DeviceModel
type: StructureDefinition
node role: treeRoot
id:
  v: DeviceModel
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition DeviceModel Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:CatalogReference 0..* Reference(Catalog Header) Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference #xD; description S 0..1 markdown Additional information to describe the device #xD; identifier S 0..* Identifier Instance identifier #xD; udiDeviceIdentifier S 0..* BackboneElement Unique Device Identifier (UDI) Barcode string #xD; deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier #xD; <a href="StructureDefinition-DeviceModel-definitions.html#DeviceDefinition.udiDeviceIdentifier.issuer" title="Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:#xA;1. GS1 GTIN: urn:oid:1.3.160,#xA;2. HIBCC: urn:oid:2.16.840.1.113883.6.40,#xA;3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,#xA;4. ICCBBA for other devices: to be found,#xA;5. IFA (Europe Union only): to be found">issuer 1..1 uri The organization that assigns the identifier algorithm #xD; jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies #xD; marketDistribution S 0..* BackboneElement Indicates whether and when the device is available on the market #xD; marketPeriod #xD; start 0..1 dateTime Starting time with inclusive boundary #xD; end 0..1 dateTime End time with inclusive boundary, if not ongoing #xD; subJurisdiction 1..1 uri National state or territory where the device i…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: oo
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 2
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog
        l: ig-uv-order-catalog
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog
        l: ig-uv-order-catalog
url:
  v: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel
  l: DeviceModel
identifier:
  system:
    v: urn:ietf:rfc:3986
    l: 3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.55.42.2
version:
  v: 1.0.0
name:
  v: DeviceModel
title:
  v: Device Model
status:
  v: active
date:
  v: 2022-02-20T18:06:45+01:00
publisher:
  v: HL7 International / Orders and Observations
contact:
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/orders
description:
  v: This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: devicedefinition-to-eudamed
  uri:
    v: https://ec.europa.eu/tools/eudamed
    l: eudamed
  name:
    v: Europe Union EUDAMED
  comment:
    v: maps DeviceDefinition elements to EUDAMED UDI data dictionary field IDs|labels
mapping:
  identity:
    v: devicedefinition-to-gudid
  uri:
    v: https://accessgudid.nlm.nih.gov/
    l: accessgudid.nlm.nih.gov
  name:
    v: US GUDID
  comment:
    v: maps DeviceDefinition elements to AccessGUDID section titles and field labels
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
    l: fivews
  name:
    v: FiveWs Pattern Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: DeviceDefinition
  l: DeviceDefinition
base definition:
  v: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
  l: DeviceDefinition
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 5.0.0
  element:
    id:
      v: DeviceDefinition
    path:
      v: DeviceDefinition
    short:
      v: An instance of a medical-related component of a medical device
    definition:
      v: The characteristics, operational status and capabilities of a medical-related component of a medical device.
    comment:
      v: For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: DeviceDefinition
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
      expression:
        v: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice
    l: elementdefinition-bestpractice
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation
    l: elementdefinition-bestpractice-explanation
  value: Markdown
    v: When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
key:
  v: dom-6
severity:
  v: warning
human:
  v: A resource should have narrative for robust management
expression:
  v: text.`div`.exists()
source:
  v: http://hl7.org/fhir/StructureDefinition/DomainResource
  l: DomainResource

v: false

v: false

v: false

identity:
  v: devicedefinition-to-eudamed
map:
  v: EUDAMED data dictionary field IDs/labels

identity:
  v: devicedefinition-to-gudid
map:
  v: AccessGUDID section titles and field labels

identity:
  v: rim
map:
  v: Entity, Role, or Act

identity:
  v: w5
map:
  v: administrative.device

id:
  v: DeviceDefinition.id
path:
  v: DeviceDefinition.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.meta
path:
  v: DeviceDefinition.meta
short:
  v: Metadata about the resource
definition:
  v: The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
    l: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.implicitRules
path:
  v: DeviceDefinition.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
comment:
  v: Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
is summary:
  v: true

id:
  v: DeviceDefinition.language
path:
  v: DeviceDefinition.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|5.0.0
    l: http://hl7.org/fhir/ValueSet/all-languages
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages|5.0.0
      l: http://hl7.org/fhir/ValueSet/languages

id:
  v: DeviceDefinition.text
path:
  v: DeviceDefinition.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
comment:
  v: Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
    l: Narrative
condition:
  v: dom-6
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: DeviceDefinition.contained
path:
  v: DeviceDefinition.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
    l: Resource
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.extension
path:
  v: DeviceDefinition.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.extension:CatalogReference
path:
  v: DeviceDefinition.extension
slice name:
  v: CatalogReference
short:
  v: Reference to a catalog
definition:
  v: This extension to PlanDefinition, MedicationKnowledge and DeviceDefinition conveys the reference to a catalog containing the extended resource
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference
    l: CatalogReference
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.modifierExtension
path:
  v: DeviceDefinition.modifierExtension
short:
  v: Extensions that cannot be ignored
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.description
path:
  v: DeviceDefinition.description
short:
  v: Additional information to describe the device
definition:
  v: Additional information to describe the device.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-175|Additional product description
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Device Description

