RDC Interoperability Guide
1.4.0

Device Definition

Official URL: https://roche.com/fhir/iop/StructureDefinition/rdc-DeviceDefinition Version: 1.4.0
Parent:

http://hl7.org/fhir/StructureDefinition/DeviceDefinition

Computable Name:

RdcDeviceDefition

Formal Views of Profile Content

idΣ0..1id
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
textC0..1Narrative
containedC0..*Resource
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
description0..0markdown
identifierΣ C0..0Identifier
partNumber0..0string
manufacturerΣ C0..1Reference(Organization)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
nameΣ1..1string
typeΣ1..1codeBinding
modelNumberΣ1..1string
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
typeΣ1..1CodeableConceptBinding
justification0..0RelatedArtifact
safetyΣ0..0CodeableConcept
shelfLifeStorage0..0ProductShelfLife
languageCode0..0CodeableConcept
ownerC0..0Reference(Organization)
contactC0..0ContactPoint
note0..0Annotation
productionIdentifierInUDI0..0codeBinding

DeviceDefinition
ShortAn instance of a medical-related component of a medical device
Definition

The characteristics, operational status and capabilities of a medical-related component of a medical device.

Cardinality0..*
Comments

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.

Constraints
  • dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    contained.contained.empty()
  • dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
  • dom-3: 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
    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()
  • dom-6: A resource should have narrative for robust management
    text.`div`.exists()
  • dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    contained.meta.security.empty()
Mappings
  • rim: n/a
  • rim: Entity. Role, or Act
  • rim: Entity, Role, or Act
  • w5: administrative.device
DeviceDefinition.id
ShortLogical 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.

Cardinality0..1
Typeid
SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.meta
ShortMetadata 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.

Cardinality0..1
TypeMeta
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.implicitRules
ShortA 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.

Cardinality0..1
Typeuri
ModifierTrue
SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.language
ShortLanguage of the resource content
Definition

The base language in which the resource is written.

Cardinality0..1
Typecode
Binding

IETF language tag for a human language

AllLanguages (required)

Additional bindings
Comments

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).

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.text
ShortText 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.

Cardinality0..1
TypeNarrative
Aliasnarrative, html, xhtml, display
Comments

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.

ConditionsThe cardinality or value of this element may be affected by these constraints: dom-6
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
  • rim: Act.text?
DeviceDefinition.contained
ShortContained, 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.

Cardinality0..*
TypeResource
Aliasinline resources, anonymous resources, contained resources
Comments

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.

ConditionsThe cardinality or value of this element may be affected by these constraints: dom-2, dom-4, dom-3, dom-5
Mappings
  • rim: n/a
  • rim: Entity. Role, or Act
  • rim: N/A
DeviceDefinition.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content
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.

Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.description
ShortAdditional information to describe the device
Definition

Additional information to describe the device.

Cardinality0..0
Typemarkdown
Comments

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/

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.identifier
ShortInstance 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.

Cardinality0..0
TypeIdentifier
SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ident-1: 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
    value.exists()
Mappings
  • rim: n/a
  • v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim: 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]
  • servd: Identifier
  • w5: FiveWs.identifier
DeviceDefinition.udiDeviceIdentifier
ShortUnique 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.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.udiDeviceIdentifier.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
ShortThe 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.

Cardinality1..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.issuer
ShortThe organization that assigns the identifier algorithm
Definition

The organization that assigns the identifier algorithm.

Cardinality1..1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.jurisdiction
ShortThe jurisdiction to which the deviceIdentifier applies
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality1..1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.marketDistribution
ShortIndicates whether and when the device is available on the market
Definition

Indicates where and when the device is available on the market.

Cardinality0..*
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.marketDistribution.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
ShortBegin and end dates for the commercial distribution of the device
Definition

Begin and end dates for the commercial distribution of the device.

Cardinality1..1
TypePeriod
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • per-1: If present, start SHALL have a lower or equal value than end
    start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())
Mappings
  • rim: n/a
  • v2: DR
  • rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
ShortNational state or territory where the device is commercialized
Definition

National state or territory to which the marketDistribution recers, typically where the device is commercialized.

Cardinality1..1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier
ShortRegulatory 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.

