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 (Experimental)

Official URL: http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement Version: 0.4.15
Active as of 2026-10-21 Computable Name: DigitalLabelElementCS
Other Identifiers: OID:1.2.3.4.5.6.7.8.9.10

All possible digital label elements are listed in this codesystem in form of a taxonomy to help aligning it with. This list is also referred to as digital label element library.

The table below is technically administered as a codesystem. It allows for maintaining the relevant details in a computable fashion. The table contains all elements that are named either in legal requirements or standard documents. (The origin is mentioned in the appropriate column if deviating from ISO 20417, the default.)

As far as possible, each item/element is named as an atomic concept, i.e. it can be used and explained individually.

Some columns may need a more detailed explanation:

  • status: the colored rows are inactive or just for administrative/organisational purpose
  • Parent: normally, most elements are organized in a hierarchy so that the parent element is shown one level up immediately before the element in question. However, for the precoordinated concepts at the end this is not possible. Therefore, the parent element is directly named.
  • synonym: alternative names
  • comment: any additional remark on the item
  • DLE type: how must this element be handled?
    • abstract: helps to organize in a hierarchy (artificially introduced)
    • model: has to be considered within the information model
    • standard: comes from or references a standard
    • property: something that represents a property of a device and that would exceed the limits of an information model if modelled individually
    • procedure: refers to a concept the represent a procedure when dealing with medical devices
    • datatype of an element
    • format: how an element should be visualized
    • text: fix texts to be used
    • actor in a process
    • codesystem/code: (set of) values for certain elements
  • legal or standard: is this element from a standard or a jurisdictional requirement? (An empty cell is defaulted to ISO 20417.)
  • category: role of the data element
  • "Deutsch": translation into German language (more languages are possible)

Beyond that, the rows of the table are organized in form of a taxonomy establishing several axes:


The table is organized in the order of the green arrow. That should help to orient thru the long list of concepts.

During the course of the project, the table (= codesystem) will be enhanced into an ontology that also describes the relationships among the different entries by properties. This will be provided by a supplement to this codesystem.

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

Properties

This code system defines the following properties for its concepts

NameCodeURITypeDescriptionValue Set
status status http://hl7.org/fhir/concept-properties#status code Status
Parent parent http://hl7.org/fhir/concept-properties#parent code Who is the parent element of this concept? Multiple parents are possible.
synonym synonym http://hl7.org/fhir/concept-properties#synonym code code to a synonym of this concept
comment comment http://hl7.org/fhir/concept-properties#comment string Comment
Inactive inactive http://hl7.org/fhir/concept-properties#inactive boolean inactive
DLE type dleType http://www.hl7europe.org/medtechlabel/CodeSystem/Property#dleType code what is the type of this element? This helps to create the information model. Digital Label Element Type
legal or standard requirement http://www.hl7europe.org/medtechlabel/CodeSystem/Property#requirement code from where is this item taken? (Default ISO 20417) Digital Label Element
category roleCategory http://www.hl7europe.org/medtechlabel/CodeSystem/Property#roleCategory code from where is this item taken? (Default ISO 20417) http://www.hl7europe.org/medtechlabel/ValueSet/ElementRoleCategory

Concepts

This case-sensitive code system http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement defines the following codes in a Is-A hierarchy:

