Extensions for Using Data Elements from FHIR R5 in FHIR R4
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Extensions for Using Data Elements from FHIR R5 in FHIR R4 - Downloaded Version null See the Directory of published versions

Resource Profile: Profile_R5_DeviceDefinition_R4 - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 0

Definitions for the profile-DeviceDefinition resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceDefinition
Definition

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

ShortAn instance of a medical-related component of a medical device
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.

Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. DeviceDefinition.implicitRules
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.

ShortA set of rules under which this content was created
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 it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DeviceDefinition.extension
Definition

An Extension


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 manageable, 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.

ShortExtensionAdditional content defined by implementations
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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
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())
SlicingThis element introduces a set of slices on DeviceDefinition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. DeviceDefinition.extension:description
    Slice Namedescription
    Definition

    R5: DeviceDefinition.description (new:markdown)

    ShortR5: Additional information to describe the device (new)
    Comments

    Element DeviceDefinition.description has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.description has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.description: http://hl7.org/fhir/StructureDefinition/artifact-description.

    Control0..1
    TypeExtension(Artifact Description) (Extension Type: markdown)
    Is Modifierfalse
    Summaryfalse
    Invariantsele-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())
    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())
    8. DeviceDefinition.extension:regulatoryIdentifier
    Slice NameregulatoryIdentifier
    Definition

    R5: DeviceDefinition.regulatoryIdentifier (new:BackboneElement)

    ShortR5: Regulatory identifier(s) associated with this device (new)
    Comments

    Element DeviceDefinition.regulatoryIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.regulatoryIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This should not be used for regulatory authorization numbers which are to be captured elsewhere.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Regulatory identifier(s) associated with this device (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    10. DeviceDefinition.extension:partNumber
    Slice NamepartNumber
    Definition

    R5: DeviceDefinition.partNumber (new:string)

    ShortR5: The part number or catalog number of the device (new)
    Comments

    Element DeviceDefinition.partNumber has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.partNumber has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Alphanumeric Maximum 20.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: The part number or catalog number of the device (new)) (Extension Type: string)
    Is Modifierfalse
    Summaryfalse
    Invariantsele-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())
    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())
    12. DeviceDefinition.extension:classification
    Slice Nameclassification
    Definition

    R5: DeviceDefinition.classification (new:BackboneElement)

    ShortR5: What kind of device or device system this is (new)
    Comments

    Element DeviceDefinition.classification has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.classification has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: What kind of device or device system this is (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    14. DeviceDefinition.extension:hasPart
    Slice NamehasPart
    Definition

    R5: DeviceDefinition.hasPart (new:BackboneElement)

    ShortR5: A device, part of the current one (new)
    Comments

    Element DeviceDefinition.hasPart has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.hasPart has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: A device, part of the current one (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    16. DeviceDefinition.extension:packaging
    Slice Namepackaging
    Definition

    R5: DeviceDefinition.packaging (new:BackboneElement)

    ShortR5: Information about the packaging of the device, i.e. how the device is packaged (new)
    Comments

    Element DeviceDefinition.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    18. DeviceDefinition.extension:udiDeviceIdentifier
    Slice NameudiDeviceIdentifier
    Definition

    R5: DeviceDefinition.packaging.udiDeviceIdentifier (new:DeviceDefinition.udiDeviceIdentifier)

    ShortR5: Unique Device Identifier (UDI) Barcode string on the packaging (new)
    Comments

    Element DeviceDefinition.packaging.udiDeviceIdentifier is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.udiDeviceIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.udiDeviceIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: udiDeviceIdentifier) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    20. DeviceDefinition.extension:packaging
    Slice Namepackaging
    Definition

    R5: DeviceDefinition.packaging.packaging (new:DeviceDefinition.packaging)

    ShortR5: Allows packages within packages (new)
    Comments

    Element DeviceDefinition.packaging.packaging is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    22. DeviceDefinition.extension:link
    Slice Namelink
    Definition

    R5: DeviceDefinition.link (new:BackboneElement)

    ShortR5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)
    Comments

    Element DeviceDefinition.link has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.link has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    24. DeviceDefinition.extension:productionIdentifierInUDI
    Slice NameproductionIdentifierInUDI
    Definition

    R5: DeviceDefinition.productionIdentifierInUDI (new:code)

    ShortR5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)
    Comments

    Element DeviceDefinition.productionIdentifierInUDI has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.productionIdentifierInUDI has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)) (Extension Type: code)
    Is Modifierfalse
    Summaryfalse
    Invariantsele-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())
    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())
    26. DeviceDefinition.extension:guideline
    Slice Nameguideline
    Definition

    R5: DeviceDefinition.guideline (new:BackboneElement)

    ShortR5: Information aimed at providing directions for the usage of this model of device (new)
    Comments

