", "path": "DeviceDefinition.property", "sliceName": "manufRecondReprocDate", "short": "Indicates the presence of a Manufacture or Refurbishing/Reprocessing date", "min": 1, "max": "1" }, { "id": "DeviceDefinition.property:manufRecondReprocDate.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "manuf-recond-reproc-date", "display": "Manufacture or Refurbishing/Reprocessing date" } ] } }, { "id": "DeviceDefinition.property:manufRecondReprocDate.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:samdReleaseDate", "path": "DeviceDefinition.property", "sliceName": "samdReleaseDate", "short": "Indicates the presence of SaMD release date", "max": "1" }, { "id": "DeviceDefinition.property:samdReleaseDate.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "samd-release-date", "display": "SaMD release date" } ] } }, { "id": "DeviceDefinition.property:samdReleaseDate.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.property:samdVersion", "path": "DeviceDefinition.property", "sliceName": "samdVersion", "short": "Indicates the presence of SaMD version", "max": "1" }, { "id": "DeviceDefinition.property:samdVersion.type", "path": "DeviceDefinition.property.type", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/DeviceProperty", "version": "1.0.0", "code": "samd-version", "display": "SaMD version" } ] } }, { "id": "DeviceDefinition.property:samdVersion.value[x]", "path": "DeviceDefinition.property.value[x]", "type": [ { "code": "boolean" } ] }, { "id": "DeviceDefinition.owner", "path": "DeviceDefinition.owner", "max": "0" }, { "id": "DeviceDefinition.contact", "path": "DeviceDefinition.contact", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "min": 1, "max": "2" }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo", "path": "DeviceDefinition.contact", "sliceName": "urlForAdditionalInfo", "short": "URL for additional information. Fill out whenever the company wants to indicate a URL where additional product information can be found (e.g., company website with product catalog or electronic instructions for use)", "max": "1" }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.system", "path": "DeviceDefinition.contact.system", "min": 1, "fixedCode": "url" }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.value", "path": "DeviceDefinition.contact.value", "min": 1, "maxLength": 5000 }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.use", "path": "DeviceDefinition.contact.use", "max": "0" }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.rank", "path": "DeviceDefinition.contact.rank", "max": "0" }, { "id": "DeviceDefinition.contact:urlForAdditionalInfo.period", "path": "DeviceDefinition.contact.period", "max": "0" }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo", "path": "DeviceDefinition.contact", "sliceName": "manufacCustomerServiceInfo", "short": "Manufacturer’s Customer Service Contact Information (as indicated on the label)", "min": 1, "max": "1" }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.system", "path": "DeviceDefinition.contact.system", "min": 1, "fixedCode": "other" }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.value", "path": "DeviceDefinition.contact.value", "min": 1, "maxLength": 5000 }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.use", "path": "DeviceDefinition.contact.use", "max": "0" }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.rank", "path": "DeviceDefinition.contact.rank", "max": "0" }, { "id": "DeviceDefinition.contact:manufacCustomerServiceInfo.period", "path": "DeviceDefinition.contact.period", "max": "0" }, { "id": "DeviceDefinition.link", "path": "DeviceDefinition.link", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "max": "2" }, { "id": "DeviceDefinition.link:attachedRecord", "path": "DeviceDefinition.link", "sliceName": "attachedRecord", "short": "Another registration to which this record is attached", "max": "1" }, { "id": "DeviceDefinition.link:attachedRecord.relation", "path": "DeviceDefinition.link.relation", "fixedCoding": { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/RelationType", "version": "1.0.0", "code": "attached", "display": "The