LvlCodeDisplayDefinitionParentsynonymcommentInactiveDLE typelegal or standardcategoryDeutsch (German, de)
1 object any kind of object basic information objects for our model; these must be represented in the information model as classes true
2   physicalObject physical Object an object that physically exists abstract physisch existierendes Objekt
3     product product model C
4       medicalDevice medical device instrument, 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) model med. Gerät
4       sparePart spart part spare part replacing whole or part of the original medical device model Ersatzteil
5         battery battery battery providing electrical power to a medical device is also a (detachable) component model Batterie
4       component component component of the medical device model Komponente
5         detachableComponent detachable component detachable component of the medical device model abtrennbare Komponente
4       accessory accessory model Zubehör
4       consumableComponent consumable component model
3     container container box containing the items model Container/Behälter
3     package package outer container declared as the complete product model Paket
2   organization organisation any kind of an organization being involved model Organisation
2   person Person person model Person
3     naturalPerson natural person natural person abstract natürliche Person
3     jurisdictionalPerson jurisdictional person jurisdictional person abstract juristische Person
2   animal Animal animal abstract Tier
2   label Label label for medicinal product model Label
3     electronicLabel electronic Label label in electronic format digitalLabel model elektr. Label
3     digitalLabel digital Label digital label, potentially misleading with its generic meaning digitales Label
3     printedLabel printed Label label in printed format model gedrucktes Label
3     secondaryLabel 2nd Label any other label provided for medicinal product abstract
2   document document any kind of a document model Dokument
3     shippingDocument shipping document document that is shipped with the product model
3     packagingList packaging list list of items packaged with the product model Packliste
3     technicalDescription technical description description with technical details model Technische Beschreibung
4       installationManual installation manual manual describing the installation of the product model Installationsbeschreibung
4       quickReferenceGuide quick reference guide model
4       protocol protocol protocol of electronic interface model
4       disposeInformation dispose information information for disposing a medical device model
3     passport passport any kind of passport, that collects or accomponies information abstract legal
4       implantCard implant card information about an implanted medical device model
5         digitalImplantCard digital implant card information about an implanted medical device model
4       batteryPassport battery passport model legal
3     specification specification specification abstract Spezifikation
4       standard standard standard abstract Standard
5         iso639 ISO 639 ISO 639: language codes standard
5         iso3166 ISO 3166 ISO 3166: country codes standard
5         iso3864 ISO 3864 ISO 3864: colours for safety signs standard
5         iso7000 ISO 7000 ISO 7000: Graphical Symbols for use on Equipment standard
5         iso7010 ISO 7010 ISO 7010: Safety colours and safety signs standard
5         iso14617 ISO 14617 ISO 14617: Graphical symbols for diagrams standard
5         iso14971 ISO 14971 ISO 14971: Medical Devices - Application of Risk Management standard
5         iso15223 ISO 15223 ISO 15223: Medical devices - Symbols to be used with information to be supplied by the manufacturer standard
5         iso20417 ISO 20417 ISO 20417:2026 standard
5         iec60417 IEC 60417 IEC 60417: Medical devices - Graphical Symbols for use on Equipment (database) standard
5         iso80000 ISO 80000 ISO 80000: Quantity and Units standard
5         iec60878 IEC/TR 60878 IEC/TR 60878 standard
4       implementationGuide IG implementation guide abstract
4       productSpecification product specification abstract
2   purpose purpose purpose of use model Zweck
2   pictogram pictogram graphical representation of something synonym Piktogramm
3     icon icon symbol or icon symbol Icon
2   information information any kind of information about the product model Information
3     addtlInfo additional information model