    Element DeviceDefinition.guideline has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.guideline has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Information aimed at providing directions for the usage of this model of device (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    28. DeviceDefinition.extension:correctiveAction
    Slice NamecorrectiveAction
    Definition

    R5: DeviceDefinition.correctiveAction (new:BackboneElement)

    ShortR5: Tracking of latest field safety corrective action (new)
    Comments

    Element DeviceDefinition.correctiveAction has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.correctiveAction has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Tracking of latest field safety corrective action (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    30. DeviceDefinition.extension:chargeItem
    Slice NamechargeItem
    Definition

    R5: DeviceDefinition.chargeItem (new:BackboneElement)

    ShortR5: Billing code or reference associated with the device (new)
    Comments

    Element DeviceDefinition.chargeItem has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.chargeItem has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(R5: Billing code or reference associated with the device (new)) (Complex Extension)
    Is Modifierfalse
    Invariantsele-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())
    32. DeviceDefinition.modifierExtension
    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 manageable, 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).

    ShortExtensions that cannot be ignored
    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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Summaryfalse
    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.

    Alternate Namesextensions, user content
    Invariantsele-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())
    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())

    Guidance on how to interpret the contents of this table can be foundhere

    0. DeviceDefinition
    2. DeviceDefinition.extension
    Control0..*
    SlicingThis element introduces a set of slices on DeviceDefinition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 4. DeviceDefinition.extension:description
      Slice Namedescription
      Definition

      R5: DeviceDefinition.description (new:markdown)

      ShortR5: Additional information to describe the device (new)
      Comments

      Element DeviceDefinition.description has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.description has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.description: http://hl7.org/fhir/StructureDefinition/artifact-description.

      Control0..1
      TypeExtension(Artifact Description) (Extension Type: markdown)
      6. DeviceDefinition.extension:regulatoryIdentifier
      Slice NameregulatoryIdentifier
      Definition

      R5: DeviceDefinition.regulatoryIdentifier (new:BackboneElement)

      ShortR5: Regulatory identifier(s) associated with this device (new)
      Comments

      Element DeviceDefinition.regulatoryIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.regulatoryIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This should not be used for regulatory authorization numbers which are to be captured elsewhere.

      Control0..*
      TypeExtension(R5: Regulatory identifier(s) associated with this device (new)) (Complex Extension)
      8. DeviceDefinition.extension:partNumber
      Slice NamepartNumber
      Definition

      R5: DeviceDefinition.partNumber (new:string)

      ShortR5: The part number or catalog number of the device (new)
      Comments

      Element DeviceDefinition.partNumber has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.partNumber has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Alphanumeric Maximum 20.

      Control0..1
      TypeExtension(R5: The part number or catalog number of the device (new)) (Extension Type: string)
      10. DeviceDefinition.extension:classification
      Slice Nameclassification
      Definition

      R5: DeviceDefinition.classification (new:BackboneElement)

      ShortR5: What kind of device or device system this is (new)
      Comments

      Element DeviceDefinition.classification has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.classification has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

      Control0..*
      TypeExtension(R5: What kind of device or device system this is (new)) (Complex Extension)
      12. DeviceDefinition.extension:hasPart
      Slice NamehasPart
      Definition

      R5: DeviceDefinition.hasPart (new:BackboneElement)

      ShortR5: A device, part of the current one (new)
      Comments

      Element DeviceDefinition.hasPart has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.hasPart has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: A device, part of the current one (new)) (Complex Extension)
      14. DeviceDefinition.extension:packaging
      Slice Namepackaging
      Definition

      R5: DeviceDefinition.packaging (new:BackboneElement)

      ShortR5: Information about the packaging of the device, i.e. how the device is packaged (new)
      Comments

      Element DeviceDefinition.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
      16. DeviceDefinition.extension:udiDeviceIdentifier
      Slice NameudiDeviceIdentifier
      Definition

      R5: DeviceDefinition.packaging.udiDeviceIdentifier (new:DeviceDefinition.udiDeviceIdentifier)

      ShortR5: Unique Device Identifier (UDI) Barcode string on the packaging (new)
      Comments

      Element DeviceDefinition.packaging.udiDeviceIdentifier is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.udiDeviceIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.udiDeviceIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: udiDeviceIdentifier) (Complex Extension)
      18. DeviceDefinition.extension:packaging
      Slice Namepackaging
      Definition

      R5: DeviceDefinition.packaging.packaging (new:DeviceDefinition.packaging)

      ShortR5: Allows packages within packages (new)
      Comments

      Element DeviceDefinition.packaging.packaging is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
      20. DeviceDefinition.extension:link
      Slice Namelink
      Definition

      R5: DeviceDefinition.link (new:BackboneElement)

      ShortR5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)
      Comments

      Element DeviceDefinition.link has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.link has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)) (Complex Extension)
      22. DeviceDefinition.extension:productionIdentifierInUDI
      Slice NameproductionIdentifierInUDI
      Definition