id:
  v: DeviceDefinition.identifier
path:
  v: DeviceDefinition.identifier
short:
  v: Instance identifier
definition:
  v: This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI. identifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier

id:
  v: DeviceDefinition.udiDeviceIdentifier
path:
  v: DeviceDefinition.udiDeviceIdentifier
short:
  v: Unique Device Identifier (UDI) Barcode string
definition:
  v: Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.udiDeviceIdentifier.id
path:
  v: DeviceDefinition.udiDeviceIdentifier.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.extension
path:
  v: DeviceDefinition.udiDeviceIdentifier.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.modifierExtension
path:
  v: DeviceDefinition.udiDeviceIdentifier.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
path:
  v: DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
short:
  v: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
definition:
  v: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-178|UDI-DI code
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Primary DI Number

id:
  v: DeviceDefinition.udiDeviceIdentifier.issuer
path:
  v: DeviceDefinition.udiDeviceIdentifier.issuer
short:
  v: The organization that assigns the identifier algorithm
definition:
  v: Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include: 1. GS1 GTIN: urn:oid:1.3.160, 2. HIBCC: urn:oid:2.16.840.1.113883.6.40, 3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18, 4. ICCBBA for other devices: to be found, 5. IFA (Europe Union only): to be found
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.issuer
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-291|Issuing Entity UDI-DI
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Primary DI Number - Issuing Agency

id:
  v: DeviceDefinition.udiDeviceIdentifier.jurisdiction
path:
  v: DeviceDefinition.udiDeviceIdentifier.jurisdiction
short:
  v: The jurisdiction to which the deviceIdentifier applies
definition:
  v: The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are: 1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150, 2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.jurisdiction
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: https://ec.europa.eu/health/medical-devices-sector_en
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: urn:oid:2.16.840.1.113883.3.150

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution
short:
  v: Indicates whether and when the device is available on the market
definition:
  v: Indicates where and when the device is available on the market.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.id
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
short:
  v: Begin and end dates for the commercial distribution of the device
definition:
  v: Begin and end dates for the commercial distribution of the device.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Period
    l: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start
short:
  v: Starting time with inclusive boundary
definition:
  v: The start of the period. The boundary is inclusive.
comment:
  v: If the low element is missing, the meaning is that the low boundary is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Period.start
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
condition:
  v: per-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-250|Start date
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: DEVICE RECORD STATUS - DI Record Publish Date
mapping:
  identity:
    v: v2
  map:
    v: DR.1
mapping:
  identity:
    v: rim
  map:
    v: ./low

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end
short:
  v: End time with inclusive boundary, if not ongoing
definition:
  v: The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
comment:
  v: The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Period.end
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
meaning when missing:
  v: If the end of the period is missing, it means that the period is ongoing
condition:
  v: per-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-251|End date
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Commercial Distribution End Date
mapping:
  identity:
    v: v2
  map:
    v: DR.2
mapping:
  identity:
    v: rim
  map:
    v: ./high

id:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
path:
  v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
short:
  v: National state or territory where the device is commercialized
definition:
  v: National state or territory to which the marketDistribution recers, typically where the device is commercialized.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-141|Countries were the devices is made available
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: urn:oid:2.16.840.1.113883.3.150

id:
  v: DeviceDefinition.regulatoryIdentifier
path:
  v: DeviceDefinition.regulatoryIdentifier
short:
  v: Regulatory identifier(s) associated with this device
definition:
  v: Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.
comment:
  v: This should not be used for regulatory authorization numbers which are to be captured elsewhere.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.regulatoryIdentifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.regulatoryIdentifier.id
path:
  v: DeviceDefinition.regulatoryIdentifier.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.regulatoryIdentifier.extension
path:
  v: DeviceDefinition.regulatoryIdentifier.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.regulatoryIdentifier.modifierExtension
path:
  v: DeviceDefinition.regulatoryIdentifier.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.regulatoryIdentifier.type
path:
  v: DeviceDefinition.regulatoryIdentifier.type
short:
  v: basic | master | license
definition:
  v: The type of identifier itself.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.regulatoryIdentifier.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceRegulatoryIdentifierType
  strength:
    v: required
  description:
    v: Device regulatory identifier type.
  value set:
    v: http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type

