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IKNL PZP STU3 - Local Development build (v0.1.3-beta3) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ACPMedicalDeviceProductICD - Detailed Descriptions

Draft as of 2025-08-28

Definitions for the ACP-MedicalDevice.Product-ICD resource profile.

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

0. Device
Definitie

The medical aid used (internally or externally).


This resource identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

KortProductItem used in healthcare
Control0..*
Alternatieve namenProduct
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
2. Device.implicitRules
Definitie

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

KortA set of rules under which this content was created
Opmerkingen

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

Control0..1
Typeuri
Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
Samenvattingtrue
4. Device.modifierExtension
Definitie

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. Usually modifier elements provide negation or qualification. In order 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.

KortExtensions that cannot be ignored
Opmerkingen

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 omdat No Modifier Reason provideed in previous versions of FHIR
Alternatieve namenextensions, user content
6. Device.identifier
Definitie

Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).


Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

KortProductIDInstance identifier
Opmerkingen

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.


The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
Control0..*
TypeIdentifier
Alternatieve namenSerial Number, ProductID
SlicingDit element introduceert een set slices op Device.identifierDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
  • pattern @ type
  • 8. Device.identifier:serialNumber
    SlicenaamserialNumber
    Definitie

    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    Kortserial number (21) part of the UDIInstance identifier
    Opmerkingen

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.


    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    Control0..1*
    TypeIdentifier
    Alternatieve namenSerial Number
    10. Device.identifier:serialNumber.use
    Definitie

    The purpose of this identifier.

    Kortusual | official | temp | secondary (If known)
    Opmerkingen

    This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingDe codes MOETEN komen uit IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use
    (required to http://hl7.org/fhir/ValueSet/identifier-use|3.0.2)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    12. Device.identifier:serialNumber.type
    Definitie

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    KortDescription of identifier
    Opmerkingen

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

    Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control10..1
    BindingTenzij dat niet past, MOETEN deze codes worden gehaald uit Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type|3.0.2)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Samenvattingtrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Patroonwaarde{
      "coding" : [{
        "system" : "http://hl7.org/fhir/identifier-type",
        "code" : "SNO"
      }]
    }
    14. Device.identifier:serialNumber.type.coding
    Definitie

    A reference to a code defined by a terminology system.

    KortCode defined by a terminology system
    Opmerkingen

    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.

    Control10..1*
    TypeCoding
    Samenvattingtrue
    Requirements

    Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

    16. Device.identifier:serialNumber.type.coding.system
    Definitie

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

    KortIdentity of the terminology system
    Opmerkingen

    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 de-reference to some definition that establish the system clearly and unambiguously.

    Control10..1
    Typeuri
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    Requirements

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

    Vast waardehttp://hl7.org/fhir/identifier-type
    18. Device.identifier:serialNumber.type.coding.code
    Definitie

    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).

    KortSymbol in syntax defined by the system
    Control10..1
    Typecode
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    Requirements

    Need to refer to a particular code in the system.

    Vast waardeSNO
    20. Device.identifier:serialNumber.value
    Definitie

    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

    KortThe value that is unique
    Opmerkingen

    If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

    Control10..1
    Typestring
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    VoorbeeldGeneral: 123456
    22. Device.identifier:gs1ProductID
    Slicenaamgs1ProductID
    Definitie

    Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

    The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).


    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    KortProductIDInstance identifier
    Opmerkingen

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.


    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    Control0..*
    TypeIdentifier
    Alternatieve namenSerial Number, ProductID
    24. Device.identifier:hibcProductID
    SlicenaamhibcProductID
    Definitie

    Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

    The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).


    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    KortProductIDInstance identifier
    Opmerkingen

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.


    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    Control0..*
    TypeIdentifier
    Alternatieve namenSerial Number, ProductID
    26. Device.status
    Definitie

    Status of the Device availability.

    Kortactive | inactive | entered-in-error | unknown
    Opmerkingen

    This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

    Control0..1
    BindingDe codes MOETEN komen uit FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status
    (required to http://hl7.org/fhir/ValueSet/device-status|3.0.2)

    The availability status of the device.

    Typecode
    Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    28. Device.type
    Definitie

    The code of the type of product.


    Code or identifier to identify a kind of device.