Cardinality0..0
TypeBackboneElement
Comments

This should not be used for regulatory authorization numbers which are to be captured elsewhere.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.regulatoryIdentifier.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.regulatoryIdentifier.type
Shortbasic | master | license
Definition

The type of identifier itself.

Cardinality1..1
Typecode
Binding

Device regulatory identifier type.

DeviceDefinitionRegulatoryIdentifierType (required)

Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
ShortThe identifier itself
Definition

The identifier itself.

Cardinality1..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier.issuer
ShortThe organization that issued this identifier
Definition

The organization that issued this identifier.

Cardinality1..1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.regulatoryIdentifier.jurisdiction
ShortThe jurisdiction to which the deviceIdentifier applies
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality1..1
Typeuri
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.partNumber
ShortThe part number or catalog number of the device
Definition

The part number or catalog number of the device.

Cardinality0..0
Typestring
Comments

Alphanumeric Maximum 20.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • w5: FiveWs.what[x]
  • rim: .playedRole[typeCode=MANU].id
DeviceDefinition.manufacturer
ShortName 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.

Cardinality0..1
TypeReference(Organization)
SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))
  • ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
    reference.exists() or identifier.exists() or display.exists() or extension.exists()
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • w5: FiveWs.what[x]
  • rim: .playedRole[typeCode=MANU].scoper.name
DeviceDefinition.deviceName
ShortThe name or names of the device as given by the manufacturer
Definition

The name or names of the device as given by the manufacturer.

Cardinality0..*
TypeBackboneElement
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.deviceName.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.deviceName.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.deviceName.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.deviceName.name
ShortA 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.

Cardinality1..1
Typestring
SummaryTrue
AliasΣ
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.deviceName.type
Shortregistered-name | user-friendly-name | patient-reported-name
Definition

The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName.

Cardinality1..1
Typecode
Binding

The type of name the device is referred by.

DeviceNameType (required)

SummaryTrue
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • w5: FiveWs.what[x]
  • rim: .playedRole[typeCode=MANU].code
DeviceDefinition.modelNumber
ShortThe catalog or model number for the device for example as defined by the manufacturer
Definition

The model number for the device for example as defined by the manufacturer or labeler, or other agency.

Cardinality1..1
Typestring
SummaryTrue
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • w5: FiveWs.what[x]
  • rim: .softwareName (included as part)
DeviceDefinition.classification
ShortWhat kind of device or device system this is
Definition

What kind of device or device system this is.

Cardinality0..1
TypeBackboneElement
SummaryTrue
Comments

In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.classification.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.classification.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.classification.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.classification.type
ShortA classification or risk class of the device model
Definition

A classification or risk class of the device model.

Cardinality1..1
TypeCodeableConcept
Binding

Type of device e.g. according to official classification.

DeviceKind (required)

SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.classification.justification
ShortFurther information qualifying this classification of the device model
Definition

Further information qualifying this classification of the device model.

Cardinality0..0
TypeRelatedArtifact
Comments

Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.conformsTo
ShortIdentifies 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.

Cardinality0..0
TypeBackboneElement
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.conformsTo.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.conformsTo.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.conformsTo.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.conformsTo.category
ShortDescribes the common type of the standard, specification, or formal guidance
Definition

Describes the type of the standard, specification, or formal guidance.

Cardinality0..1
TypeCodeableConcept
Binding

DeviceSpecificationCategory (example)

SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.conformsTo.specification
ShortIdentifies 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.

Cardinality1..1
TypeCodeableConcept
Binding

DeviceSpecificationType (example)

SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.conformsTo.version
ShortThe 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.

Cardinality0..*
Typestring
SummaryTrue
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.conformsTo.source
ShortStandard, 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.

Cardinality0..*
TypeRelatedArtifact
Comments

Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.hasPart
ShortA device, part of the current one
Definition

A device that is part (for example a component) of the present device.

Cardinality0..0
TypeBackboneElement
SummaryTrue
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.hasPart.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.hasPart.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.hasPart.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.hasPart.reference
ShortReference to the part
Definition

Reference to the device that is part of the current device.

Cardinality1..1
TypeReference(DeviceDefinition)
SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))
  • ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
    reference.exists() or identifier.exists() or display.exists() or extension.exists()
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
DeviceDefinition.hasPart.count
ShortNumber of occurrences of the part
Definition

Number of instances of the component device in the current device.

