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

Official URL: http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement Version: 0.4.15
Active as of 2026-10-07 Computable Name: DigitalLabelElementVS
Other Identifiers: OID:1.2.3.4.5.6.7.8.10.10

Copyright/Legal: FO

all concept/items from Digital Label Element

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 498 concepts

SystemCodeDisplay (en)InactiveDefinitionstatusDigital Label Element ConceptMap OntologyDigLblElement -> ISO 7010DigLblElement -> ISO 7000JSONXML
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?productCode(0..1)
?catalogNumber(0..1)
?distributor(1..*)
?lotNumber
?serialNumber
?dateSafeForUse
?productionDate
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)?accessory
?accompanyingInfo(0..*)
?label
?lot
?catalogNumber
?udi
?catalogNumber(1)
?modelNumber(1)
?sterile
?methodOfSterilization
?sterileBarrierConfiguration
?modelNumber
?catalogNumber
?size
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?consumableComponent
?medicalDevice
?sparePart
?catalogNumber
?catalogNumber
?udi
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?responsible
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturermanufacturerorganisation that produces the product?information(0..*)
?catalogNumber
?edocumentation
?unit
?symbol
?language
?symbolIso7000-3082
?symbolIso15223-5.1.1
?authorizedRepresentative
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  distributordistributorwho distributes the product??organization(1)
?manufacturer
?importer
?manufacturer
?importer
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?organization
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?jurisdictionalPerson
?symbolToIdentify
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  animalAnimalanimal
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  labelLabellabel for medicinal product?packagingInfo
?markingInfo
?accessory
?informationForm
?manufacturer
?medicalDevice
?accessory
?instructionForUse
?symbolIso7010
?humanReadable
?machineReadable
?markingInfo
?name(1..*)
?tradeName
?address(1..*)
?manufacturer(1)
?authorizedRepresentative
?country
?medicalDevice
?accessory
?transportCondition
?storageCondition
?handlingCondition
?specialOperatingInstruction
?warning
?precaution
?symbolIso7000-2725
?symbolIso15223-5.4.10
?symbolEn15986-xxx
?symbolIso7000-3723
?electronicInstruction
?symbolIso15223-5.4.3
?symbolIso7000-1641
?noReuse
?singleUse
?symbolIso7000-1051
?symbolIso15223-5.4.2
?singlePatientMultipleUse
?symbolIso7000-3706
?symbolIso15223-5.4.12
?limitation
?sterile
?methodOfSterilization
?symbolIso7000-2500
?symbolIso15223-5.2.2
?symbolIso7000-2501
?symbolIso15223-5.2.3
?symbolIso7000-2502
?symbolIso15223-5.2.4
?symbolIso7000-2503
?symbolIso15223-5.2.5
?productionControlIdentifier
?dateSafeForUse
?symbolIec60417
?symbolIso7000
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?installing
?preparing
?maintaining
?repairing
?transport
?instructionForUse
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?iso3166
?iso7000
?iso7010
?iso14971
?iso15223
?iec60417
?iso80000
?iso14971
?accessory
?accompanyingInfo(1)
?applicablePolicy
?havingJurisdiction
?authorizedRepresentative
?catalogNumber
?productName
?productCode
?distributor
?edocumentation
?expectedLifeTime
?standard
?importer
?safetyInfo
?manufacturerInformation
?manufacturerInformation
?instructionForUse
?label
?label
?layUser
?lot
?lotNumber
?markingInfo
?medicalDevice
?deviceFamily
?modelNumber
?multiplePatientMultipleUse
?normalUse
?organization
?patient
?subjectOfCare
?pictogram
?procedure
?symbolIso7010
?serialNumber
?servicePersonnel
?shelfLife
?shelfLife
?singlePatientMultipleUse
?singlePatientMultipleUse
?singleUse
?singleUse
?stability
?stability
?sterile
?sterile
?symbol
?symbol
?technicalDescription
?technicalDescription
?udi
?udi
?usability
?usability
?environment
?environment
?useSpecification
?useSpecification
?userType
?riskManagement
?addtlInfo
?country
?date
?address
?modelNumber
?modelNumber
?catalogNumber
?identifier
?multipleUse
?sterile
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?manufacturerInformation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  purposepurposepurpose of use?diagnostics
?prevention
?monitoring
?alleviationOfDisease
?investigation
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?safetyInfo
?printed
?symbol
?justification
?condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  addtlInfoadditional information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  accompanyingInfoaccompanying informationinformation supplied by the manufacturer?label(0..1)
?markingInfo(0..1)
?instructionForUse(0..1)
?technicalDescription(0..1)
?information(0..1)
?installationManual(0..1)
?quickReferenceGuide(0..1)
?installing(0..1)
?electronic
?cdrom
?dvd
?usb
?website
?skill
?training
?knowledge
?instructionForUse
?technicalDescription
?medicalDevice
?manufacturer
?deviceFamily
?modelNumber
?catalogNumber
?description
?layUser
?edocumentation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  generalInfogeneral information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingInfopackaging information?tradeName
?address
?authorizedRepresentative
?noReuse
?singleUse
?symbolIso7000
?singlePatientMultipleUse
?intendedUse
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  safetyInfosafety information?riskManagement
?warning
?error
?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?format
?risk
?jurisdiction
?legible
?durableThruLifetime
?durableThruShelfLife
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturerInformationmanufacturer informationinformation provided by manufacturer?edocumentation
?shippingDocument
?packagingList
?medicalDevice
?safetyInfo
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?safetyInfo
?roleUser
?safetyInfo
?specialOperatingInstruction
?warning
?accompanyingInfo
?intendedUse
?safetyInfo
?residualRisk
?contraIndication
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?limitation
?contraIndication
?precaution
?warning
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?humanBehavior
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  environmentenvironment?condition
?condition
?useEnvironment
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?requirement
?format
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  authorityauthorityany kind of an authority; could be an organisation or person?applicablePolicy
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?countryOfOrigin
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?condition
?manufacturing
?date
?lotNumber
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  softwaresoftwaresoftware used in conjunction with the medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dataElementdata elementinactiveany kind of data element being used (as part of the objects being modelled)inactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  identifieridentifierany kind of identifier?uniqueNumber
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  catalogNumbercatalog numbernumber in a catalog?manufacturing
?alphanumericFormat
?productCode(0..*)
?specification
?stringFormat
?symbol
?symbolIso7000-2493
?symbolIso15223-5.1.6
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productIdentifierproduct identifierproduct identifier