id:
  v: DeviceDefinition.regulatoryIdentifier.deviceIdentifier
path:
  v: DeviceDefinition.regulatoryIdentifier.deviceIdentifier
short:
  v: The identifier itself
definition:
  v: The identifier itself.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.regulatoryIdentifier.deviceIdentifier
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.regulatoryIdentifier.issuer
path:
  v: DeviceDefinition.regulatoryIdentifier.issuer
short:
  v: The organization that issued this identifier
definition:
  v: The organization that issued this identifier.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.regulatoryIdentifier.issuer
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.regulatoryIdentifier.jurisdiction
path:
  v: DeviceDefinition.regulatoryIdentifier.jurisdiction
short:
  v: The jurisdiction to which the deviceIdentifier applies
definition:
  v: The jurisdiction to which the deviceIdentifier applies.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.regulatoryIdentifier.jurisdiction
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.partNumber
path:
  v: DeviceDefinition.partNumber
short:
  v: The part number or catalog number of the device
definition:
  v: The part number or catalog number of the device.
comment:
  v: Alphanumeric Maximum 20.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.partNumber
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-163|Reference / Catalogue Number
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Catalog Number
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: rim
  map:
    v: .playedRole[typeCode=MANU].id

id:
  v: DeviceDefinition.manufacturer
path:
  v: DeviceDefinition.manufacturer
short:
  v: Name of device manufacturer
definition:
  v: A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.manufacturer
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization|5.0.0
    l: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-10|Legal Manufacturer SRN
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Company Name
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: rim
  map:
    v: .playedRole[typeCode=MANU].scoper.name

id:
  v: DeviceDefinition.deviceName
path:
  v: DeviceDefinition.deviceName
short:
  v: The name or names of the device as given by the manufacturer
definition:
  v: The name or names of the device as given by the manufacturer.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.deviceName
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.deviceName.id
path:
  v: DeviceDefinition.deviceName.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.deviceName.extension
path:
  v: DeviceDefinition.deviceName.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.deviceName.modifierExtension
path:
  v: DeviceDefinition.deviceName.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.deviceName.name
path:
  v: DeviceDefinition.deviceName.name
short:
  v: A name that is used to refer to the device
definition:
  v: A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.
alias:
  v: Σ
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.deviceName.name
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-22|Device Name
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Brand Name

id:
  v: DeviceDefinition.deviceName.type
path:
  v: DeviceDefinition.deviceName.type
short:
  v: registered-name | user-friendly-name | patient-reported-name
definition:
  v: The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.deviceName.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceNameType
  strength:
    v: required
  description:
    v: The type of name the device is referred by.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-nametype|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-nametype
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: [registered-name]
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: [registered-name]
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: rim
  map:
    v: .playedRole[typeCode=MANU].code

id:
  v: DeviceDefinition.modelNumber
path:
  v: DeviceDefinition.modelNumber
short:
  v: The catalog or model number for the device for example as defined by the manufacturer
definition:
  v: The model number for the device for example as defined by the manufacturer or labeler, or other agency.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.modelNumber
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-20|Device Model
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Version or Model
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: rim
  map:
    v: .softwareName (included as part)

id:
  v: DeviceDefinition.classification
path:
  v: DeviceDefinition.classification
slicing:
  discriminator:
    type:
      v: value
    path:
      v: type.coding.system
  description:
    v: Slice based on classification coding system
  rules:
    v: open
short:
  v: What kind of device or device system this is
definition:
  v: What kind of device or device system this is.
comment:
  v: In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.classification.id
path:
  v: DeviceDefinition.classification.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification.extension
path:
  v: DeviceDefinition.classification.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification.modifierExtension
path:
  v: DeviceDefinition.classification.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.classification.type
path:
  v: DeviceDefinition.classification.type
short:
  v: A classification or risk class of the device model
definition:
  v: A classification or risk class of the device model.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceKind
  strength:
    v: example
  description:
    v: Type of device e.g. according to official classification.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-type

id:
  v: DeviceDefinition.classification.justification
path:
  v: DeviceDefinition.classification.justification
short:
  v: Further information qualifying this classification of the device model
definition:
  v: Further information qualifying this classification of the device model.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification.justification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.classification:gmdn
path:
  v: DeviceDefinition.classification
slice name:
  v: gmdn
short:
  v: GMDN classification
definition:
  v: Global Medical Device Nomenclature classification
comment:
  v: In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.classification:gmdn.id
path:
  v: DeviceDefinition.classification.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.extension
path:
  v: DeviceDefinition.classification.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.modifierExtension
path:
  v: DeviceDefinition.classification.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.classification:gmdn.type
path:
  v: DeviceDefinition.classification.type
short:
  v: A classification or risk class of the device model
definition:
  v: A classification or risk class of the device model.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceKind
  strength:
    v: example
  description:
    v: Type of device e.g. according to official classification.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-type

