FHIR Extensions Pack
5.3.0-ballot - (September 2025 Ballot) International flag

This page is part of the FHIR Core Extensions Registry (v5.3.0-ballot: Release 5.3) based on FHIR (HL7® FHIR® Standard) v5.0.0. This version is a pre-release. The current official version is 5.2.0. For a full list of available versions, see the Directory of published versions

Extension: Device ConformsTo

Official URL: http://hl7.org/fhir/StructureDefinition/device-conformsTo Version: 5.3.0-ballot
Standards status: Trial-use Maturity Level: 1 Responsible: HL7 International / Orders and Observations Computable Name: DeviceConformsTo

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.

Context of Use

This extension may be used on the following element(s)

Usage info

Usages:

  • This Extension is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Changes since version 5.2.0:

  • New Content

    • Formal Views of Extension Content

    Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

    This structure is derived from Extension

    Summary

    Complex Extension: 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.

    • category: CodeableConcept: Describes the type of the standard, specification, or formal guidance.
    • specification: CodeableConcept: Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
    • version: string: 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.
    • source: RelatedArtifact: Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.

    Maturity: 1

    This structure is derived from Extension

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Extension 0..* Extension Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    ... Slices for extension Content/Rules for all slices
    .... extension:category 0..1 Extension Describes the common type of the standard, specification, or formal guidance
    ..... extension 0..0
    ..... url 1..1 uri "category"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationCategory (example)
    .... extension:specification 1..1 Extension Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    ..... extension 0..0
    ..... url 1..1 uri "specification"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationType (example)
    .... extension:version 0..* Extension The specific form or variant of the standard, specification or formal guidance
    ..... extension 0..0
    ..... url 1..1 uri "version"
    ..... value[x] 0..1 string Value of extension
    .... extension:source 0..* Extension Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
    ..... extension 0..0
    ..... url 1..1 uri "source"
    ..... value[x] 0..1 RelatedArtifact Value of extension
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/device-conformsTo"
    ... value[x] 0..0

    doco Documentation for this format
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Extension 0..* Extension Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    ... id 0..1 id Unique id for inter-element referencing
    ... Slices for extension 1..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... extension:category 0..1 Extension Describes the common type of the standard, specification, or formal guidance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "category"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationCategory (example)
    .... extension:specification 1..1 Extension Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "specification"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationType (example)
    .... extension:version 0..* Extension The specific form or variant of the standard, specification or formal guidance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "version"
    ..... value[x] 0..1 string Value of extension
    .... extension:source 0..* Extension Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "source"
    ..... value[x] 0..1 RelatedArtifact Value of extension
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/device-conformsTo"

    doco Documentation for this format

    This structure is derived from Extension

    Summary

    Complex Extension: 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.

    • category: CodeableConcept: Describes the type of the standard, specification, or formal guidance.
    • specification: CodeableConcept: Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
    • version: string: 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.
    • source: RelatedArtifact: Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.

    Maturity: 1

    Differential View

    This structure is derived from Extension

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Extension 0..* Extension Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    ... Slices for extension Content/Rules for all slices
    .... extension:category 0..1 Extension Describes the common type of the standard, specification, or formal guidance
    ..... extension 0..0
    ..... url 1..1 uri "category"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationCategory (example)
    .... extension:specification 1..1 Extension Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    ..... extension 0..0
    ..... url 1..1 uri "specification"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationType (example)
    .... extension:version 0..* Extension The specific form or variant of the standard, specification or formal guidance
    ..... extension 0..0
    ..... url 1..1 uri "version"
    ..... value[x] 0..1 string Value of extension
    .... extension:source 0..* Extension Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
    ..... extension 0..0
    ..... url 1..1 uri "source"
    ..... value[x] 0..1 RelatedArtifact Value of extension
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/device-conformsTo"
    ... value[x] 0..0

    doco Documentation for this format

    Snapshot View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Extension 0..* Extension Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    ... id 0..1 id Unique id for inter-element referencing
    ... Slices for extension 1..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... extension:category 0..1 Extension Describes the common type of the standard, specification, or formal guidance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "category"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationCategory (example)
    .... extension:specification 1..1 Extension Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "specification"
    ..... value[x] 0..1 CodeableConcept Value of extension
    Binding: DeviceSpecificationType (example)
    .... extension:version 0..* Extension The specific form or variant of the standard, specification or formal guidance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "version"
    ..... value[x] 0..1 string Value of extension
    .... extension:source 0..* Extension Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
    ..... id 0..1 id Unique id for inter-element referencing
    ..... extension 0..0
    ..... url 1..1 uri "source"
    ..... value[x] 0..1 RelatedArtifact Value of extension
    ... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/device-conformsTo"

    doco Documentation for this format

     