    KortProductTypeWhat kind of device this is
    Control0..1
    BindingDe codes MOETEN komen uit Voor voorbeeldcodes, zie ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3)http://hl7.org/fhir/ValueSet/device-kind
    (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3)
    TypeCodeableConcept
    Alternatieve namenProductType

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

    0. Device
    2. Device.identifier:gs1ProductID
    Slicenaamgs1ProductID
    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    4. Device.identifier:hibcProductID
    SlicenaamhibcProductID
    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    6. Device.udi
    8. Device.udi.carrierHRF
    10. Device.type
    BindingDe codes MOETEN komen uit ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3)
    (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3)
    12. Device.note
    14. Device.note.text

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

    0. Device
    Definitie

    The medical aid used (internally or externally).

    KortProduct
    Control0..*
    Alternatieve namenProduct
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
    2. Device.id
    Definitie

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

    KortLogical id of this artifact
    Opmerkingen

    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
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    4. Device.meta
    Definitie

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

    KortMetadata about the resource
    Control0..1
    TypeMeta
    Samenvattingtrue
    6. Device.implicitRules
    Definitie

    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

    KortA set of rules under which this content was created
    Opmerkingen

    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.

    This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

    Control0..1
    Typeuri
    Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    Samenvattingtrue
    8. Device.language
    Definitie

    The base language in which the resource is written.

    KortLanguage of the resource content
    Opmerkingen

    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
    BindingTenzij dat niet past, MOETEN deze codes worden gehaald uit Common Languages
    (extensible to http://hl7.org/fhir/ValueSet/languages|3.0.2)

    A human language.

    Additionele bindingsDoel
    All LanguagesMax binding
    Typecode
    Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
    10. Device.text
    Definitie

    A human-readable narrative that contains a summary of the resource, and may 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.

    KortText summary of the resource, for human interpretation
    Opmerkingen

    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 in formation is added later.

    Control0..1
    Dit element wordt geraakt door de volgende invariants: dom-1
    TypeNarrative
    Alternatieve namennarrative, html, xhtml, display
    12. Device.contained
    Definitie

    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.

    KortContained, inline Resources
    Opmerkingen

    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.

    Control0..*
    TypeResource
    Alternatieve nameninline resources, anonymous resources, contained resources
    14. Device.extension
    Definitie

    May be used to represent additional information that is not part of the basic definition of the resource. In order 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.

    KortAdditional Content defined by implementations
    Opmerkingen

    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
    Alternatieve namenextensions, user content
    16. Device.modifierExtension
    Definitie

    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. Usually modifier elements provide negation or qualification. In order 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.

    KortExtensions that cannot be ignored
    Opmerkingen

    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 omdat No Modifier Reason provideed in previous versions of FHIR
    Alternatieve namenextensions, user content
    18. Device.identifier
    Definitie

    Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

    The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

    KortProductID
    Opmerkingen

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

    NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
    Control0..*
    TypeIdentifier
    Alternatieve namenSerial Number, ProductID
    SlicingDit element introduceert een set slices op Device.identifierDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
    • pattern @ type
    • 20. Device.identifier:serialNumber
      SlicenaamserialNumber
      Definitie

      Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

      Kortserial number (21) part of the UDI
      Opmerkingen

      The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

      NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
      Control0..1
      TypeIdentifier
      Alternatieve namenSerial Number
      22. Device.identifier:serialNumber.id
      Definitie

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

      Kortxml:id (or equivalent in JSON)
      Control0..1
      Typestring
      Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
      Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
      24. Device.identifier:serialNumber.extension
      Definitie

      May be used to represent additional information that is not part of the basic definition of the element. In order 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.

      KortAdditional Content defined by implementations
      Opmerkingen

      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
      Alternatieve namenextensions, user content
      SlicingDit element introduceert een set slices op Device.identifier.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
      • value @ url
      • 26. Device.identifier:serialNumber.use
        Definitie

        The purpose of this identifier.

        Kortusual | official | temp | secondary (If known)
        Opmerkingen

        This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

        Control0..1
        BindingDe codes MOETEN komen uit IdentifierUse
        (required to http://hl7.org/fhir/ValueSet/identifier-use|3.0.2)

        Identifies the purpose for this identifier, if known .

        Typecode
        Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
        Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
        Samenvattingtrue
        Requirements

        Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

        28. Device.identifier:serialNumber.type
        Definitie

        A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

        KortDescription of identifier
        Opmerkingen

        This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

        Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

        Control1..1
        BindingTenzij dat niet past, MOETEN deze codes worden gehaald uit Identifier Type Codes
        (extensible to http://hl7.org/fhir/ValueSet/identifier-type|3.0.2)

        A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

        TypeCodeableConcept
        Samenvattingtrue
        Requirements

        Allows users to make use of identifiers when the identifier system is not known.