      R5: DeviceDefinition.productionIdentifierInUDI (new:code)

      ShortR5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)
      Comments

      Element DeviceDefinition.productionIdentifierInUDI has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.productionIdentifierInUDI has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)) (Extension Type: code)
      24. DeviceDefinition.extension:guideline
      Slice Nameguideline
      Definition

      R5: DeviceDefinition.guideline (new:BackboneElement)

      ShortR5: Information aimed at providing directions for the usage of this model of device (new)
      Comments

      Element DeviceDefinition.guideline has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.guideline has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

      Control0..1
      TypeExtension(R5: Information aimed at providing directions for the usage of this model of device (new)) (Complex Extension)
      26. DeviceDefinition.extension:correctiveAction
      Slice NamecorrectiveAction
      Definition

      R5: DeviceDefinition.correctiveAction (new:BackboneElement)

      ShortR5: Tracking of latest field safety corrective action (new)
      Comments

      Element DeviceDefinition.correctiveAction has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.correctiveAction has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..1
      TypeExtension(R5: Tracking of latest field safety corrective action (new)) (Complex Extension)
      28. DeviceDefinition.extension:chargeItem
      Slice NamechargeItem
      Definition

      R5: DeviceDefinition.chargeItem (new:BackboneElement)

      ShortR5: Billing code or reference associated with the device (new)
      Comments

      Element DeviceDefinition.chargeItem has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.chargeItem has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

      Control0..*
      TypeExtension(R5: Billing code or reference associated with the device (new)) (Complex Extension)
      30. DeviceDefinition.udiDeviceIdentifier
      32. DeviceDefinition.udiDeviceIdentifier.extension
      Control0..*
      SlicingThis element introduces a set of slices on DeviceDefinition.udiDeviceIdentifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 34. DeviceDefinition.udiDeviceIdentifier.extension:marketDistribution
        Slice NamemarketDistribution
        Definition

        R5: DeviceDefinition.udiDeviceIdentifier.marketDistribution (new:BackboneElement)

        ShortR5: Indicates whether and when the device is available on the market (new)
        Comments

        Element DeviceDefinition.udiDeviceIdentifier.marketDistribution has a context of DeviceDefinition.udiDeviceIdentifier based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.udiDeviceIdentifier.marketDistribution has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

        Control0..*
        TypeExtension(R5: Indicates whether and when the device is available on the market (new)) (Complex Extension)
        36. DeviceDefinition.specialization
        38. DeviceDefinition.specialization.extension
        Control0..*
        SlicingThis element introduces a set of slices on DeviceDefinition.specialization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 40. DeviceDefinition.specialization.extension:conformsTo
          Slice NameconformsTo
          Definition

          R5: DeviceDefinition.conformsTo

          ShortR5: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
          Comments

          Element DeviceDefinition.conformsTo is mapped to FHIR R4 element DeviceDefinition.specialization as Equivalent. An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.conformsTo: http://hl7.org/fhir/StructureDefinition/device-conformsTo.

          Control0..*
          TypeExtension(http://hl7.org/fhir/StructureDefinition/device-conformsTo)
          42. DeviceDefinition.version
          NoteThis is a business version Id, not a resource version Id (see discussion)
          44. DeviceDefinition.version.extension
          Control1..*
          SlicingThis element introduces a set of slices on DeviceDefinition.version.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 46. DeviceDefinition.version.extension:type
            Slice Nametype
            Definition

            R5: DeviceDefinition.version.type (new:CodeableConcept)

            ShortR5: The type of the device version, e.g. manufacturer, approved, internal (new)
            Comments

            Element DeviceDefinition.version.type has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

            Control0..1
            TypeExtension(R5: The type of the device version, e.g. manufacturer, approved, internal (new)) (Extension Type: CodeableConcept)
            48. DeviceDefinition.version.extension:component
            Slice Namecomponent
            Definition

            R5: DeviceDefinition.version.component (new:Identifier)

            ShortR5: The hardware or software module of the device to which the version applies (new)
            Comments

            Element DeviceDefinition.version.component has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.component has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). 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.

            Control0..1
            TypeExtension(R5: The hardware or software module of the device to which the version applies (new)) (Extension Type: Identifier)
            50. DeviceDefinition.version.extension:value
            Slice Namevalue
            Definition

            R5: DeviceDefinition.version.value (new:string)

            ShortR5: The version text (new)
            Comments

            Element DeviceDefinition.version.value has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.value has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

            Control1..1
            TypeExtension(R5: The version text (new)) (Extension Type: string)
            52. DeviceDefinition.property
            54. DeviceDefinition.property.extension
            Control1..*
            SlicingThis element introduces a set of slices on DeviceDefinition.property.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 56. DeviceDefinition.property.extension:value
              Slice Namevalue
              Definition

              R5: DeviceDefinition.property.value[x] additional types (string, boolean, integer, Range, Attachment)

              ShortR5: Value of the property additional types
              Comments

              Element DeviceDefinition.property.value[x] is mapped to FHIR R4 element DeviceDefinition.property.valueQuantity as RelatedTo. Element DeviceDefinition.property.value[x] is mapped to FHIR R4 element DeviceDefinition.property.valueCode as RelatedTo. The mappings for DeviceDefinition.property.value[x] do not cover the following types: Attachment, boolean, integer, Range, string. 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.