Cardinality0..1
Typeinteger
Comments

32 bit number; for values larger than this, use decimal

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.packaging
ShortInformation 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.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.packaging.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.packaging.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.packaging.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.packaging.identifier
ShortBusiness identifier of the packaged medication
Definition

The business identifier of the packaged medication.

Cardinality0..1
TypeIdentifier
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ident-1: 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
    value.exists()
Mappings
  • rim: n/a
  • v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim: 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]
  • servd: Identifier
DeviceDefinition.packaging.type
ShortA code that defines the specific type of packaging
Definition

A code that defines the specific type of packaging.

Cardinality0..1
TypeCodeableConcept
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.packaging.count
ShortThe number of items contained in the package (devices or sub-packages)
Definition

The number of items contained in the package (devices or sub-packages).

Cardinality0..1
Typeinteger
Comments

32 bit number; for values larger than this, use decimal

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.packaging.distributor
ShortAn organization that distributes the packaged device
Definition

An organization that distributes the packaged device.

Cardinality0..*
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.packaging.distributor.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.packaging.distributor.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.packaging.distributor.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.packaging.distributor.name
ShortDistributor's human-readable name
Definition

Distributor's human-readable name.

Cardinality0..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.packaging.distributor.organizationReference
ShortDistributor as an Organization resource
Definition

Distributor as an Organization resource.

Cardinality0..*
TypeReference(Organization)
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))
  • ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
    reference.exists() or identifier.exists() or display.exists() or extension.exists()
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
DeviceDefinition.packaging.udiDeviceIdentifier
ShortUnique Device Identifier (UDI) Barcode string on the packaging
Definition

Unique Device Identifier (UDI) Barcode string on the packaging.

Cardinality0..*
Typesee (udiDeviceIdentifier)
DeviceDefinition.packaging.packaging
ShortAllows packages within packages
Definition

Allows packages within packages.

Cardinality0..*
Typesee (packaging)
DeviceDefinition.version
ShortThe version of the device or software
Definition

The version of the device or software.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.version.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.version.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.version.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.version.type
ShortThe type of the device version, e.g. manufacturer, approved, internal
Definition

The type of the device version, e.g. manufacturer, approved, internal.

Cardinality0..1
TypeCodeableConcept
AliasΣ
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.version.component
ShortThe 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.

Cardinality0..1
TypeIdentifier
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ident-1: 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
    value.exists()
Mappings
  • rim: n/a
  • v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim: 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]
  • servd: Identifier
  • w5: FiveWs.what[x]
DeviceDefinition.version.value
ShortThe version text
Definition

The version text.

Cardinality1..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.safety
ShortSafety characteristics of the device
Definition

Safety characteristics of the device.

Cardinality0..0
TypeCodeableConcept
Binding

DeviceSafety (example)

SummaryTrue
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.shelfLifeStorage
ShortShelf Life and storage information
Definition

Shelf Life and storage information.

Cardinality0..0
TypeProductShelfLife
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • w5: administrative.medication
DeviceDefinition.languageCode
ShortLanguage 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).

Cardinality0..0
TypeCodeableConcept
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.property
ShortInherent, 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.

Cardinality0..0
TypeBackboneElement
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.property.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.property.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.property.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.property.type
ShortCode that specifies the property being represented
Definition

Code that specifies the property such as a resolution or color being represented.

Cardinality1..1
TypeCodeableConcept
Binding

Device property type.

DeviceType (example)

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.property.value[x]
ShortValue of the property
Definition

The value of the property specified by the associated property.type code.

Cardinality1..1
TypeAttachment | boolean | CodeableConcept | integer | Quantity | Range | string
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.owner
ShortOrganization responsible for device
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Cardinality0..0
TypeReference(Organization)
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1: SHALL have a contained resource if a local reference is provided
    reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))
  • ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
    reference.exists() or identifier.exists() or display.exists() or extension.exists()
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • w5: FiveWs.source
  • rim: .playedRole[typeCode=OWN].scoper
DeviceDefinition.contact
ShortDetails for human/organization for support
Definition

Contact details for an organization or a particular human that is responsible for the device.

