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

CodeSystem: Digital Label Element Property Ontology (Experimental)

Official URL: http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelOntology2 Version: 0.4.15
Active as of 2026-10-21 Computable Name: DigitalLabelOntology2CS

Ontology that supplements the Digital Label Elements (based on Supplement)

This Code system is referenced in the content logical definition of the following value sets:

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

Properties

This code system defines the following properties for its concepts

NameCodeURITypeDescriptionValue Set
has component hasComponent http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasComponent code what is the associated component to this element? This helps to create the information model. Digital Label Element
mentions mentions http://www.hl7europe.org/medtechlabel/CodeSystem/Property#mentions code Where is this information item mentioned? Digital Label Element
defines defines http://www.hl7europe.org/medtechlabel/CodeSystem/Property#defines code What does this information item define? Digital Label Element
identified by identifiedBy http://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifiedBy code How is this element identified? Digital Label Element
related to relatedTo http://www.hl7europe.org/medtechlabel/CodeSystem/Property#relatedTo code to which element is this item related? This helps to create the information model. Digital Label Element
partOf partOf http://hl7.org/fhir/concept-properties#partOf code part of Digital Label Element
has value hasValue http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasValue code what is the specific value to use? This helps to create the information model. Digital Label Element
has format hasFormat http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasFormat code what is the specific value to use? This helps to create the information model. Digital Label Element
has datatype hasDataType http://www.hl7europe.org/medtechlabel/CodeSystem/Property#hasDataType code what is the specific value to use? This helps to create the information model. Digital Label Element
implies implies http://www.hl7europe.org/medtechlabel/CodeSystem/Property#implies code what other element is implied by this one? Digital Label Element
applies to appliesTo http://www.hl7europe.org/medtechlabel/CodeSystem/Property#appliesTo code which other element does this one apply to? Digital Label Element
equivalent to equivalentTo http://www.hl7europe.org/medtechlabel/CodeSystem/Property#equivalentTo code which other element is this one equivalent to? Digital Label Element
identifies identifies http://www.hl7europe.org/medtechlabel/CodeSystem/Property#identifies code which other element does this one identify? Digital Label Element
is-a is-a http://www.hl7europe.org/medtechlabel/CodeSystem/Property#is-a code what is another parent element? Digital Label Element

Concepts

This code system supplement http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelOntology2 defines properties on the following codes:

LvlCodeDisplayDefinitionhas componentmentionsdefinesidentified byrelated topartOfhas valuehas formathas datatypeimpliesapplies toequivalent toidentifiesis-a
1 organization organisation any kind of an organization being involved organizationName, address, contactInformation responsible
1 person Person person personName, address, contactInformation
1 label Label label for medicinal product title, description, icon, barcode, packagingInfo, symbolIso7010, name, tradeName, address, manufacturer, authorizedRepresentative, country, transportCondition, storageCondition, handlingCondition, specialOperatingInstruction, warning, precaution, limitation, methodOfSterilization, productionControlIdentifier, dateSafeForUse, symbolIec60417, symbolIso7000 electronicInstruction, sterile symbolIso7000-2725, symbolIso15223-5.4.10, symbolEn15986-xxx, symbolIso7000-3723, symbolIso15223-5.4.3, symbolIso7000-1641, noReuse, singleUse, symbolIso7000-1051, symbolIso15223-5.4.2, singlePatientMultipleUse, symbolIso7000-3706, symbolIso15223-5.4.12, symbolIso7000-2500, symbolIso15223-5.2.2, symbolIso7000-2501, symbolIso15223-5.2.3, symbolIso7000-2502, symbolIso15223-5.2.4, symbolIso7000-2503, symbolIso15223-5.2.5 informationForm markingInfo, accessory manufacturer, medicalDevice, accessory, instructionForUse, medicalDevice, accessory
2   digitalLabel digital Label label in electronic format identifier
3     printedLabel printed Label label in printed format package, medicalDevice
1 organizationName organization name name of an organization string
2   personName person name name of a person givenName, familyName
2   tradeName trade name trade name for the product registered
2   tradeMark trade mark trade mark for the product registered
1 criticalCharacteristic critical characteristics humanBehavior usability, efficiency, satisfaction
1 fax string
2   versionIdentifier version identifier version identifier software, medicalDevice
1 txtLotNumber LOT NUMBER label
1 txtSerialNumber SERIAL NUMBER label
2   manufacturerAddress manufacturer address address of manufacturer manufacturer
2   electronicInstruction electronic instruction electronic
2   electronicInterface electronic interface electronic
2   countryOfOrigin country of origin manufacturer
2   authorityHavingJurisdiction authority having jurisdiction governmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory jurisdiction
1 registeredPlaceOfBusiness registered place of business what is the manufacturer registered address registered manufacturer
1 conformityAssessmentOrgID ID of organisation performing the conformity assessment conformityAssessmentOrg, markCE
2   assemblerName name of assembler name of person that assembles the device assembling
2   humanBlood human blood humanOrigin
2   plasmaDerivative plasma derivative humanOrigin
2   tissue tissue humanOrigin
2   humanCell human cell humanOrigin
2   animalCell animal cell humanOrigin
2   eudamed EUDAMED organization
1 standard standard iso3166, iso7000, iso7010, iso14971, iso15223, iec60417, iso80000, iso14971, accessory, accompanyingInfo, applicablePolicy, havingJurisdiction, authorizedRepresentative, catalogNumber, productName, productCode, distributor, edocumentation, expectedLifeTime, importer, safetyInfo, manufacturerInformation, instructionForUse, label, layUser, lot, lotNumber, markingInfo, medicalDevice, deviceFamily, modelNumber, multiplePatientMultipleUse, normalUse, organization, patient, subjectOfCare, pictogram, procedure, symbolIso7010, serialNumber, servicePersonnel, shelfLife, singlePatientMultipleUse, singleUse, stability, sterile, symbol, technicalDescription, udi, usability, usability, environment, useSpecification, userType, country, date, address, modelNumber, catalogNumber, identifier, multipleUse, sterile manufacturerInformation, label, shelfLife, singlePatientMultipleUse, singleUse, stability, sterile, symbol, technicalDescription, udi, environment, useSpecification, modelNumber riskManagement, addtlInfo
1 medicalDevice accessory, accompanyingInfo, label, size catalogNumber, udi, catalogNumber, modelNumber, sterile, methodOfSterilization, sterileBarrierConfiguration, modelNumber, catalogNumber lot
1 accessory catalogNumber udi consumableComponent, medicalDevice, sparePart
1 manufacturer language symbolIso15223-5.1.1, authorizedRepresentative edocumentation
1 accompanyingInfo label, marking, instructionForUse, technicalDescription, information, installationManual, quickReferenceGuide, installing, instructionForUse, technicalDescription, modelNumber, catalogNumber, description, edocumentation electronic, cdrom, dvd, usb, website skill, training, knowledge medicalDevice, manufacturer, deviceFamily
1 edocumentation manufacturerInformation
1 applicablePolicy requirement, format
1 authority applicablePolicy
1 authorizedRepresentative symbolToIdentify
1 catalogNumber symbol symbolIso7000-2493, symbolIso15223-5.1.6 productCode, stringFormat specification manufacturing
1 product productCode, catalogNumber, lotNumber, serialNumber, dateSafeForUse, productionDate distributor
1 readability person, person
1 distributor importer, manufacturer, importer
1 stability medicalDevice, sterile, transport, storing
1 expectedLifeTime absoluteExpectedLifeTime, relativeExpectedLifeTime maintaining, repairing expectedServiceTime
1 importer organization
1 riskManagement riskControlMeasure, hazard
1 safetyInfo warning, error, information riskManagement
1 instructionForUse specialOperatingInstruction, warning, accompanyingInfo, intendedUse, safetyInfo, residualRisk, contraIndication roleUser, safetyInfo safetyInfo
1 information safetyInfo, condition printed, symbol justification
1 manufacturerInformation edocumentation, shippingDocument, packagingList medicalDevice, safetyInfo
1 userType layUser, professional, person, healthProfessional, servicePersonnel, patient patient
1 lot lotNumber condition, manufacturing, date
1 markingInfo legible format risk durableThruLifetime, durableThruShelfLife
1 purpose diagnostics, prevention, monitoring, alleviationOfDisease, investigation
1 normalUse maintaining, transport, error
1 subjectOfCare person
1 procedure preparing, sterilizing
1 symbol symbolIso7010
1 serialNumber symbolIso15223 symbolIso7000 stringFormat, symbol, stringFormat uniqueNumber
1 singleUse noReuse
1 technicalDescription installing, preparing, maintaining, repairing, transport, instructionForUse
1 udi barcode
1 environment condition condition, useEnvironment
1 useSpecification environment intendedUse
1 unit unitSI
1 symbolToIdentify iso7000, iso7010, iso15223, iec60417, iec60878
1 language code, stringFormat
1 country countryCode, countryCode code, stringFormat, string, code
1 date dateYYYYMMDD, dateYYYYMM, dateYYYY
1 address street, number, city, state, region, postalCode, country
1 modelNumber catalogNumber catalogNumber, singleUse, singlePatientMultipleUse, multiplePatientMultipleUse
1 identifier uniqueNumber
1 jurisdiction countryOfOrigin
1 labelModelNumber symbolIec60417-6050 stringFormat
1 lotNumber symbolIso7000, symbolIso15223 stringFormat, symbol, stringFormat
1 productionControlIdentifier serialNumber, donorIdentifier serialNumber
1 dateSafeForUse symbolIso7000
1 productionDate symbolIso7000
1 packagingInfo authorizedRepresentative, intendedUse noReuse, singleUse, symbolIso7000, singlePatientMultipleUse tradeName, address
1 residualRisk limitation, contraIndication, precaution, warning