              Control1..1
              TypeExtension(R5: Value of the property additional types) (Extension Type: Choice of: string, boolean, integer, Range, Attachment)
              58. DeviceDefinition.contact
              60. DeviceDefinition.contact.extension
              Control0..*
              SlicingThis element introduces a set of slices on DeviceDefinition.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 62. DeviceDefinition.contact.extension:contact
                Slice Namecontact
                Definition

                R5: DeviceDefinition.contact

                ShortR5: contact
                Comments

                Element DeviceDefinition.contact is mapped to FHIR R4 element DeviceDefinition.contact as Equivalent. An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.contact: http://hl7.org/fhir/StructureDefinition/artifact-contact. used for troubleshooting etc.

                Control0..*
                TypeExtension(Artifact Contact) (Extension Type: ContactDetail)

                Guidance on how to interpret the contents of this table can be foundhere

                0. DeviceDefinition
                Definition

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

                ShortAn instance of a medical-related component of a medical device
                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.

                Control0..*
                Is Modifierfalse
                Summaryfalse
                Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                dom-6: A resource should have narrative for robust management (text.`div`.exists())
                2. DeviceDefinition.id
                Definition

                The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                ShortLogical id of this artifact
                Comments

                The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                Control0..1
                Typeid
                Is Modifierfalse
                Summarytrue
                4. DeviceDefinition.meta
                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.

                ShortMetadata about the resource
                Control0..1
                TypeMeta
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                6. DeviceDefinition.implicitRules
                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.

                ShortA set of rules under which this content was created
                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 it's narrative along with other profiles, value sets, etc.

                Control0..1
                Typeuri
                Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                8. DeviceDefinition.language
                Definition

                The base language in which the resource is written.

                ShortLanguage of the resource content
                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).

                Control0..1
                BindingThe codes SHOULD be taken from CommonLanguages .
                (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

                A human language.

                Additional BindingsPurpose
                AllLanguagesMax Binding
                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                10. DeviceDefinition.text
                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.

                ShortText summary of the resource, for human interpretation
                Comments

                Contained resources do not have 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.

                Control0..1
                TypeNarrative
                Is Modifierfalse
                Summaryfalse
                Alternate Namesnarrative, html, xhtml, display
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                12. DeviceDefinition.contained
                Definition

                These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                ShortContained, inline 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.

                Control0..*
                TypeResource
                Is Modifierfalse
                Summaryfalse
                Alternate Namesinline resources, anonymous resources, contained resources
                14. DeviceDefinition.extension
                Definition

                An Extension

                ShortExtension
                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Invariantsele-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())
                SlicingThis element introduces a set of slices on DeviceDefinition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 16. DeviceDefinition.extension:description
                  Slice Namedescription
                  Definition

                  R5: DeviceDefinition.description (new:markdown)

                  ShortR5: Additional information to describe the device (new)
                  Comments

                  Element DeviceDefinition.description has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.description has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.description: http://hl7.org/fhir/StructureDefinition/artifact-description.

                  Control0..1
                  TypeExtension(Artifact Description) (Extension Type: markdown)
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-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())
                  18. DeviceDefinition.extension:regulatoryIdentifier
                  Slice NameregulatoryIdentifier
                  Definition

                  R5: DeviceDefinition.regulatoryIdentifier (new:BackboneElement)

                  ShortR5: Regulatory identifier(s) associated with this device (new)
                  Comments

                  Element DeviceDefinition.regulatoryIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.regulatoryIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This should not be used for regulatory authorization numbers which are to be captured elsewhere.

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Regulatory identifier(s) associated with this device (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  20. DeviceDefinition.extension:partNumber
                  Slice NamepartNumber
                  Definition

                  R5: DeviceDefinition.partNumber (new:string)

                  ShortR5: The part number or catalog number of the device (new)
                  Comments

                  Element DeviceDefinition.partNumber has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.partNumber has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Alphanumeric Maximum 20.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: The part number or catalog number of the device (new)) (Extension Type: string)
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-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())
                  22. DeviceDefinition.extension:classification
                  Slice Nameclassification
                  Definition

                  R5: DeviceDefinition.classification (new:BackboneElement)

                  ShortR5: What kind of device or device system this is (new)
                  Comments