3     accompanyingInfo accompanying information information supplied by the manufacturer model
3     generalInfo general information model
3     packagingInfo packaging information model
3     safetyInfo safety information model
3     markingInfo marking information, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to a product model
2   instruction instruction any kind of instruction for someone model
3     specialOperatingInstruction special operating instruction model
3     instructionForUse instruction for use model
3     requirement requirement model
2   risk risk risk when using the product this branch is mentioned and belongs to the general development of MDs but is not further considered here abstract Risiko
3     generalRisk general risk abstract generelles Risiko
3     residualRisk residual risk remaining risk after mitigation abstract Verbleibendes Risiko
3     hazard hazard abstract Gefahr
4       microbialHazard microbial hazard
5         infection infection Infektion
4       environmentalHazard environmental hazard
4       radiationHazard radiation hazard
4       allergicReactionHazard allergic reaction hazard
4       physicalHazard physical hazard legal
4       carcinogenicHazard carcinogenic legal
4       mutagenicHazard mutagenic legal
4       toxicHazard toxic legal
5         toxicToReproductionHazard toxic to reproduction legal
4       endocrineDisruptingHazard endcorine disrupting legal
3     riskControlMeasure risk control measure Risiko-Kontrollmassnahme
2   intendedUse intended use description of the intended use (normally in combination with any risk) model
2   criticalCharacteristic critical characteristics belongs to properties? model
2   environment environment as object or just as element? Umgebung
2   interface interface Schnittstelle
2   policy policy Policy
3     applicablePolicy applicable policy anwendbare Policy
2   authority authority any kind of an authority; could be an organisation or person
2   role role role that someone plays belongs to actors branch? Rolle
3     roleUser user (role) Benutzer
4       roleLayUser lay user (role) Laie
3     rolePatient patient (role) Patient (Rolle)
3     roleManufracturer manufacturer (role) Hersteller (Rolle)
3     roleProducer producer (role)
2   jurisdiction jurisdiction abstract
2   lot lot defined 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 model
2   software software software used in conjunction with the medical device model
1 dataElement data element any kind of data element being used (as part of the objects being modelled) true abstract Datenelement
2   identifier identifier any kind of identifier model Identifikator
3     catalogNumber catalog number number in a catalog model Katalognummer
3     productIdentifier product identifier product identifier model Produkt-Identifikator
3     productionControlIdentifier production control identifier production control identifier model Produktions-Identifikator
3     productCode product code synonym for product identifier?
3     lotNumber lot number lot number batchNumber model
3     batchNumber batch number batch number
3     modelNumber model number model number model
3     serialNumber serial number serial number model
3     versionIdentifier version identifier version identifier model
3     donorIdentifier donor identifier identifier for the donor model
3     udi UDI unique device identifier model
3     symbolToIdentify symbol to identify on a label what is the symbol used on a label to identify this product?
3     url url URL or webaddress model
2   name name name of something, eg. person, organisation, product model
3     personName person name name of a person model
4       givenName given name given or first name of a person
4       familyName family name family name of a person
3     organizationName organization name name of an organization model
3     productName name of the product tradeName model
3     tradeName trade name trade name for the product model
3     tradeMark trade mark trade mark for the product model legal
2   address address address and parts thereof model Adresse
3     street street street name model
3     number number number/house/floor model
3     city city city model
3     state state (federal) state model
3     region region region (by name) model
3     postalCode postal code postal or ZIP code model
3     country country country as string or code (ISO 3166) model
2   title title title model
2   description description a long description model