id:
  v: DeviceDefinition.classification:gmdn.type.id
path:
  v: DeviceDefinition.classification.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.type.extension
path:
  v: DeviceDefinition.classification.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.type.coding
path:
  v: DeviceDefinition.classification.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: DeviceDefinition.classification:gmdn.type.coding.id
path:
  v: DeviceDefinition.classification.type.coding.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.type.coding.extension
path:
  v: DeviceDefinition.classification.type.coding.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:gmdn.type.coding.system
path:
  v: DeviceDefinition.classification.type.coding.system
short:
  v: Identity of the terminology system
definition:
  v: The identification of the code system that defines the meaning of the symbol in the code.
comment:
  v: The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
requirements:
  v: Need to be unambiguous about the source of the definition of the symbol.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Coding.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: http://terminology.hl7.org/CodeSystem/GMDN
  l: GMDN
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: http://terminology.hl7.org/CodeSystem/GMDN
mapping:
  identity:
    v: v2
  map:
    v: C*E.3
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystem
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem

id:
  v: DeviceDefinition.classification:gmdn.type.coding.version
path:
  v: DeviceDefinition.classification.type.coding.version
short:
  v: Version of the system - if relevant
definition:
  v: The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
comment:
  v: Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.version
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.7
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystemVersion
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion

id:
  v: DeviceDefinition.classification:gmdn.type.coding.code
path:
  v: DeviceDefinition.classification.type.coding.code
short:
  v: Symbol in syntax defined by the system
definition:
  v: A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
requirements:
  v: Need to refer to a particular code in the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: [GMDN code]
mapping:
  identity:
    v: v2
  map:
    v: C*E.1
mapping:
  identity:
    v: rim
  map:
    v: ./code
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code

id:
  v: DeviceDefinition.classification:gmdn.type.coding.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.coding.display
short:
  v: Representation defined by the system
definition:
  v: A representation of the meaning of the code in the system, following the rules of the system.
requirements:
  v: Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: GMDN Preferred Term Name
mapping:
  identity:
    v: v2
  map:
    v: C*E.2 - but note this is not well followed
mapping:
  identity:
    v: rim
  map:
    v: CV.displayName
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName

id:
  v: DeviceDefinition.classification:gmdn.type.coding.userSelected
path:
  v: DeviceDefinition.classification.type.coding.userSelected
short:
  v: If this coding was chosen directly by the user
definition:
  v: Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
comment:
  v: Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
requirements:
  v: This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.userSelected
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
    l: boolean
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: Sometimes implied by being first
mapping:
  identity:
    v: rim
  map:
    v: CD.codingRationale
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]

id:
  v: DeviceDefinition.classification:gmdn.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: DeviceDefinition.classification:gmdn.justification
path:
  v: DeviceDefinition.classification.justification
short:
  v: Further information qualifying this classification of the device model
definition:
  v: Further information qualifying this classification of the device model.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification.justification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.classification:snomed
path:
  v: DeviceDefinition.classification
slice name:
  v: snomed
short:
  v: SNOMED CT
definition:
  v: Systematized nomenclature of medicine - clinical terms
comment:
  v: In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.classification:snomed.id
path:
  v: DeviceDefinition.classification.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.extension
path:
  v: DeviceDefinition.classification.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.modifierExtension
path:
  v: DeviceDefinition.classification.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.classification:snomed.type
path:
  v: DeviceDefinition.classification.type
short:
  v: A classification or risk class of the device model
definition:
  v: A classification or risk class of the device model.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceKind
  strength:
    v: example
  description:
    v: Type of device e.g. according to official classification.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-type

id:
  v: DeviceDefinition.classification:snomed.type.id
path:
  v: DeviceDefinition.classification.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.type.extension
path:
  v: DeviceDefinition.classification.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.type.coding
path:
  v: DeviceDefinition.classification.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: DeviceDefinition.classification:snomed.type.coding.id
path:
  v: DeviceDefinition.classification.type.coding.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.type.coding.extension
path:
  v: DeviceDefinition.classification.type.coding.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:snomed.type.coding.system
path:
  v: DeviceDefinition.classification.type.coding.system
short:
  v: Identity of the terminology system
definition:
  v: The identification of the code system that defines the meaning of the symbol in the code.
comment:
  v: The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
requirements:
  v: Need to be unambiguous about the source of the definition of the symbol.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Coding.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: http://snomed.info/sct
  l: sct
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.3
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystem
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem

id:
  v: DeviceDefinition.classification:snomed.type.coding.version
path:
  v: DeviceDefinition.classification.type.coding.version
short:
  v: Version of the system - if relevant
definition:
  v: The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
comment:
  v: Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.version
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.7
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystemVersion
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion