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productionControlIdentifierproduction control identifierproduction control identifier?serialNumber
?serialNumber
?donorIdentifier
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productCodeproduct code
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  lotNumberlot numberlot number?stringFormat
?symbol
?stringFormat
?symbolIso7000
?symbolIso15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  batchNumberbatch numberbatch number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  modelNumbermodel numbermodel number?catalogNumber
?catalogNumber(0..*)
?singleUse
?singlePatientMultipleUse
?multiplePatientMultipleUse
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  labelModelNumbermodel number on labelmodel number on a label?stringFormat
?symbolIec60417-6050
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  serialNumberserial numberserial number?uniqueNumber
?stringFormat
?symbol
?stringFormat
?symbolIso7000
?symbolIso15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  versionIdentifierversion identifierversion identifier
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  donorIdentifierdonor identifieridentifier for the donor
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  udiUDIunique device identifier?barcode
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolToIdentifysymbol to identify on a labelwhat is the symbol used on a label to identify this product??iso7000
?iso7010
?iso15223
?iec60417
?iec60878
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  urlurlURL or webaddress
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  conformityAssessmentOrgIDID of organisation performing the conformity assessment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  namenamename of something, eg. person, organisation, product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  personNameperson namename of a person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  givenNamegiven namegiven or first name of a person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  familyNamefamily namefamily name of a person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  organizationNameorganization namename of an organization
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productNamename of the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  tradeNametrade nametrade name for the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  tradeMarktrade marktrade mark for the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  assemblerNamename of assemblername of person that assembles the device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  addressaddressaddress and parts thereof?street
?number
?city
?state
?region
?postalCode
?country
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  streetstreetstreet name
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  numbernumbernumber/house/floor
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  citycitycity
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  statestate(federal) state
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  regionregionregion (by name)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  postalCodepostal codepostal or ZIP code
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  countrycountrycountry as string or code (ISO 3166)?countryCode
?code
?stringFormat
?string
?code
?countryCode
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  countryOfOrigincountry of origin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturerAddressmanufacturer addressaddress of manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  registeredPlaceOfBusinessregistered place of businesswhat is the manufacturer registered address
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  titletitletitle
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  descriptiondescriptiona long description
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  expectedLifeTimeexpected lifetimeperiod specified by the manufacturer during which the product is expected to remain safe and effective for use?expectedServiceTime
?maintaining
?repairing
?absoluteExpectedLifeTime
?relativeExpectedLifeTime
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  absoluteExpectedLifeTimeabsoluteabsolute expected lifetime
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  relativeExpectedLifeTimerelativerelative expected lifetime
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  expectedServiceTimeexpected service Timeexpected time this product is in service
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usageCountusage count
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usageCountByCycleusage count by cycle (repetitions)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usageCountByTimeusage count by time (period of time^)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateany date?dateYYYYMMDD
?dateYYYYMM
?dateYYYY
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  productionDateproduction date?symbolIso7000
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturingDateproduction date
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateSafeForUsedate until safe for use?symbolIso7000
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  revisionDaterevision date
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sizesizesize
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  physicalSizephysical sizephysical size of the medical device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  heightheightheight
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  widthwidthwidth
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  depthdepthdepth
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingSizepackaging sizepackaging size of the medical device in form of contained items
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  markingmarkingmarking
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  markCECE markmark with CE symbol
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  statementstatementany kind of a statement
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  justificationjustificationjustification for (the omission) of an activity
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  compatibilityStatementcompatibility statementstatement of compatibility
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  conformityDeclarationEUEU conformity declaration
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  contactInformationcontactcontact information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  telephoneNumbertelephonetelephone number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  mobilePhonemobilemobile phone number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  emailemailemail address
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  faxfaxtelefax
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  websitewebsite(url of) website
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  languagelanguage?applicablePolicy
?code
?stringFormat
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  educationalLeveleducational level