        Patroonwaarde{
          "coding" : [{
            "system" : "http://hl7.org/fhir/identifier-type",
            "code" : "SNO"
          }]
        }
        30. Device.identifier:serialNumber.type.id
        Definitie

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

        Kortxml:id (or equivalent in JSON)
        Control0..1
        Typestring
        Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
        Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
        32. Device.identifier:serialNumber.type.extension
        Definitie

        May be used to represent additional information that is not part of the basic definition of the element. In order 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.

        KortAdditional Content defined by implementations
        Opmerkingen

        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
        Alternatieve namenextensions, user content
        SlicingDit element introduceert een set slices op Device.identifier.type.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
        • value @ url
        • 34. Device.identifier:serialNumber.type.coding
          Definitie

          A reference to a code defined by a terminology system.

          KortCode defined by a terminology system
          Opmerkingen

          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.

          Control1..1
          TypeCoding
          Samenvattingtrue
          Requirements

          Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

          36. Device.identifier:serialNumber.type.coding.id
          Definitie

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

          Kortxml:id (or equivalent in JSON)
          Control0..1
          Typestring
          Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
          Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
          38. Device.identifier:serialNumber.type.coding.extension
          Definitie

          May be used to represent additional information that is not part of the basic definition of the element. In order 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.

          KortAdditional Content defined by implementations
          Opmerkingen

          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
          Alternatieve namenextensions, user content
          SlicingDit element introduceert een set slices op Device.identifier.type.coding.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
          • value @ url
          • 40. Device.identifier:serialNumber.type.coding.system
            Definitie

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

            KortIdentity of the terminology system
            Opmerkingen

            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 de-reference to some definition that establish the system clearly and unambiguously.

            Control1..1
            Typeuri
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Requirements

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

            Vast waardehttp://hl7.org/fhir/identifier-type
            42. Device.identifier:serialNumber.type.coding.version
            Definitie

            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.

            KortVersion of the system - if relevant
            Opmerkingen

            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.

            NotitieDit is een business-versieidentifier, geen resource-versieidentifier (zie discussie)
            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            44. Device.identifier:serialNumber.type.coding.code
            Definitie

            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).

            KortSymbol in syntax defined by the system
            Control1..1
            Typecode
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Requirements

            Need to refer to a particular code in the system.

            Vast waardeSNO
            46. Device.identifier:serialNumber.type.coding.display
            Definitie

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

            KortRepresentation defined by the system
            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Requirements

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

            48. Device.identifier:serialNumber.type.coding.userSelected
            Definitie

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

            KortIf this coding was chosen directly by the user
            Opmerkingen

            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
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            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.

            50. Device.identifier:serialNumber.type.text
            Definitie

            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.

            KortPlain text representation of the concept
            Opmerkingen

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

            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            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.

            52. Device.identifier:serialNumber.system
            Definitie

            Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

            KortThe namespace for the identifier value
            Control0..1
            Typeuri
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Requirements

            There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

            VoorbeeldGeneral: http://www.acme.com/identifiers/patient
            54. Device.identifier:serialNumber.value
            Definitie

            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

            KortThe value that is unique
            Opmerkingen

            If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

            Control1..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            VoorbeeldGeneral: 123456
            56. Device.identifier:serialNumber.period
            Definitie

            Time period during which identifier is/was valid for use.

            KortTime period when id is/was valid for use
            Control0..1
            TypePeriod
            Samenvattingtrue
            58. Device.identifier:serialNumber.assigner
            Definitie

            Organization that issued/manages the identifier.

            KortOrganization that issued id (may be just text)
            Opmerkingen

            The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

            Control0..1
            TypeReference(Organization)
            Samenvattingtrue
            60. Device.identifier:gs1ProductID
            Slicenaamgs1ProductID
            Definitie

            Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

            The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

            KortProductID
            Opmerkingen

            The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

            NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
            Control0..*
            TypeIdentifier
            Alternatieve namenSerial Number, ProductID
            62. Device.identifier:hibcProductID
            SlicenaamhibcProductID
            Definitie

            Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

            The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

            KortProductID
            Opmerkingen

            The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

            NotitieDit is een business-identifier, geen resource-identifier (zie discussie)
            Control0..*
            TypeIdentifier
            Alternatieve namenSerial Number, ProductID
            64. Device.udi
            Definitie

            Unique device identifier (UDI) assigned to device label or package.

            KortUnique Device Identifier (UDI) Barcode string
            Opmerkingen

            UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

            Control0..1
            TypeBackboneElement
            Samenvattingtrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
            66. Device.udi.id
            Definitie

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

            Kortxml:id (or equivalent in JSON)
            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
            68. Device.udi.extension
            Definitie

            May be used to represent additional information that is not part of the basic definition of the element. In order 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.