2   expectedLifeTime expected lifetime period specified by the manufacturer during which the product is expected to remain safe and effective for use model
3     absoluteExpectedLifeTime absolute absolute expected lifetime model
3     relativeExpectedLifeTime relative relative expected lifetime model
2   expectedServiceTime expected service Time expected time this product is in service model
2   usageCount usage count model
3     usageCountByCycle usage count by cycle (repetitions) model
3     usageCountByTime usage count by time (period of time^) model
2   date any date abstract
3     productionDate production date manufacturingDate model
3     manufacturingDate production date model
3     dateSafeForUse date until safe for use model
3     revisionDate revision date model
2   size size size model
3     physicalSize physical size physical size of the medical device model
4       height height height
4       width width width
4       depth depth depth
3     packagingSize packaging size packaging size of the medical device in form of contained items model
2   marking marking marking model
3     markCE CE mark mark with CE symbol model legal CE-Zeichen
2   statement statement any kind of a statement model Aussage
3     justification justification justification for (the omission) of an activity model Begründung
3     compatibilityStatement compatibility statement statement of compatibility model legal
4       conformityDeclarationEU EU conformity declaration legal
2   contactInformation contact contact information model Kontaktinformation
3     telephoneNumber telephone telephone number model Telefonnummer
4       mobilePhone mobile mobile phone number model
3     email email email address model Email
3     fax fax telefax model Fax
3     website website (url of) website model Webseite
2   language language Sprache
2   educationalLevel educational level
2   timeOfSynchronisation time of synchronisation Zeitpunkt der Synchronisation
2   summaryOfTesting summary of testing
2   connectionSetting connection setting
2   sterileBarrierConfiguration sterile barrier configuration
2   unit units units of measurement, eg. SI or UCUM model Einheit
3     unitSI SI units SI handled via datatype abstract SI-Einheit
3     unitUCUM UCUM units Unified Codes for Units of Measurement (UCUM) handled via datatype abstract UCUM Einheit
2   shelfLife shelf-life period during which a product maintains its stability model
1 dataType data type data types helping to specify details of data elements true abstract
2   DTidentifier identifier (DT) identifier (as datatype) datatype
2   string string any character sequence datatype
2   DTdate date a date of any precision (YYYY,MM, DD) datatype
2   time time time (clock) datatype
2   dateTime time a point in time datatype
2   code code coded information (code + codesystem + codesystemversion) datatype
2   quantity quantity physical quantity (value + unit) datatype
3     length lentgh length (value + unit) datatype
3     volume volume volume (value + unit) datatype
2   portion portion datatype
1 format format format of certain data true abstract
2   dateTimeFormat date/time formats format
3     dateYYYY format as YYYY format
3     dateYYYYMM format as YYYY-MM format
3     dateYYYYMMDD format as YYYY-MM-DD format
2   timeFormat time formats format
2   stringFormat string formats any sequence of characters format
3     numericFormat numeric format any sequence of numbers format
3     alphanumericFormat alphanumeric format any sequence of printable characters format
1 procedure procedure procedure to perform when handling the product true abstract
2   documenting documenting procedure
3     labeling labeling creating and attaching a label procedure
4       relabeling relabeling attaching a new label (different from the original) procedure legal
3     formatting formatting data procedure
2   storing storing procedure
3     storingAfterUse storing after use procedure
2   preparing preparing for use procedure
3     assembling assembling for use procedure legal
3     calibrating calibrating for use procedure
2   manufacturing manufacturing manufacturing of the product procedure
3     testing testing procedure
3     repairing repairing procedure
3     packaging packing procedure
4       repackaging re-packaging procedure
3     qualityControl quality control procedure
3     riskManagement managing risks procedure
3     registering registering registration of the MD in an official registry, eg the EUDAMED UDI and device registration module procedure legal
2   transport transport transporting the product procedure