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  timeOfSynchronisationtime of synchronisation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  summaryOfTestingsummary of testing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  connectionSettingconnection setting
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sterileBarrierConfigurationsterile barrier configuration
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  unitunitsunits of measurement, eg. SI or UCUM?unitSI
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  unitSISI unitsSI
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  unitUCUMUCUM unitsUnified Codes for Units of Measurement (UCUM)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  shelfLifeshelf-lifeperiod during which a product maintains its stability
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dataTypedata typeinactivedata types helping to specify details of data elementsinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  DTidentifieridentifier (DT)identifier (as datatype)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  stringstringany character sequence
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  DTdatedatea date of any precision (YYYY,MM, DD)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  timetimetime (clock)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateTimetimea point in time
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  codecodecoded information (code + codesystem + codesystemversion)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  quantityquantityphysical quantity (value + unit)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  lengthlentghlength (value + unit)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  volumevolumevolume (value + unit)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  portionportion
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  formatformatinactiveformat of certain datainactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateTimeFormatdate/time formats
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateYYYYformat as YYYY
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateYYYYMMformat as YYYY-MM
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dateYYYYMMDDformat as YYYY-MM-DD
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  timeFormattime formats
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  stringFormatstring formatsany sequence of characters
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  numericFormatnumeric formatany sequence of numbers
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  alphanumericFormatalphanumeric formatany sequence of printable characters
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  procedureprocedureinactiveprocedure to perform when handling the productinactive?preparing
?sterilizing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  documentingdocumenting
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  labelinglabelingcreating and attaching a label
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  relabelingrelabelingattaching a new label (different from the original)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  formattingformatting data
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  storingstoring
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  storingAfterUsestoring after use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  preparingpreparing for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  assemblingassembling for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  calibratingcalibrating for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  manufacturingmanufacturingmanufacturing of the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  testingtesting
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  repairingrepairing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingpacking
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  repackagingre-packaging
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  qualityControlquality control
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  riskManagementmanaging risks?riskControlMeasure
?hazard
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  registeringregisteringregistration of the MD in an official registry, eg the EUDAMED UDI and device registration module
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  transporttransporttransporting the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  importingimporting
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  distributingdistributing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  installinginstallinginstalling the product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sterilizingsterilizing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  maintainingmaintaining
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usingusing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  reprocessingreprocessingpreparing for a second use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  refurbishingrefurbishingpreparing for a second use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  trainingtraining
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  disposingdisposing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  measuringmeasuringthe device has a measuring function
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  propertyspecial property valuesinactivelist of properties that can be assigned to the medical device or attributesinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  uniqueNumberthe number or identifier is unique
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sterilesterile
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  nonSterilenon-sterile
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sealedsealed
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  clinicalInvestigationOnlyfor clinical investigation only
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  inVitroDiagnosticsUsefor in-vitro diagnostics use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  calibratedcalibrated
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  detachabledetachabledetachable or removable
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  consumableconsumable
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  legiblelegible
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  packagingLayerpackaging layer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  accuracyaccuracy
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  frequencyOfResponsefrequency of response
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  reprocessingLimitmax number of reprocessing the device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  latencylatency
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  bandwidthbandwidth
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dataRatedata rate
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  timeSynchronizationtime synchronization
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  colorcolorcolor (code)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  strengthstrength
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  commercialProductcommercial product
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  registeredregistered
