Implementation Guide
TI Common
Version 1.5.0-ballot.1 - ballot

Ressourcenprofil: TI DeviceDefinition LaboratoryAnalyzer - Detaillierte Beschreibungen

Active Stand: 2026-11-16

Definitionen für das ti-device-definition-laboratory-analyzer ressourcenprofil

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

0. DeviceDefinition
Definition

Dieses Profil bildet das Modell eines Laboranalysegerätes ab.


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

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

For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. DeviceDefinition.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
This element is affected by the following invariants: ele-1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DeviceDefinition.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

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

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

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

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

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

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on DeviceDefinition.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 12. DeviceDefinition.manufacturer[x]
    Definition

    Hier wird der Name des Herstellers des Laboranalysegerätes angegeben.


    A name of the manufacturer.

    ShortName of device manufacturer
    Control0..1
    This element is affected by the following invariants: ele-1
    Typestring, Reference(Organization)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. DeviceDefinition.type
    Definition

    Kategorisierung des Laboranalysegerätes


    What kind of device or device system this is.

    ShortWhat kind of device or device system this is
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control0..1
    This element is affected by the following invariants: ele-1
    BindingFor example codes, see FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kind|4.0.1
    (example to http://hl7.org/fhir/ValueSet/device-kind|4.0.1)

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

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. DeviceDefinition.type.coding
    Definition

    Hier wird ein Code erfasst, welcher angibt um welchen Gerätetyp es sich handelt.


    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. 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.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeCoding
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. DeviceDefinition.type.coding.system
    Definition

    The identification of the code system that defines the meaning of the symbol in the code.

    ShortIdentity of the terminology system
    Comments

    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 reference to some definition that establishes the system clearly and unambiguously.

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

    Need to be unambiguous about the source of the definition of the symbol.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. DeviceDefinition.type.coding.version
    Definition

    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.

    ShortVersion of the system - if relevant
    Comments

    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.

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

    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).

    ShortSymbol in syntax defined by the system
    Control0..1
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Need to refer to a particular code in the system.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. DeviceDefinition.type.coding.display
    Definition

    A representation of the meaning of the code in the system, following the rules of the system.

    ShortRepresentation defined by the system
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

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

    Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

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

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

    0. DeviceDefinition
    Definition

    Dieses Profil bildet das Modell eines Laboranalysegerätes ab.

    2. DeviceDefinition.meta
    Must Supporttrue
    4. DeviceDefinition.meta.versionId
    Must Supporttrue
    6. DeviceDefinition.meta.lastUpdated
    Must Supporttrue
    8. DeviceDefinition.manufacturer[x]
    Definition

    Hier wird der Name des Herstellers des Laboranalysegerätes angegeben.

    Typestring, Reference(Organization)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    10. DeviceDefinition.type
    Definition

    Kategorisierung des Laboranalysegerätes

    Must Supporttrue
    12. DeviceDefinition.type.coding
    Definition

    Hier wird ein Code erfasst, welcher angibt um welchen Gerätetyp es sich handelt.

    Must Supporttrue
    14. DeviceDefinition.type.coding.system
    Must Supporttrue
    16. DeviceDefinition.type.coding.version
    NoteThis is a business version Id, not a resource version Id (see discussion)
    Must Supporttrue
    18. DeviceDefinition.type.coding.code
    Must Supporttrue
    20. DeviceDefinition.type.coding.display
    Must Supporttrue

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

    0. DeviceDefinition
    Definition

    Dieses Profil bildet das Modell eines Laboranalysegerätes ab.

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

    For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

    Control0..*
    Is Modifierfalse
    Summaryfalse
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    2. DeviceDefinition.id
    Definition

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

    ShortLogical id of this artifact
    Comments

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

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

    The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

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

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

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

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on DeviceDefinition.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 10. DeviceDefinition.meta.versionId
      Definition

      The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

      ShortVersion specific identifier
      Comments

      The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

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

      When the resource last changed - e.g. when the version changed.

      ShortWhen the resource version last changed
      Comments

      This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

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

      A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

      ShortIdentifies where the resource comes from
      Comments

      In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

      This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

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

      A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

      ShortProfiles this resource claims to conform to
      Comments

      It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

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

      Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

      ShortSecurity Labels applied to this resource
      Comments

      The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

      Control0..*
      This element is affected by the following invariants: ele-1
      BindingUnless not suitable, these codes SHALL be taken from All Security Labels
      (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

      Security Labels from the Healthcare Privacy and Security Classification System.