3     importing importing procedure
3     distributing distributing procedure
2   installing installing installing the product procedure
2   sterilizing sterilizing desinfection procedure
2   maintaining maintaining procedure
2   using using procedure
3     reprocessing reprocessing preparing for a second use refurbishing procedure legal
3     refurbishing refurbishing preparing for a second use procedure
2   training training procedure
2   disposing disposing procedure
2   measuring measuring the device has a measuring function procedure
1 property special property values list of properties that can be assigned to the medical device or attributes the properties may later be associated with something else true abstract
2   uniqueNumber the number or identifier is unique property eindeutig
2   sterile sterile property steril
2   nonSterile non-sterile property
2   sealed sealed property versiegelt
2   clinicalInvestigationOnly for clinical investigation only property legal nur für klinische Untersuchungen
2   inVitroDiagnosticsUse for in-vitro diagnostics use property legal
2   calibrated calibrated property kalibriert
2   detachable detachable detachable or removable property abnehmbar/entfernbar
2   consumable consumable property verschluckbar
2   legible legible property lesbar
2   packagingLayer packaging layer may be a model element? property Packungslagen
2   accuracy accuracy property
2   frequencyOfResponse frequency of response property
2   reprocessingLimit max number of reprocessing the device property legal
2   latency latency property Latenz
2   bandwidth bandwidth property Bandbreite
2   dataRate data rate property Datenrate
2   timeSynchronization time synchronization property
2   color color color (code) property Farbe
2   strength strength property Stärke
2   commercialProduct commercial product property kommerzielles Produkt
2   registered registered property registriert
1 text special texts special textual strings or wordings to be used true abstract
2   txtLotNumber LOT NUMBER text
2   txtSerialNumber SERIAL NUMBER text
2   txtExclusively4ClinicalUse exclusively for clinical use text
2   txtExclusively4ClinicalInvestigation exclusively for clinical investigation text
1 codesystem special codes/values probably codes or values to select from; they must be separated into distinct code systems true abstract
2   hint hint on error/warning codesystem Hinweis
3     error error code Fehler
3     warning warning code Warnung
3     precaution pre-caution code
3     contraIndication contraindication code Kontraindikation
2   purposeType type of purpose codesystem Zweck
3     diagnostics diagnostics code diagnostisch
3     monitoring monitoring code
3     prevention prevention code Prävention
3     treatment treatment code Behandlung
3     alleviationOfDisease alleviation of disease code
3     compensationForInjury compensation for injury code
3     replacement replacement code
3     modification modification code
3     desinfection desinfection code
3     investigation investigation code
3     providingInVitroData providingInVitroData code
3     controlConception controlConception code
3     supportingLife supporting of sustaining life code
3     supportingAnatomy supporting the anatomy code
3     supportingPhysiologicalProcess supporting a physiological process code
2   deviceFamily device family codesystem
2   deviceClass class of device codesystem
3     deviceClass1 class 1 low risk code
3     deviceClass2 class 2 code
4       deviceClass2a class 2a low-to-medium risk code
4       deviceClass2b class 2b medium-to-high risk code
3     deviceClass3 class 3 high risk code
2   deviceType type of device same as device family? codesystem
3     implant implant code
3     ivd IVD in-vitro device code
2   edocumentationCarrier carrier of e-documentation codesystem
3     cdrom CD-ROM code
3     dvd DVD code
3     usb usb device code
3     websiteCarrier website (as carrier of information) code
2   multipleUse possible multiple use codesystem
3     multiplePatientMultipleUse multiple patient, multiple use code
3     singlePatientMultipleUse single patient, multiple use code
3     singlePatientSingleUse single patient, single use code
3     singleUse single use code
3     noReuse no re-use code
3     normalUse normal use code
4       standBy stand-by code
4       routine routine code
4       inspection inspection code
2   useEnvironment use environment
3     useAtHome at home code
3     useInClinic in clinic code
2   useSpecification use specification codesystem
