MedTechLabel WP2 T2.2 Information Model Guide
0.4.15 - ci-build

MedTechLabel WP2 T2.2 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.15 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

ValueSet: Digital Label Element objects

Official URL: http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement4Object Version: 0.4.15
Active as of 2026-10-07 Computable Name: DigitalLabelElement4ObjectVS
Other Identifiers: OID:1.2.3.4.5.6.7.8.10.51

Copyright/Legal: FO

objects from Digital Label Elements

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

 

Expansion

Expansion performed internally based on codesystem Digital Label Element v0.4.15 (CodeSystem)

This value set contains 109 concepts

SystemCodeDisplay (en)InactiveDefinitionstatusJSONXML
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  objectany kind of objectinactivebasic information objects for our model; these must be represented in the information model as classesinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  physicalObjectphysical Objectan object that physically exists
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productproduct
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  medicalDevicemedical deviceinstrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for patients (3.29), for one or more of the specific medical purpose(s)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sparePartspart partspare part replacing whole or part of the original medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  batterybatterybattery providing electrical power to a medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  componentcomponentcomponent of the medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  detachableComponentdetachable componentdetachable component of the medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  accessoryaccessory
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  consumableComponentconsumable component
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  containercontainerbox containing the items
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagepackageouter container declared as the complete product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  organizationorganisationany kind of an organization being involved
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturermanufacturerorganisation that produces the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  distributordistributorwho distributes the product?
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  importerimporterorganization who imports a product that was manufactured in one locale into another locale for the purposes of marketing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingProducerpackaging producer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  conformityAssessmentOrgorganisation performing the conformity assessment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  eudamedEuropean Database on Medical Devices (EUDAMED)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  personPersonperson
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  naturalPersonnatural personnatural person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  jurisdictionalPersonjurisdictional personjurisdictional person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  authorizedRepresentativeauthorized representativeorganization established within a country or jurisdiction who has received a written mandate from the manufacturer to act on their behalf for specified tasks regarding the latter’s obligations under that country or jurisdiction’s legislation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  animalAnimalanimal
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  labelLabellabel for medicinal product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electronicLabelelectronic Labellabel in electronic format
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  digitalLabeldigital Labeldigital label, potentially misleading with its generic meaning
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  hybridLabelhybrid Labellabel in printed and digital format
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  printedLabelprinted Labellabel in printed format
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  secondaryLabel2nd Labelany other label provided for medicinal product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  documentdocumentany kind of a document
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  shippingDocumentshipping documentdocument that is shipped with the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingListpackaging listlist of items packaged with the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  technicalDescriptiontechnical descriptiondescription with technical details
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  installationManualinstallation manualmanual describing the installation of the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  quickReferenceGuidequick reference guide
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  protocolprotocolprotocol of electronic interface
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  disposeInformationdispose informationinformation for disposing a medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  passportpassportany kind of passport, that collects or accomponies information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  implantCardimplant cardinformation about an implanted medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  digitalImplantCarddigital implant cardinformation about an implanted medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  batteryPassportbattery passport
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  specificationspecificationspecification
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  standardstandardstandard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso639ISO 639ISO 639: language codes
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso3166ISO 3166ISO 3166: country codes
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso3864ISO 3864ISO 3864: colours for safety signs
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso7000ISO 7000ISO 7000: Graphical Symbols for use on Equipment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso7010ISO 7010ISO 7010: Safety colours and safety signs
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso14617ISO 14617ISO 14617: Graphical symbols for diagrams
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso14971ISO 14971ISO 14971: Medical Devices - Application of Risk Management
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso15223ISO 15223ISO 15223: Medical devices - Symbols to be used with information to be supplied by the manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso20417ISO 20417ISO 20417:2026
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iec60417IEC 60417IEC 60417: Medical devices - Graphical Symbols for use on Equipment (database)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iso80000ISO 80000ISO 80000: Quantity and Units
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iec60878IEC/TR 60878IEC/TR 60878
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  implementationGuideIGimplementation guide
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productSpecificationproduct specification
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  edocumentatione-documentationform of electronically accessible information supplied by the manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  purposepurposepurpose of use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  pictogrampictogramgraphical representation of something
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  iconiconsymbol or icon
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  informationinformationany kind of information about the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  addtlInfoadditional information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  accompanyingInfoaccompanying informationinformation supplied by the manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  generalInfogeneral information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingInfopackaging information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  safetyInfosafety information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  markingInfomarkinginformation, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to a product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturerInformationmanufacturer informationinformation provided by manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  instructioninstructionany kind of instruction for someone
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  specialOperatingInstructionspecial operating instruction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  instructionForUseinstruction for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  requirementrequirement
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electronicInstructionelectronic instruction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  riskriskrisk when using the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  generalRiskgeneral risk
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  residualRiskresidual riskremaining risk after mitigation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  hazardhazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  microbialHazardmicrobial hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  infectioninfection
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  environmentalHazardenvironmental hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  radiationHazardradiation hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  allergicReactionHazardallergic reaction hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  physicalHazardphysical hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  carcinogenicHazardcarcinogenic
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  mutagenicHazardmutagenic
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  toxicHazardtoxic
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  toxicToReproductionHazardtoxic to reproduction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  endocrineDisruptingHazardendcorine disrupting
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  riskControlMeasurerisk control measure
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  intendedUseintended usedescription of the intended use (normally in combination with any risk)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  criticalCharacteristiccritical characteristics
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  environmentenvironment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  interfaceinterface
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electronicInterfaceelectronic interface
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  policypolicy
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  applicablePolicyapplicable policy
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  authorityauthorityany kind of an authority; could be an organisation or person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  authorityHavingJurisdictionauthority having jurisdictiongovernmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  rolerolerole that someone plays
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  roleUseruser (role)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  roleLayUserlay user (role)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  rolePatientpatient (role)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  roleManufracturermanufacturer (role)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  roleProducerproducer (role)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  jurisdictionjurisdiction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  lotlotdefined amount of material or a defined number of medical devices, including finished product and accessories, that is manufactured in one process or a series of related processes and is intended to be homogenous
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  softwaresoftwaresoftware used in conjunction with the medical device

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code