                  Element DeviceDefinition.classification has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.classification has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: What kind of device or device system this is (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  24. DeviceDefinition.extension:hasPart
                  Slice NamehasPart
                  Definition

                  R5: DeviceDefinition.hasPart (new:BackboneElement)

                  ShortR5: A device, part of the current one (new)
                  Comments

                  Element DeviceDefinition.hasPart has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.hasPart has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: A device, part of the current one (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  26. DeviceDefinition.extension:packaging
                  Slice Namepackaging
                  Definition

                  R5: DeviceDefinition.packaging (new:BackboneElement)

                  ShortR5: Information about the packaging of the device, i.e. how the device is packaged (new)
                  Comments

                  Element DeviceDefinition.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  28. DeviceDefinition.extension:udiDeviceIdentifier
                  Slice NameudiDeviceIdentifier
                  Definition

                  R5: DeviceDefinition.packaging.udiDeviceIdentifier (new:DeviceDefinition.udiDeviceIdentifier)

                  ShortR5: Unique Device Identifier (UDI) Barcode string on the packaging (new)
                  Comments

                  Element DeviceDefinition.packaging.udiDeviceIdentifier is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.udiDeviceIdentifier has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.udiDeviceIdentifier has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: udiDeviceIdentifier) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  30. DeviceDefinition.extension:packaging
                  Slice Namepackaging
                  Definition

                  R5: DeviceDefinition.packaging.packaging (new:DeviceDefinition.packaging)

                  ShortR5: Allows packages within packages (new)
                  Comments

                  Element DeviceDefinition.packaging.packaging is part of an existing definition because parent element DeviceDefinition.packaging requires a cross-version extension. Element DeviceDefinition.packaging.packaging has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.packaging.packaging has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Information about the packaging of the device, i.e. how the device is packaged (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  32. DeviceDefinition.extension:link
                  Slice Namelink
                  Definition

                  R5: DeviceDefinition.link (new:BackboneElement)

                  ShortR5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)
                  Comments

                  Element DeviceDefinition.link has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.link has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  34. DeviceDefinition.extension:productionIdentifierInUDI
                  Slice NameproductionIdentifierInUDI
                  Definition

                  R5: DeviceDefinition.productionIdentifierInUDI (new:code)

                  ShortR5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)
                  Comments

                  Element DeviceDefinition.productionIdentifierInUDI has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.productionIdentifierInUDI has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version (new)) (Extension Type: code)
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-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())
                  36. DeviceDefinition.extension:guideline
                  Slice Nameguideline
                  Definition

                  R5: DeviceDefinition.guideline (new:BackboneElement)

                  ShortR5: Information aimed at providing directions for the usage of this model of device (new)
                  Comments

                  Element DeviceDefinition.guideline has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.guideline has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Information aimed at providing directions for the usage of this model of device (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  38. DeviceDefinition.extension:correctiveAction
                  Slice NamecorrectiveAction
                  Definition

                  R5: DeviceDefinition.correctiveAction (new:BackboneElement)

                  ShortR5: Tracking of latest field safety corrective action (new)
                  Comments

                  Element DeviceDefinition.correctiveAction has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.correctiveAction has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Tracking of latest field safety corrective action (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  40. DeviceDefinition.extension:chargeItem
                  Slice NamechargeItem
                  Definition

                  R5: DeviceDefinition.chargeItem (new:BackboneElement)

                  ShortR5: Billing code or reference associated with the device (new)
                  Comments

                  Element DeviceDefinition.chargeItem has a context of DeviceDefinition based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.chargeItem has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension(R5: Billing code or reference associated with the device (new)) (Complex Extension)
                  Is Modifierfalse
                  Invariantsele-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())
                  42. DeviceDefinition.modifierExtension
                  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 manageable, 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).

                  ShortExtensions that cannot be ignored
                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                  Summaryfalse
                  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.

                  Alternate Namesextensions, user content
                  Invariantsele-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())
                  44. DeviceDefinition.identifier
                  Definition

                  Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.

                  ShortInstance identifier
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..*
                  TypeIdentifier
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. DeviceDefinition.udiDeviceIdentifier
                  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.

                  ShortUnique Device Identifier (UDI) Barcode string
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. DeviceDefinition.udiDeviceIdentifier.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  50. DeviceDefinition.udiDeviceIdentifier.extension
                  Definition

                  An Extension

                  ShortExtension
                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-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())
                  SlicingThis element introduces a set of slices on DeviceDefinition.udiDeviceIdentifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 52. DeviceDefinition.udiDeviceIdentifier.extension:marketDistribution
                    Slice NamemarketDistribution
                    Definition

                    R5: DeviceDefinition.udiDeviceIdentifier.marketDistribution (new:BackboneElement)

                    ShortR5: Indicates whether and when the device is available on the market (new)
                    Comments

                    Element DeviceDefinition.udiDeviceIdentifier.marketDistribution has a context of DeviceDefinition.udiDeviceIdentifier based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.udiDeviceIdentifier.marketDistribution has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeExtension(R5: Indicates whether and when the device is available on the market (new)) (Complex Extension)
                    Is Modifierfalse
                    Invariantsele-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())
                    54. DeviceDefinition.udiDeviceIdentifier.modifierExtension
                    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 manageable, 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).