            KortAdditional Content defined by implementations
            Opmerkingen

            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
            Alternatieve namenextensions, user content
            70. Device.udi.modifierExtension
            Definitie

            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 that contains it. Usually modifier elements provide negation or qualification. In order 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.

            KortExtensions that cannot be ignored
            Opmerkingen

            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 omdat No Modifier Reason provideed in previous versions of FHIR
            Samenvattingtrue
            Alternatieve namenextensions, user content, modifiers
            72. Device.udi.deviceIdentifier
            Definitie

            The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

            Kortapplication identifier (AI) (01) part of the udi
            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Alternatieve namenDI
            74. Device.udi.name
            Definitie

            Name of device as used in labeling or catalog.

            KortDevice Name as appears on UDI label
            Opmerkingen

            Use the Device.type for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.

            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Alternatieve namenBrand Name
            76. Device.udi.jurisdiction
            Definitie

            The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

            KortRegional UDI authority
            Control0..1
            Typeuri
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Requirements

            Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

            78. Device.udi.carrierHRF
            Definitie

            Unique identification of the product, such as the serial number.

            Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

            The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

            KortProductID
            Opmerkingen

            If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Alternatieve namenHuman Readable Form
            80. Device.udi.carrierAIDC
            Definitie

            The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

            KortUDI Machine Readable Barcode String
            Opmerkingen

            The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

            Control0..1
            Typebase64Binary
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            Alternatieve namenAutomatic Identification and Data Capture
            82. Device.udi.issuer
            Definitie

            Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.

            KortUDI Issuing Organization
            Control0..1
            Typeuri
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Alternatieve namenBarcode System
            84. Device.udi.entryType
            Definitie

            A coded entry to indicate how the data was entered.

            Kortbarcode | rfid | manual +
            Control0..1
            BindingDe codes MOETEN komen uit UDIEntryType
            (required to http://hl7.org/fhir/ValueSet/udi-entry-type|3.0.2)

            Codes to identify how UDI data was entered

            Typecode
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Requirements

            Supports a way to distinguish hand entered from machine read data.

            86. Device.status
            Definitie

            Status of the Device availability.

            Kortactive | inactive | entered-in-error | unknown
            Opmerkingen

            This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

            Control0..1
            BindingDe codes MOETEN komen uit FHIRDeviceStatus
            (required to http://hl7.org/fhir/ValueSet/device-status|3.0.2)

            The availability status of the device.

            Typecode
            Is modifiertrue omdat No Modifier Reason provideed in previous versions of FHIR
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Samenvattingtrue
            88. Device.type
            Definitie

            The code of the type of product.

            KortProductType
            Control0..1
            BindingDe codes MOETEN komen uit ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3)
            (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3)
            TypeCodeableConcept
            Alternatieve namenProductType
            90. Device.type.id
            Definitie

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

            Kortxml:id (or equivalent in JSON)
            Control0..1
            Typestring
            Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
            Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
            92. Device.type.extension
            Definitie

            May be used to represent additional information that is not part of the basic definition of the element. In order 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.

            KortAdditional Content defined by implementations
            Opmerkingen

            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
            Alternatieve namenextensions, user content
            SlicingDit element introduceert een set slices op Device.type.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
            • value @ url
            • 94. Device.type.coding
              Definitie

              A reference to a code defined by a terminology system.

              KortCode defined by a terminology system
              Opmerkingen

              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..*
              TypeCoding
              Samenvattingtrue
              Requirements

              Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

              96. Device.type.coding.id
              Definitie

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

              Kortxml:id (or equivalent in JSON)
              Control0..1
              Typestring
              Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
              Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
              98. Device.type.coding.extension
              Definitie

              May be used to represent additional information that is not part of the basic definition of the element. In order 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.

              KortAdditional Content defined by implementations
              Opmerkingen

              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
              Alternatieve namenextensions, user content
              SlicingDit element introduceert een set slices op Device.type.coding.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
              • value @ url
              • 100. Device.type.coding.system
                Definitie

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

                KortIdentity of the terminology system
                Opmerkingen

                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 de-reference to some definition that establish the system clearly and unambiguously.

                Control1..1
                Typeuri
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                Requirements

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

                102. Device.type.coding.version
                Definitie

                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.

                KortVersion of the system - if relevant
                Opmerkingen

                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.

                NotitieDit is een business-versieidentifier, geen resource-versieidentifier (zie discussie)
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                104. Device.type.coding.code
                Definitie

                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).