id:
  v: DeviceDefinition.classification:snomed.type.coding.code
path:
  v: DeviceDefinition.classification.type.coding.code
short:
  v: Symbol in syntax defined by the system
definition:
  v: A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
requirements:
  v: Need to refer to a particular code in the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1
mapping:
  identity:
    v: rim
  map:
    v: ./code
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code

id:
  v: DeviceDefinition.classification:snomed.type.coding.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.coding.display
short:
  v: Representation defined by the system
definition:
  v: A representation of the meaning of the code in the system, following the rules of the system.
requirements:
  v: Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.2 - but note this is not well followed
mapping:
  identity:
    v: rim
  map:
    v: CV.displayName
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName

id:
  v: DeviceDefinition.classification:snomed.type.coding.userSelected
path:
  v: DeviceDefinition.classification.type.coding.userSelected
short:
  v: If this coding was chosen directly by the user
definition:
  v: Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
comment:
  v: Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
requirements:
  v: This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.userSelected
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
    l: boolean
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: Sometimes implied by being first
mapping:
  identity:
    v: rim
  map:
    v: CD.codingRationale
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]

id:
  v: DeviceDefinition.classification:snomed.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: DeviceDefinition.classification:snomed.justification
path:
  v: DeviceDefinition.classification.justification
short:
  v: Further information qualifying this classification of the device model
definition:
  v: Further information qualifying this classification of the device model.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification.justification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.classification:emdn
path:
  v: DeviceDefinition.classification
slice name:
  v: emdn
short:
  v: EMDN
definition:
  v: European Medical Device Nomenclature
comment:
  v: In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.classification:emdn.id
path:
  v: DeviceDefinition.classification.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.extension
path:
  v: DeviceDefinition.classification.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.modifierExtension
path:
  v: DeviceDefinition.classification.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.classification:emdn.type
path:
  v: DeviceDefinition.classification.type
short:
  v: A classification or risk class of the device model
definition:
  v: A classification or risk class of the device model.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.classification.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceKind
  strength:
    v: example
  description:
    v: Type of device e.g. according to official classification.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-type

id:
  v: DeviceDefinition.classification:emdn.type.id
path:
  v: DeviceDefinition.classification.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.type.extension
path:
  v: DeviceDefinition.classification.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.type.coding
path:
  v: DeviceDefinition.classification.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: DeviceDefinition.classification:emdn.type.coding.id
path:
  v: DeviceDefinition.classification.type.coding.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.type.coding.extension
path:
  v: DeviceDefinition.classification.type.coding.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.classification:emdn.type.coding.system
path:
  v: DeviceDefinition.classification.type.coding.system
short:
  v: Identity of the terminology system
definition:
  v: The identification of the code system that defines the meaning of the symbol in the code.
comment:
  v: The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
requirements:
  v: Need to be unambiguous about the source of the definition of the symbol.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Coding.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: urn:oid:1.2.250.1.213.2.68
  l: 1.2.250.1.213.2.68
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: urn:oid:1.2.250.1.213.2.68
mapping:
  identity:
    v: v2
  map:
    v: C*E.3
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystem
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem

id:
  v: DeviceDefinition.classification:emdn.type.coding.version
path:
  v: DeviceDefinition.classification.type.coding.version
short:
  v: Version of the system - if relevant
definition:
  v: The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
comment:
  v: Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.version
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.7
mapping:
  identity:
    v: rim
  map:
    v: ./codeSystemVersion
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion

id:
  v: DeviceDefinition.classification:emdn.type.coding.code
path:
  v: DeviceDefinition.classification.type.coding.code
short:
  v: Symbol in syntax defined by the system
definition:
  v: A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
requirements:
  v: Need to refer to a particular code in the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: [EMDN code]
mapping:
  identity:
    v: v2
  map:
    v: C*E.1
mapping:
  identity:
    v: rim
  map:
    v: ./code
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code

id:
  v: DeviceDefinition.classification:emdn.type.coding.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.coding.display
short:
  v: Representation defined by the system
definition:
  v: A representation of the meaning of the code in the system, following the rules of the system.
requirements:
  v: Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: cod-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: EMDN name
mapping:
  identity:
    v: v2
  map:
    v: C*E.2 - but note this is not well followed
mapping:
  identity:
    v: rim
  map:
    v: CV.displayName
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName

id:
  v: DeviceDefinition.classification:emdn.type.coding.userSelected
path:
  v: DeviceDefinition.classification.type.coding.userSelected
short:
  v: If this coding was chosen directly by the user
definition:
  v: Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
comment:
  v: Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
requirements:
  v: This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Coding.userSelected
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
    l: boolean
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: Sometimes implied by being first
mapping:
  identity:
    v: rim
  map:
    v: CD.codingRationale
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]