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  textspecial textsinactivespecial textual strings or wordings to be usedinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  txtLotNumberLOT NUMBER
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  txtSerialNumberSERIAL NUMBER
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  txtExclusively4ClinicalUseexclusively for clinical use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  txtExclusively4ClinicalInvestigationexclusively for clinical investigation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  codesystemspecial codes/valuesinactiveprobably codes or values to select from; they must be separated into distinct code systemsinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  hinthint on error/warning
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  errorerror
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  warningwarning
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  precautionpre-caution
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  contraIndicationcontraindication
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  purposeTypetype of purpose
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  diagnosticsdiagnostics
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  monitoringmonitoring
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  preventionprevention
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  treatmenttreatment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  alleviationOfDiseasealleviation of disease
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  compensationForInjurycompensation for injury
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  replacementreplacement
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  modificationmodification
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  desinfectiondesinfection
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  investigationinvestigation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  providingInVitroDataprovidingInVitroData
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  controlConceptioncontrolConception
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  supportingLifesupporting of sustaining life
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  supportingAnatomysupporting the anatomy
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  supportingPhysiologicalProcesssupporting a physiological process
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceFamilydevice family
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClassclass of device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClass1class 1low risk
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClass2class 2
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClass2aclass 2alow-to-medium risk
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClass2bclass 2bmedium-to-high risk
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceClass3class 3high risk
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  deviceTypetype of device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  implantimplant
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  ivdIVDin-vitro device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  edocumentationCarriercarrier of e-documentation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  cdromCD-ROM
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  dvdDVD
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usbusb device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  websiteCarrierwebsite (as carrier of information)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multipleUsepossible multiple use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multiplePatientMultipleUsemultiple patient, multiple use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  singlePatientMultipleUsesingle patient, multiple use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  singlePatientSingleUsesingle patient, single use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  singleUsesingle use?noReuse
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  noReuseno re-use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  normalUsenormal use?maintaining
?transport
?error
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  standBystand-by
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  routineroutine
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  inspectioninspection
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  useEnvironmentuse environment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  useAtHomeat home
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  useInClinicin clinic
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  useSpecificationuse specification?environment
?intendedUse
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  subjectOfCaresubject of caresubject of care, normally the patient itself?person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  subjectPersonperson (as subject)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  patientpatient?educationalLevel
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  subjectAnimalanimal (as subject)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sizeLimitsize limit
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  smallSizesmall sizethe item is (too) small in its size
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  normalSizenormal sizethe item has normal size for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  largeSizelarge sizethe item is relatively big in its size
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  timingtiming
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  absoluteTimingabsolute timing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  relativeTimingabsolute timing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  maxCycleTimingtiming maximum cycles
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humanBehaviorhuman behavior
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  limitationlimitation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  abilityability
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  skillskill
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  knowledgeknowledge
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  educationeducation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  conditionconditioncondition(s) under which the medical devices can be operated