                    ShortExtensions that cannot be ignored even if unrecognized
                    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.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    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.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-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())
                    56. DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
                    Definition

                    The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.

                    ShortThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
                    Control1..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    58. DeviceDefinition.udiDeviceIdentifier.issuer
                    Definition

                    The organization that assigns the identifier algorithm.

                    ShortThe organization that assigns the identifier algorithm
                    Control1..1
                    Typeuri
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    60. DeviceDefinition.udiDeviceIdentifier.jurisdiction
                    Definition

                    The jurisdiction to which the deviceIdentifier applies.

                    ShortThe jurisdiction to which the deviceIdentifier applies
                    Control1..1
                    Typeuri
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    62. DeviceDefinition.manufacturer[x]
                    Definition

                    A name of the manufacturer.

                    ShortName of device manufacturer
                    Control0..1
                    TypeChoice of: string, Reference(Organization)
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. DeviceDefinition.deviceName
                    Definition

                    A name given to the device to identify it.

                    ShortA name given to the device to identify it
                    Control0..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. DeviceDefinition.deviceName.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    68. DeviceDefinition.deviceName.extension
                    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 manageable, 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.

                    ShortAdditional content defined by implementations
                    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.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-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())
                    70. DeviceDefinition.deviceName.modifierExtension
                    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 manageable, 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).

                    ShortExtensions that cannot be ignored even if unrecognized
                    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.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    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.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-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())
                    72. DeviceDefinition.deviceName.name
                    Definition

                    The name of the device.

                    ShortThe name of the device
                    Control1..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Alternate NamesΣ
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    74. DeviceDefinition.deviceName.type
                    Definition

                    The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

                    Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
                    Control1..1
                    BindingThe codes SHALL be taken from DeviceNameType
                    (required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

                    The type of name the device is referred by.

                    Typecode
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    76. DeviceDefinition.modelNumber
                    Definition

                    The model number for the device.

                    ShortThe model number for the device
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    78. DeviceDefinition.type
                    Definition

                    What kind of device or device system this is.

                    ShortWhat kind of device or device system this is
                    Control0..1
                    BindingFor example codes, see FHIRDeviceTypes
                    (example to http://hl7.org/fhir/ValueSet/device-kind|4.0.1)

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

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    80. DeviceDefinition.specialization
                    Definition

                    The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

                    ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
                    Control0..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    82. DeviceDefinition.specialization.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    84. DeviceDefinition.specialization.extension
                    Definition

                    An Extension

                    ShortExtension
                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-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())
                    SlicingThis element introduces a set of slices on DeviceDefinition.specialization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 86. DeviceDefinition.specialization.extension:conformsTo
                      Slice NameconformsTo
                      Definition

                      R5: DeviceDefinition.conformsTo

                      ShortR5: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
                      Comments

                      Element DeviceDefinition.conformsTo is mapped to FHIR R4 element DeviceDefinition.specialization as Equivalent. An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.conformsTo: http://hl7.org/fhir/StructureDefinition/device-conformsTo.

                      Control0..*
                      TypeExtension(http://hl7.org/fhir/StructureDefinition/device-conformsTo)
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-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())
                      88. DeviceDefinition.specialization.modifierExtension
                      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 manageable, 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).

                      ShortExtensions that cannot be ignored even if unrecognized
                      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.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      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.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-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())
                      90. DeviceDefinition.specialization.systemType
                      Definition

                      The standard that is used to operate and communicate.

                      ShortThe standard that is used to operate and communicate
                      Control1..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summaryfalse
                      Alternate NamesΣ
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      92. DeviceDefinition.specialization.version
                      Definition

                      The version of the standard that is used to operate and communicate.

                      ShortThe version of the standard that is used to operate and communicate
                      NoteThis is a business version Id, not a resource version Id (see discussion)
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      94. DeviceDefinition.version
                      Definition

                      The available versions of the device, e.g., software versions.