      TypeCoding
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. DeviceDefinition.meta.tag
      Definition

      Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

      ShortTags applied to this resource
      Comments

      The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

      Control0..*
      This element is affected by the following invariants: ele-1
      BindingFor example codes, see CommonTags
      (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

      Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

      TypeCoding
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. DeviceDefinition.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      ShortA set of rules under which this content was created
      Comments

      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

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

      The base language in which the resource is written.

      ShortLanguage of the resource content
      Comments

      Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

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

      A human language.

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

      A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

      ShortText summary of the resource, for human interpretation
      Comments

      Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

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

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

      ShortContained, inline Resources
      Comments

      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

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

      May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on DeviceDefinition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 32. DeviceDefinition.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

        ShortExtensions that cannot be ignored
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on DeviceDefinition.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 34. DeviceDefinition.identifier
          Definition

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

          ShortInstance identifier
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeIdentifier
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. DeviceDefinition.udiDeviceIdentifier
          Definition

          Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

          ShortUnique Device Identifier (UDI) Barcode string
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeBackboneElement
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. DeviceDefinition.udiDeviceIdentifier.id
          Definition

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

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

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on DeviceDefinition.udiDeviceIdentifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 42. DeviceDefinition.udiDeviceIdentifier.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            44. DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
            Definition

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

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

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control1..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            46. DeviceDefinition.udiDeviceIdentifier.issuer
            Definition

            The organization that assigns the identifier algorithm.

            ShortThe organization that assigns the identifier algorithm
            Comments

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

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

            The jurisdiction to which the deviceIdentifier applies.

            ShortThe jurisdiction to which the deviceIdentifier applies
            Comments

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

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

            Hier wird der Name des Herstellers des Laboranalysegerätes angegeben.

            ShortName of device manufacturer
            Control0..1
            This element is affected by the following invariants: ele-1
            Typestring
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            52. DeviceDefinition.deviceName
            Definition

            A name given to the device to identify it.

            ShortA name given to the device to identify it
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            Is Modifierfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            54. DeviceDefinition.deviceName.id
            Definition

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

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

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on DeviceDefinition.deviceName.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 58. DeviceDefinition.deviceName.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              60. DeviceDefinition.deviceName.name
              Definition

              The name of the device.

              ShortThe name of the device
              Comments

              Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

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

              The type of name the device is referred by.

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

              The model number for the device.

              ShortThe model number for the device
              Comments

              Note that FHIR strings SHALL NOT exceed 1MB in size

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

              Kategorisierung des Laboranalysegerätes

              ShortWhat kind of device or device system this is
              Comments

              Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

              Control0..1
              This element is affected by the following invariants: ele-1
              BindingFor example codes, see FHIRDeviceTypes
              (example to http://hl7.org/fhir/ValueSet/device-kind|4.0.1)

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

              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. DeviceDefinition.type.id
              Definition

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

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

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on DeviceDefinition.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 72. DeviceDefinition.type.coding
                Definition

                Hier wird ein Code erfasst, welcher angibt um welchen Gerätetyp es sich handelt.

                ShortCode defined by a terminology system
                Comments

                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. 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.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeCoding
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                Allows for alternative encodings within a code system, and translations to other code systems.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                74. DeviceDefinition.type.coding.id
                Definition

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

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

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on DeviceDefinition.type.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 78. DeviceDefinition.type.coding.system
                  Definition

                  The identification of the code system that defines the meaning of the symbol in the code.

                  ShortIdentity of the terminology system
                  Comments

                  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 reference to some definition that establishes the system clearly and unambiguously.

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

                  Need to be unambiguous about the source of the definition of the symbol.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  80. DeviceDefinition.type.coding.version
                  Definition

                  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.

                  ShortVersion of the system - if relevant
                  Comments

                  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.

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

                  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).

                  ShortSymbol in syntax defined by the system
                  Control0..1
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Need to refer to a particular code in the system.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  84. DeviceDefinition.type.coding.display
                  Definition

                  A representation of the meaning of the code in the system, following the rules of the system.

                  ShortRepresentation defined by the system
                  Comments

                  Note that FHIR strings SHALL NOT exceed 1MB in size

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

                  Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  86. DeviceDefinition.type.coding.userSelected
                  Definition

                  Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                  ShortIf this coding was chosen directly by the user
                  Comments

                  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.