Cardinality0..0
TypeContactPoint
Comments

used for troubleshooting etc.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • cpt-2: A system is required if a value is provided.
    value.empty() or system.exists()
Mappings
  • rim: n/a
  • v2: XTN
  • rim: TEL
  • servd: ContactPoint
  • w5: FiveWs.source
  • rim: .scopedRole[typeCode=CON].player
DeviceDefinition.link
ShortAn 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.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.link.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.link.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.link.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.link.relation
ShortThe 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.

Cardinality1..1
TypeCoding
Binding

The type of relation between this and the linked device.

DeviceDefinitionRelationType (extensible)

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • cod-1: 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
    code.exists().not() implies display.exists().not()
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
  • rim: CV
  • orim: fhir:Coding rdfs:subClassOf dt:CDCoding
DeviceDefinition.link.relatedDevice
ShortA reference to the linked device
Definition

A reference to the linked device.

Cardinality1..1
TypeCodeableReference(DeviceDefinition)
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.note
ShortDevice notes and comments
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Cardinality0..0
TypeAnnotation
Comments

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).

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: N/A
  • rim: Act
  • rim: .text
DeviceDefinition.material
ShortA 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.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.material.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.material.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.material.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.material.substance
ShortA 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.

Cardinality1..1
TypeCodeableConcept
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.material.alternate
ShortIndicates an alternative material of the device
Definition

Indicates an alternative material of the device.

Cardinality0..1
Typeboolean
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.material.allergenicIndicator
ShortWhether the substance is a known or suspected allergen
Definition

Whether the substance is a known or suspected allergen.

Cardinality0..1
Typeboolean
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.productionIdentifierInUDI
Shortlot-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.

Cardinality0..0
Typecode
Binding

The production identifier(s) that are expected to appear in the UDI carrier.

DeviceProductionIdentifierInUDI (required)

Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.guideline
ShortInformation 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.

Cardinality0..0
TypeBackboneElement
Comments

For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.guideline.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.guideline.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.guideline.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.guideline.useContext
ShortThe circumstances that form the setting for using the device
Definition

The circumstances that form the setting for using the device.

Cardinality0..*
TypeUsageContext
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.guideline.usageInstruction
ShortDetailed 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.

Cardinality0..1
Typemarkdown
Comments

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/

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.guideline.relatedArtifact
ShortA source of information or reference for this guideline
Definition

A source of information or reference for this guideline.

Cardinality0..*
TypeRelatedArtifact
Comments

Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.guideline.indication
ShortA clinical condition for which the device was designed to be used
Definition

A clinical condition for which the device was designed to be used.

Cardinality0..*
TypeCodeableConcept
Comments

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.guideline.contraindication
ShortA 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.

Cardinality0..*
TypeCodeableConcept
Comments

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.guideline.warning
ShortSpecific 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.

Cardinality0..*
TypeCodeableConcept
Comments

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
DeviceDefinition.guideline.intendedUse
ShortA 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.

Cardinality0..1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.correctiveAction
ShortTracking of latest field safety corrective action
Definition

Tracking of latest field safety corrective action.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.correctiveAction.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.correctiveAction.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.correctiveAction.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.correctiveAction.recall
ShortWhether the corrective action was a recall
Definition

Whether the last corrective action known for this device was a recall.

Cardinality1..1
Typeboolean
Comments

When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.correctiveAction.scope
Shortmodel | 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.

Cardinality0..1
Typecode
Binding

The type or scope of the corrective action.

DeviceCorrectiveActionScope (required)

Comments

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.correctiveAction.period
ShortStart and end dates of the corrective action
Definition

Start and end dates of the corrective action.

Cardinality1..1
TypePeriod
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • per-1: If present, start SHALL have a lower or equal value than end
    start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())
Mappings
  • rim: n/a
  • v2: DR
  • rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
DeviceDefinition.chargeItem
ShortBilling code or reference associated with the device
Definition

Billing code or reference associated with the device.

Cardinality0..0
TypeBackboneElement
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.chargeItem.id
ShortUnique 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.

Cardinality0..1
Typestring
ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1
Mappings
  • rim: n/a
DeviceDefinition.chargeItem.extension
ShortAdditional 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.

Cardinality0..*
TypeExtension
Aliasextensions, user content
Comments

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.

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.chargeItem.modifierExtension
ShortExtensions 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality0..*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
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.

Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
DeviceDefinition.chargeItem.chargeItemCode
ShortThe code or reference for the charge item
Definition

The code or reference for the charge item.

Cardinality1..1
TypeCodeableReference(ChargeItemDefinition)
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
DeviceDefinition.chargeItem.count
ShortCoefficient applicable to the billing code
Definition

Coefficient applicable to the billing code.

Cardinality1..1
TypeQuantity
Comments

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.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • qty-3: If a code for the unit is present, the system SHALL also be present
    code.empty() or system.exists()
Mappings
  • rim: n/a
  • v2: SN (see also Range) or CQ
  • rim: PQ, IVL<PQ>, MO, CO, depending on the values
DeviceDefinition.chargeItem.effectivePeriod
ShortA specific time period in which this charge item applies
Definition

A specific time period in which this charge item applies.

Cardinality0..1
TypePeriod
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • per-1: If present, start SHALL have a lower or equal value than end
    start.hasValue().not() or end.hasValue().not() or (start.lowBoundary() <= end.highBoundary())
Mappings
  • rim: n/a
  • v2: DR
  • rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
DeviceDefinition.chargeItem.useContext
ShortThe context to which this charge item applies
Definition

The context to which this charge item applies.

Cardinality0..*
TypeUsageContext
Constraints
  • ele-1: All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim: n/a
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="rdc-DeviceDefinition" />
<url value="https://roche.com/fhir/iop/StructureDefinition/rdc-DeviceDefinition" />
<name value="RdcDeviceDefition" />
<title value="RDC Device Definition" />
<status value="active" />
<fhirVersion value="5.0.0" />
<kind value="resource" />
<abstract value="false" />
<type value="DeviceDefinition" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" />
<derivation value="constraint" />
<element id="DeviceDefinition.description">
<path value="DeviceDefinition.description" />
<max value="0" />
</element>
<element id="DeviceDefinition.identifier">
<path value="DeviceDefinition.identifier" />
<max value="0" />
</element>
<element id="DeviceDefinition.udiDeviceIdentifier">
<path value="DeviceDefinition.udiDeviceIdentifier" />
<max value="0" />
</element>
<element id="DeviceDefinition.regulatoryIdentifier">
<path value="DeviceDefinition.regulatoryIdentifier" />
<max value="0" />
</element>
<element id="DeviceDefinition.partNumber">
<path value="DeviceDefinition.partNumber" />
<max value="0" />
</element>
<element id="DeviceDefinition.modelNumber">
<path value="DeviceDefinition.modelNumber" />
<min value="1" />
</element>
<element id="DeviceDefinition.classification">
<path value="DeviceDefinition.classification" />
<max value="1" />
</element>
<element id="DeviceDefinition.classification.type">
<path value="DeviceDefinition.classification.type" />
<strength value="required" />
<valueSet value="https://roche.com/fhir/iop/ValueSet/device-kind" />
</binding>
</element>
<element id="DeviceDefinition.classification.justification">
<path value="DeviceDefinition.classification.justification" />
<max value="0" />
</element>
<element id="DeviceDefinition.conformsTo">
<path value="DeviceDefinition.conformsTo" />
<max value="0" />
</element>
<element id="DeviceDefinition.hasPart">
<path value="DeviceDefinition.hasPart" />
<max value="0" />
</element>
<element id="DeviceDefinition.packaging">
<path value="DeviceDefinition.packaging" />
<max value="0" />
</element>
<element id="DeviceDefinition.version">
<path value="DeviceDefinition.version" />
<max value="0" />
</element>
<element id="DeviceDefinition.safety">
<path value="DeviceDefinition.safety" />
<max value="0" />
</element>
<element id="DeviceDefinition.shelfLifeStorage">
<path value="DeviceDefinition.shelfLifeStorage" />
<max value="0" />
</element>
<element id="DeviceDefinition.languageCode">