                      ShortAvailable versions
                      NoteThis is a business version Id, not a resource version Id (see discussion)
                      Control0..*
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      96. DeviceDefinition.version.id
                      Definition

                      unique id for the element within a resource (for internal references)

                      Shortxml:id (or equivalent in JSON)
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      98. DeviceDefinition.version.extension
                      Definition

                      An Extension

                      ShortExtension
                      Control1..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-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())
                      SlicingThis element introduces a set of slices on DeviceDefinition.version.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 100. DeviceDefinition.version.extension:type
                        Slice Nametype
                        Definition

                        R5: DeviceDefinition.version.type (new:CodeableConcept)

                        ShortR5: The type of the device version, e.g. manufacturer, approved, internal (new)
                        Comments

                        Element DeviceDefinition.version.type has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(R5: The type of the device version, e.g. manufacturer, approved, internal (new)) (Extension Type: CodeableConcept)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-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())
                        102. DeviceDefinition.version.extension:component
                        Slice Namecomponent
                        Definition

                        R5: DeviceDefinition.version.component (new:Identifier)

                        ShortR5: The hardware or software module of the device to which the version applies (new)
                        Comments

                        Element DeviceDefinition.version.component has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.component has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). 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.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(R5: The hardware or software module of the device to which the version applies (new)) (Extension Type: Identifier)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-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())
                        104. DeviceDefinition.version.extension:value
                        Slice Namevalue
                        Definition

                        R5: DeviceDefinition.version.value (new:string)

                        ShortR5: The version text (new)
                        Comments

                        Element DeviceDefinition.version.value has a context of DeviceDefinition.version based on following the parent source element upwards and mapping to DeviceDefinition. Element DeviceDefinition.version.value has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

                        Control1..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(R5: The version text (new)) (Extension Type: string)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-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())
                        106. DeviceDefinition.version.value
                        Definition

                        The actual value

                        ShortPrimitive value for string
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        Max Length:1048576
                        108. DeviceDefinition.safety
                        Definition

                        Safety characteristics of the device.

                        ShortSafety characteristics of the device
                        Control0..*
                        BindingFor example codes, see DeviceSafety
                        (example to http://hl7.org/fhir/ValueSet/device-safety|4.0.1)
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        110. DeviceDefinition.shelfLifeStorage
                        Definition

                        Shelf Life and storage information.

                        ShortShelf Life and storage information
                        Control0..*
                        TypeProductShelfLife
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        112. DeviceDefinition.physicalCharacteristics
                        Definition

                        Dimensions, color etc.

                        ShortDimensions, color etc.
                        Control0..1
                        TypeProdCharacteristic
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        114. DeviceDefinition.languageCode
                        Definition

                        Language code for the human-readable text strings produced by the device (all supported).

                        ShortLanguage code for the human-readable text strings produced by the device (all supported)
                        Control0..*
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        116. DeviceDefinition.capability
                        Definition

                        Device capabilities.

                        ShortDevice capabilities
                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        118. DeviceDefinition.capability.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        120. DeviceDefinition.capability.extension
                        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 manageable, 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.

                        ShortAdditional content defined by implementations
                        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.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-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())
                        122. DeviceDefinition.capability.modifierExtension
                        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 manageable, 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).

                        ShortExtensions that cannot be ignored even if unrecognized
                        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.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        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.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-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())
                        124. DeviceDefinition.capability.type
                        Definition

                        Type of capability.

                        ShortType of capability
                        Control1..1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        126. DeviceDefinition.capability.description
                        Definition

                        Description of capability.

                        ShortDescription of capability
                        Control0..*
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        128. DeviceDefinition.property
                        Definition

                        The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

                        ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        130. DeviceDefinition.property.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        132. DeviceDefinition.property.extension
                        Definition

                        An Extension

                        ShortExtension
                        Control1..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-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())
                        SlicingThis element introduces a set of slices on DeviceDefinition.property.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 134. DeviceDefinition.property.extension:value
                          Slice Namevalue
                          Definition

                          R5: DeviceDefinition.property.value[x] additional types (string, boolean, integer, Range, Attachment)

                          ShortR5: Value of the property additional types
                          Comments

                          Element DeviceDefinition.property.value[x] is mapped to FHIR R4 element DeviceDefinition.property.valueQuantity as RelatedTo. Element DeviceDefinition.property.value[x] is mapped to FHIR R4 element DeviceDefinition.property.valueCode as RelatedTo. The mappings for DeviceDefinition.property.value[x] do not cover the following types: Attachment, boolean, integer, Range, string. 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.

                          Control1..1
                          This element is affected by the following invariants: ele-1
                          TypeExtension(R5: Value of the property additional types) (Extension Type: Choice of: string, boolean, integer, Range, Attachment)
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-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())
                          136. DeviceDefinition.property.modifierExtension
                          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 manageable, 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).

                          ShortExtensions that cannot be ignored even if unrecognized
                          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.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          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.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-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())
                          138. DeviceDefinition.property.type
                          Definition

                          Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

                          ShortCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
                          Control1..1
                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          140. DeviceDefinition.property.valueQuantity
                          Definition

                          Property value as a quantity.

                          ShortProperty value as a quantity
                          Control0..*
                          TypeQuantity
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          142. DeviceDefinition.property.valueCode
                          Definition

                          Property value as a code, e.g., NTP4 (synced to NTP).