2   subjectOfCare subject of care subject of care, normally the patient itself codesystem, model
3     subjectPerson person (as subject) code
4       patient patient code
3     subjectAnimal animal (as subject) code
2   sizeLimit size limit
3     smallSize small size the item is (too) small in its size code
3     normalSize normal size the item has normal size for use code
3     largeSize large size the item is relatively big in its size code
2   timing timing codesystem
3     absoluteTiming absolute timing code
3     relativeTiming absolute timing code
4       maxCycleTiming timing maximum cycles code
2   humanBehavior human behavior codesystem menschliches Verhalten
3     limitation limitation code Limitierung
3     ability ability code Fähigkeit
3     skill skill code Fähigkeit?
3     knowledge knowledge code Wissen
3     education education code Ausbildung
2   condition condition condition(s) under which the medical devices can be operated codesystem Bedingung
3     transportCondition transport condition code Transport
3     handlingCondition handling condition code Handhabung
3     storageCondition storage condition code Lagerung
3     environmentCondition environmental condition codesystem Umgebung
4       hygienicCondition hygienic condition code Hygiene
4       frequencyOfUseCondition frequency of use condition code
4       locationCondition location condition code Örtlichkeit
5         cleanRoomCondition clean room condition code Reinraum
5         magneticFieldCondition magnetic field condition code
4       lightningCondition lightning condition code Beleuchtung
4       radiationCondition radiation condition code legal Strahlung
4       electricCondition electric condition code
5         electricDischargeCondition electric discharge condition code
4       noiseCondition noise condition code
4       pressureCondition pressure condition code
4       temperatureCondition temperature condition code
4       humidityCondition humidity condition code
4       sterileCondition sterile condition code
4       mobilityCondition mobility condition code
4       degreeOfInternantionalizationCondition degree of internationalization condition code
4       exclusiveCondition exclusive condition restrictions on combinations with other devices or equipment code legal
4       socialCondition social condition code
5         teamCondition team condition code
5         individudalCondition individual condition code
5         chaoticCondition chaotic condition code
5         calmCondition calm condition code
5         stressLevelCondition stress level condition code
5         stressLengthCondition stress length condition code
2   stability stability of the product codesystem Stabilität
2   countryCode country code ISO 3166 country codes codesystem Ländercodes
2   languageCode language code ISO 639 language codes codesystem Sprachcodes
2   methodOfSterilization method of sterilization codesystem
2   methodOfRiskElimination method of risk elimination codesystem legal
3     methodOfRadiationProtection protective measure against radiation codesystem legal
2   origin origin codesystem Ursprung
3     biologicalOrigin biological origin code biolog. Ursprung
4       humanOrigin human origin code legal menschl. Ursprung
4       animalOrigin animal origin code legal tier. Ursprung
2   containment contains ... codesystem Inhalt
3     containsMedicalSubstance contains medical substance code
3     containsNanoParticle contains nano particles code
3     containsHazardousSubstance contains hazardous substance code
2   multipleLanguages necessity of multiple languages
3     multipleLanguageNeeded multiple language needed
3     multipleLanguageNotNeeded multiple language not needed
2   symbol symbols codesystem Symbole
3     symbolOnPackage symbols on package what is meant by this? abstract Symbol auf der Verpackung
3     symbolIso7000 iso 7000 symbols complete list to be provided codesystem
4       symbolIso7000-1051 1051 symbol ISO 7000: 1051 (do not re-use) code
4       symbolIso7000-1641 1641 symbol ISO 7000: 1641 code
4       symbolIso7000-2492 2492 symbol ISO 7000: 2492 code
4       symbolIso7000-2493 2493 symbol ISO 7000: 2493 code
4       symbolIso7000-2497 2497 symbol ISO 7000: 2497 code
4       symbolIso7000-2499 2499 symbol ISO 7000: 2499 code
4       symbolIso7000-2500 2500 symbol ISO 7000: 2500 code
4       symbolIso7000-2501 2501 symbol ISO 7000: 2501 code
4       symbolIso7000-2502 2502 symbol ISO 7000: 2502 code
4       symbolIso7000-2503 2503 symbol ISO 7000: 2503 code