<path value="DeviceDefinition.languageCode" />
<max value="0" />
</element>
<element id="DeviceDefinition.property">
<path value="DeviceDefinition.property" />
<max value="0" />
</element>
<element id="DeviceDefinition.owner">
<path value="DeviceDefinition.owner" />
<max value="0" />
</element>
<element id="DeviceDefinition.contact">
<path value="DeviceDefinition.contact" />
<max value="0" />
</element>
<element id="DeviceDefinition.link">
<path value="DeviceDefinition.link" />
<max value="0" />
</element>
<element id="DeviceDefinition.note">
<path value="DeviceDefinition.note" />
<max value="0" />
</element>
<element id="DeviceDefinition.material">
<path value="DeviceDefinition.material" />
<max value="0" />
</element>
<element id="DeviceDefinition.productionIdentifierInUDI">
<path value="DeviceDefinition.productionIdentifierInUDI" />
<max value="0" />
</element>
<element id="DeviceDefinition.guideline">
<path value="DeviceDefinition.guideline" />
<max value="0" />
</element>
<element id="DeviceDefinition.correctiveAction">
<path value="DeviceDefinition.correctiveAction" />
<max value="0" />
</element>
<element id="DeviceDefinition.chargeItem">
<path value="DeviceDefinition.chargeItem" />
<max value="0" />
</element>
</differential>
</StructureDefinition>
{
"resourceType": "StructureDefinition",
"id": "rdc-DeviceDefinition",
"url": "https://roche.com/fhir/iop/StructureDefinition/rdc-DeviceDefinition",
"name": "RdcDeviceDefition",
"title": "RDC Device Definition",
"status": "active",
"fhirVersion": "5.0.0",
"kind": "resource",
"abstract": false,
"type": "DeviceDefinition",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"derivation": "constraint",
"element": [
{
"id": "DeviceDefinition.description",
"path": "DeviceDefinition.description",
"max": "0"
},
{
"id": "DeviceDefinition.identifier",
"path": "DeviceDefinition.identifier",
"max": "0"
},
{
"id": "DeviceDefinition.udiDeviceIdentifier",
"path": "DeviceDefinition.udiDeviceIdentifier",
"max": "0"
},
{
"id": "DeviceDefinition.regulatoryIdentifier",
"path": "DeviceDefinition.regulatoryIdentifier",
"max": "0"
},
{
"id": "DeviceDefinition.partNumber",
"path": "DeviceDefinition.partNumber",
"max": "0"
},
{
"id": "DeviceDefinition.modelNumber",
"path": "DeviceDefinition.modelNumber",
"min": 1
},
{
"id": "DeviceDefinition.classification",
"path": "DeviceDefinition.classification",
"max": "1"
},
{
"id": "DeviceDefinition.classification.type",
"path": "DeviceDefinition.classification.type",
"binding": {
"strength": "required",
"valueSet": "https://roche.com/fhir/iop/ValueSet/device-kind"
}
},
{
"id": "DeviceDefinition.classification.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",
"max": "0"
},
{
"id": "DeviceDefinition.version",
"path": "DeviceDefinition.version",
"max": "0"
},
{
"id": "DeviceDefinition.safety",
"path": "DeviceDefinition.safety",
"max": "0"
},
{
"id": "DeviceDefinition.shelfLifeStorage",
"path": "DeviceDefinition.shelfLifeStorage",
"max": "0"
},
{
"id": "DeviceDefinition.languageCode",
"path": "DeviceDefinition.languageCode",
"max": "0"
},
{
"id": "DeviceDefinition.property",
"path": "DeviceDefinition.property",
"max": "0"
},
{
"id": "DeviceDefinition.owner",
"path": "DeviceDefinition.owner",
"max": "0"
},
{
"id": "DeviceDefinition.contact",
"path": "DeviceDefinition.contact",
"max": "0"
},
{
"id": "DeviceDefinition.link",
"path": "DeviceDefinition.link",
"max": "0"
},
{
"id": "DeviceDefinition.note",
"path": "DeviceDefinition.note",
"max": "0"
},
{
"id": "DeviceDefinition.material",
"path": "DeviceDefinition.material",
"max": "0"
},
{
"id": "DeviceDefinition.productionIdentifierInUDI",
"path": "DeviceDefinition.productionIdentifierInUDI",
"max": "0"
},
{
"id": "DeviceDefinition.guideline",
"path": "DeviceDefinition.guideline",
"max": "0"
},
{
"id": "DeviceDefinition.correctiveAction",
"path": "DeviceDefinition.correctiveAction",
"max": "0"
},
{
"id": "DeviceDefinition.chargeItem",
"path": "DeviceDefinition.chargeItem",
"max": "0"
}
]
}
}

Referenced in the following data flows

Resource examples