R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Medicinalproductdevicespec-example.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Not linked to any defined compartments

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

Jump past Narrative

Example of medicinalproductdevicespec (id = "example")

<?xml version="1.0" encoding="UTF-8"?>

<MedicinalProductDeviceSpec xmlns="http://hl7.org/fhir">
  <id value="example"/> 
  <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><p> <b> Generated Narrative with Details</b> </p> <p> <b> id</b> : example</p> <p> <b> identifier</b> : Device.DeviceIdentifier.extension</p> <p> <b> type</b> : {Device.DeviceType} <span> (Details : {http://ema.europa.eu/example/deviceType code '{Device.DeviceType}' = '{Device.DeviceType
          })</span> </p> <p> <b> tradeName</b> : Device Trade Name</p> <p> <b> quantity</b> : 2 1</p> <p> <b> listingNumber</b> : Device.DeviceListingNumber</p> <p> <b> modelNumber</b> : Device.ModelNumber</p> <p> <b> sterilityIndicator</b> : {Device.SterilityIndicator} <span> (Details : {http://ema.europa.eu/example/deviceSterilityIndicator code '{Device.SterilityIndicator}'
           = '{Device.SterilityIndicator})</span> </p> <p> <b> sterilisationRequirement</b> : {Device.SterilisationRequirementIndicator} <span> (Details : {http://ema.europa.eu/example/deviceSterilisationRequirementIndicator code
           '{Device.SterilisationRequirementIndicator}' = '{Device.SterilisationRequirementIndicator})</span> </p> <p> <b> usage</b> : {Device.DeviceUsage} <span> (Details : {http://ema.europa.eu/example/deviceUsage code '{Device.DeviceUsage}' = '{Device.DeviceUs
          age})</span> </p> <p> <b> nomenclature</b> : {DeviceNomenclature.NomenclatureValue} <span> (Details : {http://ema.europa.eu/example/deviceNomenclatureNomenclature code '{DeviceNomenclature.No
          menclatureValue}' = '{DeviceNomenclature.NomenclatureValue})</span> </p> <p> <b> physicalCharacteristics</b> : </p> <p> <b> Exception generating Narrative: Unknown type ProdCharacteristic</b> </p> </div> </text> <identifier> 
    <system value="http://ema.europa.eu/example/DeviceDeviceIdentifierRoot"/> 
    <value value="Device.DeviceIdentifier.extension"/> 
  </identifier> 
  <type> 
    <coding> 
      <system value="http://ema.europa.eu/example/deviceType"/> 
      <code value="{Device.DeviceType}"/> 
    </coding> 
  </type> 
  <tradeName value="Device Trade Name"/> 
  <quantity> 
    <value value="2"/> 
    <unit value="1"/> 
  </quantity> 
  <listingNumber value="Device.DeviceListingNumber"/> 
  <modelNumber value="Device.ModelNumber"/> 
  <sterilityIndicator> 
    <coding> 
      <system value="http://ema.europa.eu/example/deviceSterilityIndicator"/> 
      <code value="{Device.SterilityIndicator}"/> 
    </coding> 
  </sterilityIndicator> 
  <sterilisationRequirement> 
    <coding> 
      <system value="http://ema.europa.eu/example/deviceSterilisationRequirementIndicator"/> 
      <code value="{Device.SterilisationRequirementIndicator}"/> 
    </coding> 
  </sterilisationRequirement> 
  <usage> 
    <coding> 
      <system value="http://ema.europa.eu/example/deviceUsage"/> 
      <code value="{Device.DeviceUsage}"/> 
    </coding> 
  </usage> 
  <nomenclature> 
    <coding> 
      <system value="http://ema.europa.eu/example/deviceNomenclatureNomenclature"/> 
      <code value="{DeviceNomenclature.NomenclatureValue}"/> 
    </coding> 
  </nomenclature> 
  <physicalCharacteristics> 
    <height> 
      <value value="99"/> 
      <unit value="mm"/> 
    </height> 
    <width> 
      <value value="100"/> 
      <unit value="mm"/> 
    </width> 
    <depth> 
      <value value="10"/> 
      <unit value="mm"/> 
    </depth> 
    <weight> 
      <value value="100"/> 
      <unit value="g"/> 
    </weight> 
    <nominalVolume> 
      <value value="100"/> 
      <unit value="cm3"/> 
    </nominalVolume> 
    <externalDiameter> 
      <value value="100"/> 
      <unit value="mm"/> 
    </externalDiameter> 
    <shape value="{PhysicalCharacteristic.Shape}"/> 
    <color value="{PhysicalCharacteristic.Colour}"/> 
    <imprint value="{PhysicalCharacteristic.Imprint}"/> 
    <!--    image commented out - it needs content type but none seem available    -->
    <!--   image>
          <data value="e1BoeXNpY2FsQ2hhcmFjdGVyaXN0aWMuSW1hZ2V9"/>
        </image   -->
    <scoring> 
      <coding> 
        <system value="http://ema.europa.eu/example/physicalCharacteristicScoring"/> 
        <code value="{PhysicalCharacteristic.Scoring}"/> 
      </coding> 
    </scoring> 
  </physicalCharacteristics> 
  <batchIdentifier> 
    <value value="Device-BatchNumber"/> 
    <period> 
      <end value="2020-02-02"/> 
    </period> 
  </batchIdentifier> 
  <material> 
    <substance> 
      <coding> 
        <system value="http://ema.europa.eu/example/deviceMaterial"/> 
        <code value="{Device.Material}"/> 
      </coding> 
    </substance> 
    <alternate value="true"/> 
    <allergenicIndicator value="false"/> 
  </material> 
  <material> 
    <substance> 
      <coding> 
        <system value="http://ema.europa.eu/example/deviceMaterial"/> 
        <code value="{Device.Material}"/> 
      </coding> 
    </substance> 
    <alternate value="false"/> 
    <allergenicIndicator value="true"/> 
  </material> 
</MedicinalProductDeviceSpec> 

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.