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  transportConditiontransport condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  handlingConditionhandling condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  storageConditionstorage condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  environmentConditionenvironmental condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  hygienicConditionhygienic condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  frequencyOfUseConditionfrequency of use condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  locationConditionlocation condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  cleanRoomConditionclean room condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  magneticFieldConditionmagnetic field condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  lightningConditionlightning condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  radiationConditionradiation condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electricConditionelectric condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electricDischargeConditionelectric discharge condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  noiseConditionnoise condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  pressureConditionpressure condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  temperatureConditiontemperature condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humidityConditionhumidity condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  sterileConditionsterile condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  mobilityConditionmobility condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  degreeOfInternantionalizationConditiondegree of internationalization condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  exclusiveConditionexclusive conditionrestrictions on combinations with other devices or equipment
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  socialConditionsocial condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  teamConditionteam condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  individudalConditionindividual condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  chaoticConditionchaotic condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  calmConditioncalm condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  stressLevelConditionstress level condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  stressLengthConditionstress length condition
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  stabilitystability of the product?expectedLifeTime
?medicalDevice
?sterile
?transport
?storing
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  countryCodecountry codeISO 3166 country codes
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  languageCodelanguage codeISO 639 language codes
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  methodOfSterilizationmethod of sterilization
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  methodOfRiskEliminationmethod of risk elimination
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  methodOfRadiationProtectionprotective measure against radiation
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  originorigin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  biologicalOriginbiological origin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humanOriginhuman origin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  animalOriginanimal origin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  containmentcontains ...
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  containsMedicalSubstancecontains medical substance
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  containsNanoParticlecontains nano particles
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  containsHazardousSubstancecontains hazardous substance
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multipleLanguagesnecessity of multiple languages
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multipleLanguageNeededmultiple language needed
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multipleLanguageNotNeededmultiple language not needed
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolsymbols?symbolIso7010
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolOnPackagesymbols on package
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000iso 7000 symbols
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-10511051symbol ISO 7000: 1051 (do not re-use)~1051
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-16411641symbol ISO 7000: 1641~1641
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-24922492symbol ISO 7000: 2492~2492
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-24932493symbol ISO 7000: 2493~2493
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-24972497symbol ISO 7000: 2497~2497
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-24992499symbol ISO 7000: 2499~2499
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-25002500symbol ISO 7000: 2500~2500
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-25012501symbol ISO 7000: 2501~2501
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-25022502symbol ISO 7000: 2502
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-25032503symbol ISO 7000: 2503~2503
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-26072607symbol ISO 7000: 2607~2607
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-27252725symbol ISO 7000: 2725 (hazardous substance, eg latex)~2725
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-30823082symbol ISO 7000: 3082~3082
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-36993699symbol ISO 7000: 3699~3699
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37003700symbol ISO 7000: 3700~3700
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37013701symbol ISO 7000: 3701~3701
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37023702symbol ISO 7000: 3702~3702
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37033703symbol ISO 7000: 3703~3703
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37063706symbol ISO 7000: 3706 (single patient multiple use)~3706
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-37233723symbol ISO 7000: 3723 (endocrine disrupting, carcinogenic, mutagenic or toxic ror reproduction substances)~3723
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7000-60416041symbol ISO 7000: 6041 (instructions for use)~6041
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7010iso 7010 safety signs
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7010-M001M001safety sign ISO 7010: M001~M001
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7010-M002M002safety sign ISO 7010: M002~M002
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7010-P001P001safety sign ISO 7010: P001~P001
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso7010-W001W001safety sign ISO 7010: W001~W001
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223iso 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.15.1.1: manufacturersymbol 5.1.1 from ISO 15223: manufacturer
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.35.1.3: date of manufacturesymbol 5.1.3 from ISO 15223: date of manufacture
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.45.1.4: date safe to usesymbol 5.1.4 from ISO 15223: date safe to use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.55.1.5: lot numbersymbol 5.1.5 from ISO 15223: lot number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.65.1.6: catalog numbersymbol 5.1.6 from ISO 15223: catalog number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.75.1.7: serial numbersymbol 5.1.7 from ISO 15223: serial number
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.1.125.1.12: authorized representativesymbol 5.1.12 from ISO 15223: authorized representative