id:
  v: DeviceDefinition.classification:emdn.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: DeviceDefinition.classification.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: DeviceDefinition.classification:emdn.justification
path:
  v: DeviceDefinition.classification.justification
short:
  v: Further information qualifying this classification of the device model
definition:
  v: Further information qualifying this classification of the device model.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.classification.justification
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.conformsTo
path:
  v: DeviceDefinition.conformsTo
short:
  v: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
definition:
  v: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.conformsTo
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.conformsTo.id
path:
  v: DeviceDefinition.conformsTo.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.conformsTo.extension
path:
  v: DeviceDefinition.conformsTo.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.conformsTo.modifierExtension
path:
  v: DeviceDefinition.conformsTo.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.conformsTo.category
path:
  v: DeviceDefinition.conformsTo.category
short:
  v: Describes the common type of the standard, specification, or formal guidance
definition:
  v: Describes the type of the standard, specification, or formal guidance.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.conformsTo.category
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceSpecificationCategory
  strength:
    v: example
  value set:
    v: http://hl7.org/fhir/ValueSet/device-specification-category|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-specification-category

id:
  v: DeviceDefinition.conformsTo.specification
path:
  v: DeviceDefinition.conformsTo.specification
short:
  v: Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
definition:
  v: Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.conformsTo.specification
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DeviceSpecificationType
  strength:
    v: example
  value set:
    v: http://hl7.org/fhir/ValueSet/device-specification-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-specification-type

id:
  v: DeviceDefinition.conformsTo.version
path:
  v: DeviceDefinition.conformsTo.version
short:
  v: The specific form or variant of the standard, specification or formal guidance
definition:
  v: Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.conformsTo.version
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.conformsTo.source
path:
  v: DeviceDefinition.conformsTo.source
short:
  v: Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
definition:
  v: Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.conformsTo.source
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.hasPart
path:
  v: DeviceDefinition.hasPart
short:
  v: A device, part of the current one
definition:
  v: A device that is part (for example a component) of the present device.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.hasPart
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.hasPart.id
path:
  v: DeviceDefinition.hasPart.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.hasPart.extension
path:
  v: DeviceDefinition.hasPart.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.hasPart.modifierExtension
path:
  v: DeviceDefinition.hasPart.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.hasPart.reference
path:
  v: DeviceDefinition.hasPart.reference
short:
  v: Reference to the part
definition:
  v: Reference to the device that is part of the current device.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.hasPart.reference
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DeviceDefinition|5.0.0
    l: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: DeviceDefinition.hasPart.count
path:
  v: DeviceDefinition.hasPart.count
short:
  v: Number of occurrences of the part
definition:
  v: Number of instances of the component device in the current device.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.hasPart.count
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    v: 0
  max:
    v: 1
type:
  code:
    v: integer
    l: integer
constraint:
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    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging
path:
  v: DeviceDefinition.packaging
short:
  v: Information about the packaging of the device, i.e. how the device is packaged
definition:
  v: Information about the packaging of the device, i.e. how the device is packaged.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.packaging
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    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
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constraint:
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    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
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must support:
  v: false
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  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.id
path:
  v: DeviceDefinition.packaging.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
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    v: 0
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    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.extension
path:
  v: DeviceDefinition.packaging.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
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  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
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    v: 0
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type:
  code:
    v: Extension
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  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.modifierExtension
path:
  v: DeviceDefinition.packaging.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
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  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.packaging.identifier
path:
  v: DeviceDefinition.packaging.identifier
short:
  v: Business identifier of the packaged medication
definition:
  v: The business identifier of the packaged medication.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.packaging.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
    l: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.type
path:
  v: DeviceDefinition.packaging.type
short:
  v: A code that defines the specific type of packaging
definition:
  v: A code that defines the specific type of packaging.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.packaging.type
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    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Package Type

id:
  v: DeviceDefinition.packaging.count
path:
  v: DeviceDefinition.packaging.count
short:
  v: The number of items contained in the package (devices or sub-packages)
definition:
  v: The number of items contained in the package (devices or sub-packages).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.packaging.count
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: integer
    l: integer
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-121|Quantity of item(s)
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Quantity per Package