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

                  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.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  88. DeviceDefinition.type.text
                  Definition

                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                  ShortPlain text representation of the concept
                  Comments

                  Very often the text is the same as a displayName of one of the codings.

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

                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

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

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

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

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

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on DeviceDefinition.specialization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 96. DeviceDefinition.specialization.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    98. DeviceDefinition.specialization.systemType
                    Definition

                    The standard that is used to operate and communicate.

                    ShortThe standard that is used to operate and communicate
                    Comments

                    Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

                    ShortThe version of the standard that is used to operate and communicate
                    Comments

                    Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

                    ShortAvailable versions
                    Comments

                    Note that FHIR strings SHALL NOT exceed 1MB in size

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

                    Safety characteristics of the device.

                    ShortSafety characteristics of the device
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    BindingFor example codes, see DeviceSafety
                    (example to http://hl7.org/fhir/ValueSet/device-safety|4.0.1)
                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    106. DeviceDefinition.shelfLifeStorage
                    Definition

                    Shelf Life and storage information.

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

                    Dimensions, color etc.

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

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

                    ShortLanguage code for the human-readable text strings produced by the device (all supported)
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    112. DeviceDefinition.capability
                    Definition

                    Device capabilities.

                    ShortDevice capabilities
                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeBackboneElement
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    114. DeviceDefinition.capability.id
                    Definition

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

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

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on DeviceDefinition.capability.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 118. DeviceDefinition.capability.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      120. DeviceDefinition.capability.type
                      Definition

                      Type of capability.

                      ShortType of capability
                      Comments

                      Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      TypeCodeableConcept
                      Is Modifierfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      122. DeviceDefinition.capability.description
                      Definition

                      Description of capability.

                      ShortDescription of capability
                      Comments

                      Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeCodeableConcept
                      Is Modifierfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      124. DeviceDefinition.property
                      Definition

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

                      ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
                      Control0..*
                      This element is affected by the following invariants: ele-1
                      TypeBackboneElement
                      Is Modifierfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      126. DeviceDefinition.property.id
                      Definition

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

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

                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on DeviceDefinition.property.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 130. DeviceDefinition.property.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        132. DeviceDefinition.property.type
                        Definition

                        Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

                        ShortCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
                        Comments

                        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                        Control1..1
                        This element is affected by the following invariants: ele-1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        134. DeviceDefinition.property.valueQuantity
                        Definition

                        Property value as a quantity.

                        ShortProperty value as a quantity
                        Comments

                        The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeQuantity
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                        136. DeviceDefinition.property.valueCode
                        Definition

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

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

                        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        138. DeviceDefinition.owner
                        Definition

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

                        ShortOrganization responsible for device
                        Comments

                        References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeReference(Organization)
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        140. DeviceDefinition.contact
                        Definition

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

                        ShortDetails for human/organization for support
                        Comments

                        used for troubleshooting etc.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeContactPoint
                        Is Modifierfalse
                        Invariantscpt-2: A system is required if a value is provided. (value.empty() or system.exists())
                        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        142. DeviceDefinition.url
                        Definition

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

                        ShortNetwork address to contact device
                        Comments

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

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

                        Access to on-line information about the device.

                        ShortAccess to on-line information
                        Comments

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

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

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

                        ShortDevice notes and comments
                        Comments

                        For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeAnnotation
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        148. DeviceDefinition.quantity
                        Definition

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

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

                        The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeQuantity
                        Is Modifierfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                        150. DeviceDefinition.parentDevice
                        Definition

                        The parent device it can be part of.

                        ShortThe parent device it can be part of
                        Comments

                        References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeReference(DeviceDefinition)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        152. DeviceDefinition.material
                        Definition

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

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

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

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

                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        ShortAdditional content defined by implementations
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on DeviceDefinition.material.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 158. DeviceDefinition.material.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          160. DeviceDefinition.material.substance
                          Definition

                          The substance.

                          ShortThe substance
                          Comments

                          Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                          Control1..1
                          This element is affected by the following invariants: ele-1
                          TypeCodeableConcept
                          Is Modifierfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          162. DeviceDefinition.material.alternate
                          Definition

                          Indicates an alternative material of the device.

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

                          Whether the substance is a known or suspected allergen.

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