Current Build

Extension-device-din.xml

Orders and Observations Work GroupMaturity Level: N/ABallot Status: Informative

Raw XML (canonical form + also see XML Format Specification)

din

<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="device-din"/> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="oo"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/StructureDefinition/device-din"/> 
  <name value="din"/> 
  <title value="Donation Identification Number (DIN)"/> 
  <status value="draft"/> 
  <date value="2015-02-21"/> 
  <publisher value="Health Level Seven, Inc. - FHIR WG"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="HL7"/> 
    </telecom> 
  </contact> 
  <description value="The distinct identification code required by §1271.290(c) for a human cell, tissue, or
   cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional,
   variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.
  fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm).
     If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to
   use for the system is:  http://hl7.org/fhir/NamingSystem/iccbba-din.  GS1 and HIBCC formatted
   UDIs do not currently convey the DIN element.

*Note to balloters: The Orders and Observations Workgroup has not yet determined whether
   the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.)
   and so the need for Donation Identification number is currently being met through this
   extension.  If it is determined a separate resource is to be used for Devices of Human
   (or other) Origin (tissue, blood, etc.)  then this extension may be deprecated in the
   future.  Feedback on this issue is welcome."/> 
  <fhirVersion value="3.4.0"/> 
  <mapping> 
    <identity value="rim"/> 
    <uri value="http://hl7.org/v3"/> 
    <name value="RIM Mapping"/> 
  </mapping> 
  <kind value="complex-type"/> 
  <abstract value="false"/> 
  <context> 
    <type value="element"/> 
    <expression value="Device"/> 
  </context> 
  <type value="Extension"/> 
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
  <derivation value="constraint"/> 
  <snapshot> 
    <element id="Extension">
      <path value="Extension"/> 
      <short value="DIN | DIC | Distinct Idendification Code"/> 
      <definition value="The distinct identification code required by §1271.290(c) for a human cell, tissue, or
       cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional,
       variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.
      fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm).
         If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to
       use for the system is:  http://hl7.org/fhir/NamingSystem/iccbba-din.  GS1 and HIBCC formatted
       UDIs do not currently convey the DIN element.

*Note to balloters: The Orders and Observations Workgroup has not yet determined whether
       the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.)
       and so the need for Donation Identification number is currently being met through this
       extension.  If it is determined a separate resource is to be used for Devices of Human
       (or other) Origin (tissue, blood, etc.)  then this extension may be deprecated in the
       future.  Feedback on this issue is welcome."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <condition value="ele-1"/> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> 
        <source value="Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
    </element> 
    <element id="Extension.id">
      <path value="Extension.id"/> 
      <representation value="xmlAttr"/> 
      <short value="xml:id (or equivalent in JSON)"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may be any
       string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="Extension.extension">
      <path value="Extension.extension"/> 
      <slicing> 
        <discriminator> 
          <type value="value"/> 
          <path value="url"/> 
        </discriminator> 
        <description value="Extensions are always sliced by (at least) url"/> 
        <rules value="open"/> 
      </slicing> 
      <short value="Extension"/> 
      <definition value="An Extension"/> 
      <min value="0"/> 
      <max value="0"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="Extension.url">
      <path value="Extension.url"/> 
      <representation value="xmlAttr"/> 
      <short value="identifies the meaning of the extension"/> 
      <definition value="Source of the definition for the extension code - a logical name or a URL."/> 
      <comment value="The definition may point directly to a computable or human-readable definition of the
       extensibility codes, or it may be a logical URI as declared in some other specification.
       The definition SHALL be a URI for the Structure Definition defining the extension."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        <path value="Extension.url"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="uri"/> 
      </type> 
      <fixedUri value="http://hl7.org/fhir/StructureDefinition/device-din"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="Extension.valueIdentifier">
      <path value="Extension.valueIdentifier"/> 
      <short value="Value of extension"/> 
      <definition value="Value of extension - may be a resource or one of a constrained set of the data types (see
       Extensibility in the spec for list)."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Extension.value[x]"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Identifier"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
  </snapshot> 
  <differential> 
    <element id="Extension">
      <path value="Extension"/> 
      <short value="DIN | DIC | Distinct Idendification Code"/> 
      <definition value="The distinct identification code required by §1271.290(c) for a human cell, tissue, or
       cellular and tissue-based product (HCT/P) regulated as a device - which is a conditional,
       variable portion of the production identifier (PI) of a [Unique device Identifier (UDI)](http://www.
      fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm).
         If the content is from an [ICCBBA](https://www.iccbba.org/)-encoded UDI, the URI to
       use for the system is:  http://hl7.org/fhir/NamingSystem/iccbba-din.  GS1 and HIBCC formatted
       UDIs do not currently convey the DIN element.

*Note to balloters: The Orders and Observations Workgroup has not yet determined whether
       the Device resource will include Devices of Human (or other) Origin (tissue, blood, etc.)
       and so the need for Donation Identification number is currently being met through this
       extension.  If it is determined a separate resource is to be used for Devices of Human
       (or other) Origin (tissue, blood, etc.)  then this extension may be deprecated in the
       future.  Feedback on this issue is welcome."/> 
      <min value="0"/> 
      <max value="1"/> 
    </element> 
    <element id="Extension.extension">
      <path value="Extension.extension"/> 
      <max value="0"/> 
    </element> 
    <element id="Extension.url">
      <path value="Extension.url"/> 
      <type> 
        <code value="uri"/> 
      </type> 
      <fixedUri value="http://hl7.org/fhir/StructureDefinition/device-din"/> 
    </element> 
    <element id="Extension.valueIdentifier">
      <path value="Extension.valueIdentifier"/> 
      <type> 
        <code value="Identifier"/> 
      </type> 
    </element> 
  </differential> 
</StructureDefinition> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.