id:
  v: DeviceDefinition.packaging.distributor
path:
  v: DeviceDefinition.packaging.distributor
short:
  v: An organization that distributes the packaged device
definition:
  v: An organization that distributes the packaged device.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.packaging.distributor
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.distributor.id
path:
  v: DeviceDefinition.packaging.distributor.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
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    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
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    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
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short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
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alias:
  v: user content
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max:
  v: *
base:
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    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
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    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    l: Element
constraint:
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    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.distributor.modifierExtension
path:
  v: DeviceDefinition.packaging.distributor.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
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max:
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base:
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    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
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    v: ext-1
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    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
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  v: true
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.packaging.distributor.name
path:
  v: DeviceDefinition.packaging.distributor.name
short:
  v: Distributor's human-readable name
definition:
  v: Distributor's human-readable name.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.packaging.distributor.name
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.distributor.organizationReference
path:
  v: DeviceDefinition.packaging.distributor.organizationReference
short:
  v: Distributor as an Organization resource
definition:
  v: Distributor as an Organization resource.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.packaging.distributor.organizationReference
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization|5.0.0
    l: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier
short:
  v: Unique Device Identifier (UDI) Barcode string on the packaging
definition:
  v: Unique Device Identifier (UDI) Barcode string on the packaging.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.packaging.udiDeviceIdentifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
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  key:
    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
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  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.id
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
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    v: 0
  max:
    v: 1
type:
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      v: string
      l: string
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    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.extension
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
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  v: user content
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max:
  v: *
base:
  path:
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type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
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    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
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is summary:
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mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
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alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier
short:
  v: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
definition:
  v: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-120|Package UDI-DI
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Package DI Number

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.issuer
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.issuer
short:
  v: The organization that assigns the identifier algorithm
definition:
  v: Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include: 1. GS1 GTIN: urn:oid:1.3.160, 2. HIBCC: urn:oid:2.16.840.1.113883.6.40, 3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18, 4. ICCBBA for other devices: to be found, 5. IFA (Europe Union only): to be found
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.issuer
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
short:
  v: The jurisdiction to which the deviceIdentifier applies
definition:
  v: The jurisdiction to which the deviceIdentifier applies.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.jurisdiction
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: urn:oid:2.16.840.1.113883.3.150

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution
short:
  v: Indicates whether and when the device is available on the market
definition:
  v: Indicates where and when the device is available on the market.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod
short:
  v: Begin and end dates for the commercial distribution of the device
definition:
  v: Begin and end dates for the commercial distribution of the device.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Period
    l: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start
short:
  v: Starting time with inclusive boundary
definition:
  v: The start of the period. The boundary is inclusive.
comment:
  v: If the low element is missing, the meaning is that the low boundary is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Period.start
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
condition:
  v: per-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: DR.1
mapping:
  identity:
    v: rim
  map:
    v: ./low

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end
short:
  v: End time with inclusive boundary, if not ongoing
definition:
  v: The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
comment:
  v: The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Period.end
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
meaning when missing:
  v: If the end of the period is missing, it means that the period is ongoing
condition:
  v: per-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: Package Discontinue Date
mapping:
  identity:
    v: v2
  map:
    v: DR.2
mapping:
  identity:
    v: rim
  map:
    v: ./high

id:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction
path:
  v: DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction
short:
  v: National state or territory where the device is commercialized
definition:
  v: National state or territory to which the marketDistribution recers, typically where the device is commercialized.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: urn:oid:2.16.840.1.113883.3.150

id:
  v: DeviceDefinition.packaging.packaging
path:
  v: DeviceDefinition.packaging.packaging
short:
  v: Allows packages within packages
definition:
  v: Allows packages within packages.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.packaging.packaging
  min:
    v: 0
  max:
    v: *
content reference:
  v: http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.packaging
  l: DeviceDefinition.packaging
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.version
path:
  v: DeviceDefinition.version
short:
  v: The version of the device or software
definition:
  v: The version of the device or software.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.version
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.version.id
path:
  v: DeviceDefinition.version.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.version.extension
path:
  v: DeviceDefinition.version.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.version.modifierExtension
path:
  v: DeviceDefinition.version.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.version.type
path:
  v: DeviceDefinition.version.type
short:
  v: The type of the device version, e.g. manufacturer, approved, internal
definition:
  v: The type of the device version, e.g. manufacturer, approved, internal.
alias:
  v: Σ
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.version.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.version.component
path:
  v: DeviceDefinition.version.component
short:
  v: The hardware or software module of the device to which the version applies
definition:
  v: The hardware or software module of the device to which the version applies.
comment:
  v: Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.version.component
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
    l: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]

id:
  v: DeviceDefinition.version.value
path:
  v: DeviceDefinition.version.value
short:
  v: The version text
definition:
  v: The version text.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.version.value
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.safety
path:
  v: DeviceDefinition.safety
short:
  v: Safety characteristics of the device
definition:
  v: Safety characteristics of the device.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.safety
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Safety
  strength:
    v: example
  value set:
    v: http://hl7.org/fhir/ValueSet/device-safety|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-safety
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices}; FLD-UDID-156|Containing latex (Boolean)
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: What MRI safety information does the labeling contain?; Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437); Device labeled as 'Not made with natural rubber latex'