current registration is being attached to another" }, "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/AttachedRelationType" } }, { "id": "DeviceDefinition.link:previousRecord", "path": "DeviceDefinition.link", "sliceName": "previousRecord", "short": "A previous registration replaced by this record", "max": "1" }, { "id": "DeviceDefinition.link:previousRecord.relation", "path": "DeviceDefinition.link.relation", "binding": { "strength": "required", "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/PreviousRelationType" } }, { "id": "DeviceDefinition.note", "path": "DeviceDefinition.note", "max": "0" }, { "id": "DeviceDefinition.material", "path": "DeviceDefinition.material", "slicing": { "discriminator": [ { "type": "value", "path": "property" } ], "rules": "open" }, "max": "2" }, { "id": "DeviceDefinition.material:biologicMaterial", "path": "DeviceDefinition.material", "sliceName": "biologicMaterial", "short": "Indicates if any component of the product has origins in cells, tissues, or their non-viable derivatives (without metabolism or multiplication capability) or made non-viable", "max": "1" }, { "id": "DeviceDefinition.material:biologicMaterial.substance", "path": "DeviceDefinition.material.substance", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType", "version": "1.0.0", "code": "biologic-material", "display": "Biological tissues/cells or their derivatives" } ] } }, { "id": "DeviceDefinition.material:biologicMaterial.alternate", "path": "DeviceDefinition.material.alternate", "max": "0" }, { "id": "DeviceDefinition.material:biologicMaterial.allergenicIndicator", "path": "DeviceDefinition.material.allergenicIndicator", "max": "0" }, { "id": "DeviceDefinition.material:naturalLatex", "path": "DeviceDefinition.material", "sliceName": "naturalLatex", "short": "Indicates if the device is labeled as \"Contain natural latex. May cause allergy\"", "max": "1" }, { "id": "DeviceDefinition.material:naturalLatex.substance", "path": "DeviceDefinition.material.substance", "fixedCodeableConcept": { "coding": [ { "system": "https://udi.anvisa.gov.br/fhir/CodeSystem/SubstanceType", "version": "1.0.0", "code": "natural-latex", "display": "Natural latex" } ] } }, { "id": "DeviceDefinition.material:naturalLatex.alternate", "path": "DeviceDefinition.material.alternate", "max": "0" }, { "id": "DeviceDefinition.material:naturalLatex.allergenicIndicator", "path": "DeviceDefinition.material.allergenicIndicator", "min": 1, "fixedBoolean": true }, { "id": "DeviceDefinition.productionIdentifierInUDI", "path": "DeviceDefinition.productionIdentifierInUDI", "max": "0" }, { "id": "DeviceDefinition.guideline.extension", "path": "DeviceDefinition.guideline.extension", "max": "1" }, { "id": "DeviceDefinition.guideline.extension:warningDescription", "path": "DeviceDefinition.guideline.extension", "sliceName": "warningDescription", "short": "Additional critical warnings and contraindications for use", "max": "1", "type": [ { "code": "Extension", "profile": [ "https://udi.anvisa.gov.br/fhir/StructureDefinition/WarningDescription" ] } ], "isModifier": false }, { "id": "DeviceDefinition.guideline.useContext", "path": "DeviceDefinition.guideline.useContext", "max": "0" }, { "id": "DeviceDefinition.guideline.usageInstruction", "path": "DeviceDefinition.guideline.usageInstruction", "max": "0" }, { "id": "DeviceDefinition.guideline.relatedArtifact", "path": "DeviceDefinition.guideline.relatedArtifact", "max": "0" }, { "id": "DeviceDefinition.guideline.indication", "path": "DeviceDefinition.guideline.indication", "max": "0" }, { "id": "DeviceDefinition.guideline.contraindication", "path": "DeviceDefinition.guideline.contraindication", "max": "0" }, { "id": "DeviceDefinition.guideline.warning", "path": "DeviceDefinition.guideline.warning", "max": "0" }, { "id": "DeviceDefinition.guideline.intendedUse", "path": "DeviceDefinition.guideline.intendedUse", "max": "0" }, { "id": "DeviceDefinition.correctiveAction", "path": "DeviceDefinition.correctiveAction", "max": "0" }, { "id": "DeviceDefinition.chargeItem", "path": "DeviceDefinition.chargeItem", "max": "0" } ] } }