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.15.2.1symbol 5.2.1 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.25.2.2symbol 5.2.2 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.35.2.3symbol 5.2.3 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.45.2.4symbol 5.2.4 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.55.2.5symbol 5.2.5 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.2.105.2.10symbol 5.2.10 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.25.4.2: do not re-usesymbol 5.4.2 from ISO 15223: do not re-use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.35.4.3: instructions for usesymbol 5.4.3 from ISO 15223: instructions for use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.55.4.5: latexsymbol 5.4.5 from ISO 15223: latex
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.65.4.6symbol 5.4.6 from ISO 15223: contains human blood or plasma derivatives
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.75.4.7symbol 5.4.7 from ISO 15223: contains medicinal substances
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.85.4.8symbol 5.4.8 from ISO 15223: contains biological material of animal origin
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.95.4.9symbol 5.4.9 from ISO 15223
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.105.4.10symbol 5.4.10 from ISO 15223: endocrine disrupting, carcinogenic, mutagenic or toxic to reproduction substances
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.115.4.11symbol 5.4.11 from ISO 15223: contains nanotech materials
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.4.125.4.12symbol 5.4.12 from ISO 15223: single patient multiple use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIso15223-5.7.105.7.10symbol 5.7.10 from ISO 15223: UDI carrier
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIec60417iec 60417
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolIec60417-60506050symbol 6050 from IEC 60417
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolEn15986en 15986
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  symbolEn15986-xxxxxxsymbol ???? from EN 15986 (phthalates)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  instructionCommandinstructon (command)instructions to be used as a command
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  doNotUsedo not use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  doNotReusedo not re-use
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  doNotOpendo not open
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  doNotDropdo not drop
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  wearGlovewear glove
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  keepAwayFromkeep away from ...
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  scrubBeforeEnteringscrub before entering
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  userTypetype of user?layUser
?professional
?patient
?person(0..*)
?healthProfessional
?servicePersonnel
?patient
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  professionalprofessional
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  healthProfessionalhealth professionalany health professional
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  physicianphysician
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  assistant(medical/technical) assistant
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  servicePersonnelservice personnel
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  informedPatientinformed patient
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  caregivercaregiver
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  layUserlay user
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  processorprocessor
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  maintenanceTypetype of maintenance
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  regularregular maintenance
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  preventivepreventive maintenance
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  poweringpowering of device
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  batteryPoweredpowered by batteries
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  powerGridattached to normal power grid
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  durabilityOfMarkingdurability of markings
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  waterResistantwater resistant
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  uvResistantUV resistant
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  durableThruLifetimedurable through normal/declared lifetime
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  durableThruShelfLifedurable through shelf-life
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  usabilityusability
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  efficiencyefficency
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  satisfactionsatisfaction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  readabilityreadability of label?person
?person
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humanReadablenormal readability by humans
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  machineReadablereadability by a machine
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  braillebrailleraadable by blind
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  authorityLevellevel of authorization
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  responsibleresponsible
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  havingJurisdictionauthority having jurisdiction
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  informationFormform of information
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  auditoryauditory
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  electronicelectronic
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  rfidrfid
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  multimediamulti-media
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  printedprintedprinted/written
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  barcodebarcodebarcode
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  qrcodeQR codeQR code
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  linearbarcodelinear barcodelinear barcode
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  matrixcodematrix barcodematrix barcode
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  tactiletactile
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  actoractor conceptsinactivewhat are the actors involved with digital labelsinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  precoordinatedConceptpre-coordinated conceptsinactivefollowing a list of items that are a precoordination of other concepts in order to simplify the collection and indication of requirementsinactive
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humanBloodhuman blood
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  plasmaDerivativeplasma derivative
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  tissuetissue
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  humanCellhuman cell
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  animalCellanimal cell
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  AIsystemAI system
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement  generativeAIsystemgenerative AI system

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