id:
  v: DeviceDefinition.shelfLifeStorage
path:
  v: DeviceDefinition.shelfLifeStorage
short:
  v: Shelf Life and storage information
definition:
  v: Shelf Life and storage information.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.shelfLifeStorage
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: ProductShelfLife
    l: ProductShelfLife
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.languageCode
path:
  v: DeviceDefinition.languageCode
short:
  v: Language code for the human-readable text strings produced by the device (all supported)
definition:
  v: Language code for the human-readable text strings produced by the device (all supported).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.languageCode
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.property
path:
  v: DeviceDefinition.property
short:
  v: Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
definition:
  v: Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.
comment:
  v: Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-16|Risk Class; FLD-UDID-18|Animal tissues (Boolean); FLD-UDID-34|Microbial origin (Boolean); FLD-UDID-23|Human tissues (Boolean); FLD-UDID-28|Active Device (Boolean); FLD-UDID-29|Administer/Remove medicinal product (Boolean); FLD-UDID-30|Implantable (Boolean); FLD-UDID-31|Measuring Function (Boolean); FLD-UDID-32|Reusable Surgical Instruments (Boolean); FLD-UDID-33|Companion Diagnostic (Boolean); FLD-UDID-35|Near Patient Testing (Boolean); FLD-UDID-36|Patient Self Testing (Boolean); FLD-UDID-155|Medicinal product from blood/plasma (Boolean); FLD-UDID-158|Medicinal product (Boolean); FLD-UDID-262|Reagent (Boolean); FLD-UDID-263|Professional Testing (Boolean); FLD-UDID-264|Instrument (Boolean); FLD-UDID-356|Kit (Boolean); FLD-UDID-12|Device/Procedure pack/System; FLD-UDID-167|Single use (Boolean); FLD-UDID-169|Sterile; FLD-UDID-170|Sterilisation before use; FLD-UDID-146|Clinical Sizes; Handling Environment Temperature
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: For Single-Use; Prescription Use (Rx); Over the Counter (OTC); Kit; Combination Product; Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P); Device Packaged as Sterile; Requires Sterilization Prior to Use; Storage Environment Temperature; Handling Environment Temperature; Size - Length; Size - Width; Size - Heigth; Size - Angle

id:
  v: DeviceDefinition.property.id
path:
  v: DeviceDefinition.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.property.extension
path:
  v: DeviceDefinition.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.property.modifierExtension
path:
  v: DeviceDefinition.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: DeviceDefinition.property.type
path:
  v: DeviceDefinition.property.type
short:
  v: Code that specifies the property being represented
definition:
  v: Code that specifies the property such as a resolution or color being represented.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: DevicePropertyType
  strength:
    v: example
  description:
    v: Device property type.
  value set:
    v: http://hl7.org/fhir/ValueSet/device-property-type|5.0.0
    l: http://hl7.org/fhir/ValueSet/device-property-type

id:
  v: DeviceDefinition.property.value[x]
path:
  v: DeviceDefinition.property.value[x]
short:
  v: Value of the property
definition:
  v: The value of the property specified by the associated property.type code.
comment:
  v: This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: DeviceDefinition.property.value[x]
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Quantity
    l: Quantity
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
type:
  code:
    v: string
    l: string
type:
  code:
    v: boolean
    l: boolean
type:
  code:
    v: integer
    l: integer
type:
  code:
    v: Range
    l: Range
type:
  code:
    v: Attachment
    l: Attachment
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.owner
path:
  v: DeviceDefinition.owner
short:
  v: Organization responsible for device
definition:
  v: An organization that is responsible for the provision and ongoing maintenance of the device.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DeviceDefinition.owner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization|5.0.0
    l: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.source
mapping:
  identity:
    v: rim
  map:
    v: .playedRole[typeCode=OWN].scoper

id:
  v: DeviceDefinition.contact
path:
  v: DeviceDefinition.contact
short:
  v: Details for human/organization for support
definition:
  v: Contact details for an organization or a particular human that is responsible for the device.
comment:
  v: used for troubleshooting etc.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.contact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: ContactPoint
    l: ContactPoint
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: devicedefinition-to-eudamed
  map:
    v: FLD-UDID-354|Contact Details
mapping:
  identity:
    v: devicedefinition-to-gudid
  map:
    v: CUSTOMER CONTACT
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.source
mapping:
  identity:
    v: rim
  map:
    v: .scopedRole[typeCode=CON].player

id:
  v: DeviceDefinition.link
path:
  v: DeviceDefinition.link
short:
  v: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
definition:
  v: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DeviceDefinition.link
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: DeviceDefinition.link.id
path:
  v: DeviceDefinition.link.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: DeviceDefinition.link.extension
path:
  v: DeviceDefinition.link.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element