    Other representations of profile: CSV, Excel, Schematron

    Terminology Bindings

    PathConformanceValueSetURI
    Extension.extension:category.value[x]exampleDeviceSpecificationCategory
    http://hl7.org/fhir/ValueSet/device-specification-category
    From the FHIR Standard
    Extension.extension:specification.value[x]exampleDeviceSpecificationType
    http://hl7.org/fhir/ValueSet/device-specification-type
    From the FHIR Standard

    Constraints

    IdGradePath(s)DetailsRequirements
    ele-1error**ALL** elementsAll FHIR elements must have a @value or children
    : hasValue() or (children().count() > id.count())
    ext-1error**ALL** extensionsMust have either extensions or value[x], not both
    : extension.exists() != value.exists()

    R4B

    The extension is unchanged in R4B

    R4

    The extension is unchanged in R4

    R3

    The extension is represented a little differently in R3:

    • Replace the type RelatedArtifact with a set of extensions for the content of the type along with the _datatype extension
    • Note: Extensions that have been modified for R3 are still draft while real-world experience is collected
    Name Flags Card. Type Description & Constraints      Filter: Filters doco
    . . Extension 0 .. * Extension Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    . . . Slices for extension Content/Rules for all slices
    . . . . extension:category 0..1 Extension Describes the common type of the standard, specification, or formal guidance
    . . . . . extension 0 .. 0
    . . . . . url 1 .. 1 uri "category"
    . . . . . value[x] 0 .. 1 CodeableConcept Value of extension
    Binding: DeviceSpecificationCategory ( example )
    . . . . extension:specification 1..1 Extension Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    . . . . . extension 0 .. 0
    . . . . . url 1 .. 1 uri "specification"
    . . . . . value[x] 0 .. 1 CodeableConcept Value of extension
    Binding: DeviceSpecificationType ( example )
    . . . . extension:version 0..* Extension The specific form or variant of the standard, specification or formal guidance
    . . . . . extension 0 .. 0
    . . . . . url 1 .. 1 uri "version"
    . . . . . value[x] 0 .. 1 string Value of extension
    . . . . extension:source 0..* Extension Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
    . . . . . Slices for extension 0 ..* Extension Extension
    Slice: Unordered, Open by value:url
    . . . . . . extension:_datatype 1..1 (Complex) DataType name 'RelatedArtifact' from R5
    URL: http://hl7.org/fhir/StructureDefinition/_datatype
    . . . . . . . value[x] 1.. 1 string Value of extension
    Fixed Value: RelatedArtifact
    . . . . . . extension:type 1..1 Extension documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "type"
    . . . . . . . value[x] 1.. 1 code Value of extension
    Binding: RelatedArtifactType ( required ) : The type of relationship to the related artifact.
    . . . . . . extension:classifier 0..* Extension Additional classifiers
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "classifier"
    . . . . . . . value[x] 1.. 1 CodeableConcept Value of extension
    Binding: CitationArtifactClassifier ( example ) : Additional classifiers for the related artifact.
    . . . . . . extension:label 0..1 Extension Short label
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "label"
    . . . . . . . value[x] 1.. 1 string Value of extension
    . . . . . . extension:display 0..1 Extension Brief description of the related artifact
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "display"
    . . . . . . . value[x] 1.. 1 string Value of extension
    . . . . . . extension:citation 0..1 Extension Bibliographic citation for the artifact
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "citation"
    . . . . . . . value[x] 1.. 1 markdown Value of extension
    . . . . . . extension:document 0..1 Extension What document is being referenced
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "document"
    . . . . . . . value[x] 1.. 1 Attachment Value of extension
    . . . . . . extension:resource 0..1 Extension What artifact is being referenced
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "resource"
    . . . . . . . value[x] 1.. 1 uri Value of extension
    . . . . . . extension:resourceReference 0..1 Extension What artifact, if not a conformance resource
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "resourceReference"
    . . . . . . . value[x] 1.. 1 Reference ( Resource ) Value of extension
    . . . . . . extension:publicationStatus 0..1 Extension draft | active | retired | unknown
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "publicationStatus"
    . . . . . . . value[x] 1.. 1 code Value of extension
    Binding: PublicationStatus ( required ) : Publication status of an artifact being referred to.
    . . . . . . extension:publicationDate 0..1 Extension Date of publication of the artifact being referred to
    . . . . . . . extension 0 .. 0
    . . . . . . . url 1 .. 1 uri "publicationDate"
    . . . . . . . value[x] 1.. 1 date Value of extension
    . . . . . url 1 .. 1 uri "source"
    . . . . . value[x] 0 .. 0
    . . . url 1 .. 1 uri "http://hl7.org/fhir/StructureDefinition/device-conformsTo"
    . . . value[x] 0 .. 0

    doco Documentation for this format

    Search Parameters for this Extension

    (none found)