                          ShortProperty value as a code, e.g., NTP4 (synced to NTP)
                          Control0..*
                          TypeCodeableConcept
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          144. DeviceDefinition.owner
                          Definition

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

                          ShortOrganization responsible for device
                          Control0..1
                          TypeReference(Organization)
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          146. DeviceDefinition.contact
                          Definition

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

                          ShortDetails for human/organization for support
                          Comments

                          used for troubleshooting etc.

                          Control0..*
                          TypeContactPoint
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          148. DeviceDefinition.contact.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          150. DeviceDefinition.contact.extension
                          Definition

                          An Extension

                          ShortExtension
                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-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())
                          SlicingThis element introduces a set of slices on DeviceDefinition.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 152. DeviceDefinition.contact.extension:contact
                            Slice Namecontact
                            Definition

                            R5: DeviceDefinition.contact

                            ShortR5: contact
                            Comments

                            Element DeviceDefinition.contact is mapped to FHIR R4 element DeviceDefinition.contact as Equivalent. An externally-defined extension that has been mapped as the representation of FHIR R5 element DeviceDefinition.contact: http://hl7.org/fhir/StructureDefinition/artifact-contact. used for troubleshooting etc.

                            Control0..*
                            TypeExtension(Artifact Contact) (Extension Type: ContactDetail)
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-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())
                            154. DeviceDefinition.contact.system
                            Definition

                            Telecommunications form for contact point - what communications system is required to make use of the contact.

                            Shortphone | fax | email | pager | url | sms | other
                            Control0..1
                            This element is affected by the following invariants: cpt-2
                            BindingThe codes SHALL be taken from ContactPointSystem
                            (required to http://hl7.org/fhir/ValueSet/contact-point-system|4.0.1)

                            Telecommunications form for contact point.

                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            156. DeviceDefinition.contact.value
                            Definition

                            The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

                            ShortThe actual contact point details
                            Comments

                            Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to support legacy numbers that are not in a tightly controlled format.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            158. DeviceDefinition.contact.use
                            Definition

                            Identifies the purpose for the contact point.

                            Shorthome | work | temp | old | mobile - purpose of this contact point
                            Comments

                            Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

                            Control0..1
                            BindingThe codes SHALL be taken from ContactPointUse
                            (required to http://hl7.org/fhir/ValueSet/contact-point-use|4.0.1)

                            Use of contact point.

                            Typecode
                            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            160. DeviceDefinition.contact.rank
                            Definition

                            Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.

                            ShortSpecify preferred order of use (1 = highest)
                            Comments

                            Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

                            Control0..1
                            TypepositiveInt
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            162. DeviceDefinition.contact.period
                            Definition

                            Time period when the contact point was/is in use.

                            ShortTime period when the contact point was/is in use
                            Control0..1
                            TypePeriod
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            164. DeviceDefinition.url
                            Definition

                            A network address on which the device may be contacted directly.

                            ShortNetwork address to contact device
                            Comments

                            If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

                            Control0..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            166. DeviceDefinition.onlineInformation
                            Definition

                            Access to on-line information about the device.

                            ShortAccess to on-line information
                            Control0..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            168. DeviceDefinition.note
                            Definition

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

                            ShortDevice notes and comments
                            Control0..*
                            TypeAnnotation
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            170. DeviceDefinition.quantity
                            Definition

                            The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).

                            ShortThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
                            Control0..1
                            TypeQuantity
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            172. DeviceDefinition.parentDevice
                            Definition

                            The parent device it can be part of.

                            ShortThe parent device it can be part of
                            Control0..1
                            TypeReference(DeviceDefinition)
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            174. DeviceDefinition.material
                            Definition

                            A substance used to create the material(s) of which the device is made.

                            ShortA substance used to create the material(s) of which the device is made
                            Control0..*
                            TypeBackboneElement
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            176. DeviceDefinition.material.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            178. DeviceDefinition.material.extension
                            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 manageable, 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.

                            ShortAdditional content defined by implementations
                            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.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-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())
                            180. DeviceDefinition.material.modifierExtension
                            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 manageable, 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).

                            ShortExtensions that cannot be ignored even if unrecognized
                            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.

                            Control0..*
                            TypeExtension
                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                            Summarytrue
                            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.

                            Alternate Namesextensions, user content, modifiers
                            Invariantsele-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())
                            182. DeviceDefinition.material.substance
                            Definition

                            The substance.

                            ShortThe substance
                            Control1..1
                            TypeCodeableConcept
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            184. DeviceDefinition.material.alternate
                            Definition

                            Indicates an alternative material of the device.

                            ShortIndicates an alternative material of the device
                            Control0..1
                            Typeboolean
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            186. DeviceDefinition.material.allergenicIndicator
                            Definition

                            Whether the substance is a known or suspected allergen.

                            ShortWhether the substance is a known or suspected allergen
                            Control0..1
                            Typeboolean
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))