                KortSymbol in syntax defined by the system
                Control1..1
                Typecode
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                Requirements

                Need to refer to a particular code in the system.

                106. Device.type.coding.display
                Definitie

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

                KortRepresentation defined by the system
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                Requirements

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

                108. Device.type.coding.userSelected
                Definitie

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

                KortIf this coding was chosen directly by the user
                Opmerkingen

                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
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                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.

                110. Device.type.text
                Definitie

                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.

                KortPlain text representation of the concept
                Opmerkingen

                For LaboratoryTestResult.Specimen.SpecimenSource a device may be recorded as a subject of the Specimen. For example if the material is not collected directly from the patient but comes from a patient-related object, e.g. a catheter tip. This source of material can be recorded here.

                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Samenvattingtrue
                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.

                112. Device.lotNumber
                Definitie

                Lot number assigned by the manufacturer.

                Kortbatch or lot number (10) part of the UDI
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                114. Device.manufacturer
                Definitie

                A name of the manufacturer.

                KortName of device manufacturer
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                116. Device.manufactureDate
                Definitie

                The date and time when the device was manufactured.

                KortDate when the device was made
                Control0..1
                TypedateTime
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                118. Device.expirationDate
                Definitie

                The date and time beyond which this device is no longer valid or should not be used (if applicable).

                Kortexpiration date (17) part of the UDI
                Control0..1
                TypedateTime
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                120. Device.model
                Definitie

                The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.

                KortModel id assigned by the manufacturer
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                122. Device.version
                Definitie

                The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.

                KortVersion number (i.e. software)
                NotitieDit is een business-versieidentifier, geen resource-versieidentifier (zie discussie)
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                124. Device.patient
                Definitie

                Patient information, If the device is affixed to a person.

                KortPatient to whom Device is affixed
                Control0..1
                TypeReference(nl-core-patient)
                Requirements

                If the device is implanted in a patient, then need to associate the device to the patient.

                126. Device.owner
                Definitie

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

                KortOrganization responsible for device
                Control0..1
                TypeReference(nl-core-organization)
                128. Device.contact
                Definitie

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

                KortDetails for human/organization for support
                Opmerkingen

                used for troubleshooting etc.

                Control0..*
                TypeContactPoint
                130. Device.location
                Definitie

                The place where the device can be found.

                KortWhere the resource is found
                Control0..1
                TypeReference(nl-core-location)
                Requirements

                Device.location can be used to track device location.

                132. Device.url
                Definitie

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

                KortNetwork address to contact device
                Opmerkingen

                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
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                134. Device.note
                Definitie

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

                KortDevice notes and comments
                Control0..*
                TypeAnnotation
                136. Device.note.id
                Definitie

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

                Kortxml:id (or equivalent in JSON)
                Control0..1
                Typestring
                Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                Xml-formaatIn xml wordt dit attribuut gerepresenteerd als attribuut.
                138. Device.note.extension
                Definitie

                May be used to represent additional information that is not part of the basic definition of the element. In order 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.

                KortAdditional Content defined by implementations
                Opmerkingen

                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
                Alternatieve namenextensions, user content
                SlicingDit element introduceert een set slices op Device.note.extensionDe slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators:
                • value @ url
                • 140. Device.note.author[x]
                  Definitie

                  The individual responsible for making the annotation.

                  KortIndividual responsible for the annotation
                  Control0..1
                  TypeKeuze uit: Reference(Practitioner, Patient, RelatedPerson), string
                  [x] NoteZieKeuze uit datatypenvoor verdere informatie over hoe [x] te gebruiken
                  Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                  Samenvattingtrue
                  142. Device.note.time
                  Definitie

                  Indicates when this particular annotation was made.

                  KortWhen the annotation was made
                  Control0..1
                  TypedateTime
                  Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                  Samenvattingtrue
                  144. Device.note.text
                  Definitie

                  Textual description of the product.

                  KortProductDescription
                  Control1..1
                  Typestring
                  Primitieve waardeDit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie
                  Alternatieve namenProductOmschrijving
                  146. Device.safety
                  Definitie

                  Provides additional safety characteristics about a medical device. For example devices containing latex.

                  KortSafety Characteristics of Device
                  Control0..*
                  BindingVoor voorbeeldcodes, zie DeviceSafety
                  (example to http://hl7.org/fhir/ValueSet/device-safety|3.0.2)

                  Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations and are provided here as a suggestive example.

                  TypeCodeableConcept
                  Samenvattingtrue