MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build

MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions

: Device Class - TTL Representation

Active as of 2026-09-29

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

<http://hl7.org/fhir/CodeSystem/DeviceClass> a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:Resource.id [ fhir:value "DeviceClass"] ;
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ] ;
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem DeviceClass</b></p><a name=\"DeviceClass\"> </a><a name=\"hcDeviceClass\"> </a><p>This case-sensitive code system <code>http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass</code> defines the following codes in a Is-A hierarchy:</p><table class=\"codes\"><tr><td><b>Lvl</b></td><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td><td><b>Deutsch (German, de)</b></td></tr><tr><td>1</td><td style=\"white-space:nowrap\">I<a name=\"DeviceClass-I\"> </a></td><td>class I</td><td>class I (low risk)</td><td>Klasse I</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">II<a name=\"DeviceClass-II\"> </a></td><td>class II</td><td>class II (moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">  IIa<a name=\"DeviceClass-IIa\"> </a></td><td>class IIa</td><td>class IIa (low to moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">  IIb<a name=\"DeviceClass-IIb\"> </a></td><td>class IIb</td><td>class IIb (moderate to high risk)</td><td>Klasse II</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">III<a name=\"DeviceClass-III\"> </a></td><td>class III</td><td>class III (high risk)</td><td>Klasse III</td></tr></table></div>"
  ] ;
  fhir:CodeSystem.url [ fhir:value "http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass"] ;
  fhir:CodeSystem.identifier [
     fhir:index 0 ;
     fhir:Identifier.system [ fhir:value "urn:ietf:rfc:3986" ] ;
     fhir:Identifier.value [ fhir:value "urn:oid:1.2.3.4.5.6.7.8.9.9" ]
  ] ;
  fhir:CodeSystem.version [ fhir:value "0.4.3"] ;
  fhir:CodeSystem.name [ fhir:value "DeviceClassCS"] ;
  fhir:CodeSystem.title [ fhir:value "Device Class"] ;
  fhir:CodeSystem.status [ fhir:value "active"] ;
  fhir:CodeSystem.experimental [ fhir:value "true"^^xsd:boolean] ;
  fhir:CodeSystem.date [ fhir:value "2026-09-29T20:54:24+00:00"^^xsd:dateTime] ;
  fhir:CodeSystem.publisher [ fhir:value "HL7 Europe"] ;
  fhir:CodeSystem.contact [
     fhir:index 0 ;
     fhir:ContactDetail.name [ fhir:value "HL7 Europe" ] ;
     fhir:ContactDetail.telecom [
       fhir:index 0 ;
       fhir:ContactPoint.system [ fhir:value "url" ] ;
       fhir:ContactPoint.value [ fhir:value "http://www.hl7europe.org" ]
     ]
  ] ;
  fhir:CodeSystem.description [ fhir:value "Medical devices are categorized based on their risk level, \ninvasiveness, and duration of contact with the body. \nRegulatory bodies, such as the FDA in the US and authorities under the EU MDR."] ;
  fhir:CodeSystem.caseSensitive [ fhir:value "true"^^xsd:boolean] ;
  fhir:CodeSystem.hierarchyMeaning [ fhir:value "is-a"] ;
  fhir:CodeSystem.compositional [ fhir:value "false"^^xsd:boolean] ;
  fhir:CodeSystem.content [ fhir:value "complete"] ;
  fhir:CodeSystem.count [ fhir:value "5"^^xsd:nonNegativeInteger] ;
  fhir:CodeSystem.concept [
     fhir:index 0 ;
     fhir:CodeSystem.concept.code [ fhir:value "I" ] ;
     fhir:CodeSystem.concept.display [ fhir:value "class I" ] ;
     fhir:CodeSystem.concept.definition [ fhir:value "class I (low risk)" ] ;
     fhir:CodeSystem.concept.designation [
       fhir:index 0 ;
       fhir:CodeSystem.concept.designation.language [ fhir:value "de" ] ;
       fhir:CodeSystem.concept.designation.value [ fhir:value "Klasse I" ]
     ]
  ], [
     fhir:index 1 ;
     fhir:CodeSystem.concept.code [ fhir:value "II" ] ;
     fhir:CodeSystem.concept.display [ fhir:value "class II" ] ;
     fhir:CodeSystem.concept.definition [ fhir:value "class II (moderate risk)" ] ;
     fhir:CodeSystem.concept.designation [
       fhir:index 0 ;
       fhir:CodeSystem.concept.designation.language [ fhir:value "de" ] ;
       fhir:CodeSystem.concept.designation.value [ fhir:value "Klasse II" ]
     ] ;
     fhir:CodeSystem.concept.concept [
       fhir:index 0 ;
       fhir:CodeSystem.concept.code [ fhir:value "IIa" ] ;
       fhir:CodeSystem.concept.display [ fhir:value "class IIa" ] ;
       fhir:CodeSystem.concept.definition [ fhir:value "class IIa (low to moderate risk)" ] ;
       fhir:CodeSystem.concept.designation [
         fhir:index 0 ;
         fhir:CodeSystem.concept.designation.language [ fhir:value "de" ] ;
         fhir:CodeSystem.concept.designation.value [ fhir:value "Klasse II" ]
       ]
     ], [
       fhir:index 1 ;
       fhir:CodeSystem.concept.code [ fhir:value "IIb" ] ;
       fhir:CodeSystem.concept.display [ fhir:value "class IIb" ] ;
       fhir:CodeSystem.concept.definition [ fhir:value "class IIb (moderate to high risk)" ] ;
       fhir:CodeSystem.concept.designation [
         fhir:index 0 ;
         fhir:CodeSystem.concept.designation.language [ fhir:value "de" ] ;
         fhir:CodeSystem.concept.designation.value [ fhir:value "Klasse II" ]
       ]
     ]
  ], [
     fhir:index 2 ;
     fhir:CodeSystem.concept.code [ fhir:value "III" ] ;
     fhir:CodeSystem.concept.display [ fhir:value "class III" ] ;
     fhir:CodeSystem.concept.definition [ fhir:value "class III (high risk)" ] ;
     fhir:CodeSystem.concept.designation [
       fhir:index 0 ;
       fhir:CodeSystem.concept.designation.language [ fhir:value "de" ] ;
       fhir:CodeSystem.concept.designation.value [ fhir:value "Klasse III" ]
     ]
  ] .

# - ontology header ------------------------------------------------------------

<http://hl7.org/fhir/CodeSystem/DeviceClass.ttl> a owl:Ontology ;
  owl:imports fhir:fhir.ttl ;
  owl:versionIRI <http://build.fhir.org/CodeSystem/DeviceClass.ttl> .