4       symbolIso7000-2607 2607 symbol ISO 7000: 2607 code
4       symbolIso7000-2725 2725 symbol ISO 7000: 2725 (hazardous substance, eg latex) code
4       symbolIso7000-3082 3082 symbol ISO 7000: 3082 code
4       symbolIso7000-3699 3699 symbol ISO 7000: 3699 code
4       symbolIso7000-3700 3700 symbol ISO 7000: 3700 code
4       symbolIso7000-3701 3701 symbol ISO 7000: 3701 code
4       symbolIso7000-3702 3702 symbol ISO 7000: 3702 code
4       symbolIso7000-3703 3703 symbol ISO 7000: 3703 code
4       symbolIso7000-3706 3706 symbol ISO 7000: 3706 (single patient multiple use) code
4       symbolIso7000-3723 3723 symbol ISO 7000: 3723 (endocrine disrupting, carcinogenic, mutagenic or toxic ror reproduction substances) code
4       symbolIso7000-6041 6041 symbol ISO 7000: 6041 (instructions for use) code
3     symbolIso7010 iso 7010 safety signs codesystem
4       symbolIso7010-M001 M001 safety sign ISO 7010: M001 code
4       symbolIso7010-M002 M002 safety sign ISO 7010: M002 code
4       symbolIso7010-P001 P001 safety sign ISO 7010: P001 code
4       symbolIso7010-W001 W001 safety sign ISO 7010: W001 code
3     symbolIso15223 iso 15223 complete list to be provided codesystem
4       symbolIso15223-5.1.1 5.1.1: manufacturer symbol 5.1.1 from ISO 15223: manufacturer code
4       symbolIso15223-5.1.3 5.1.3: date of manufacture symbol 5.1.3 from ISO 15223: date of manufacture code
4       symbolIso15223-5.1.4 5.1.4: date safe to use symbol 5.1.4 from ISO 15223: date safe to use code
4       symbolIso15223-5.1.5 5.1.5: lot number symbol 5.1.5 from ISO 15223: lot number code
4       symbolIso15223-5.1.6 5.1.6: catalog number symbol 5.1.6 from ISO 15223: catalog number code
4       symbolIso15223-5.1.7 5.1.7: serial number symbol 5.1.7 from ISO 15223: serial number code
4       symbolIso15223-5.1.12 5.1.12: authorized representative symbol 5.1.12 from ISO 15223: authorized representative code
4       symbolIso15223-5.2.1 5.2.1 symbol 5.2.1 from ISO 15223 code
4       symbolIso15223-5.2.2 5.2.2 symbol 5.2.2 from ISO 15223 code
4       symbolIso15223-5.2.3 5.2.3 symbol 5.2.3 from ISO 15223 code
4       symbolIso15223-5.2.4 5.2.4 symbol 5.2.4 from ISO 15223 code
4       symbolIso15223-5.2.5 5.2.5 symbol 5.2.5 from ISO 15223 code
4       symbolIso15223-5.2.10 5.2.10 symbol 5.2.10 from ISO 15223 code
4       symbolIso15223-5.4.2 5.4.2: do not re-use symbol 5.4.2 from ISO 15223: do not re-use code
4       symbolIso15223-5.4.3 5.4.3: instructions for use symbol 5.4.3 from ISO 15223: instructions for use code
4       symbolIso15223-5.4.5 5.4.5: latex symbol 5.4.5 from ISO 15223: latex code
4       symbolIso15223-5.4.6 5.4.6 symbol 5.4.6 from ISO 15223: contains human blood or plasma derivatives code
4       symbolIso15223-5.4.7 5.4.7 symbol 5.4.7 from ISO 15223: contains medicinal substances code
4       symbolIso15223-5.4.8 5.4.8 symbol 5.4.8 from ISO 15223: contains biological material of animal origin code
4       symbolIso15223-5.4.9 5.4.9 symbol 5.4.9 from ISO 15223 code
4       symbolIso15223-5.4.10 5.4.10 symbol 5.4.10 from ISO 15223: endocrine disrupting, carcinogenic, mutagenic or toxic to reproduction substances code
4       symbolIso15223-5.4.11 5.4.11 symbol 5.4.11 from ISO 15223: contains nanotech materials code
4       symbolIso15223-5.4.12 5.4.12 symbol 5.4.12 from ISO 15223: single patient multiple use code
4       symbolIso15223-5.7.10 5.7.10 symbol 5.7.10 from ISO 15223: UDI carrier code
3     symbolIec60417 iec 60417 codesystem
4       symbolIec60417-6050 6050 symbol 6050 from IEC 60417 code
3     symbolEn15986 en 15986 codesystem
4       symbolEn15986-xxx xxx symbol ???? from EN 15986 (phthalates) code
2   instructionCommand instructon (command) instructions to be used as a command codesystem
3     doNotUse do not use code
3     doNotReuse do not re-use code
3     doNotOpen do not open code
3     doNotDrop do not drop code
3     wearGlove wear glove code
3     keepAwayFrom keep away from ... code
3     scrubBeforeEntering scrub before entering code
2   userType type of user codesystem
3     professional professional code
4       healthProfessional health professional any health professional code
5         physician physician code
5         assistant (medical/technical) assistant code
3     servicePersonnel service personnel code
3     informedPatient informed patient code
3     caregiver caregiver code
3     layUser lay user code
3     processor processor code
2   maintenanceType type of maintenance codesystem
3     regular regular maintenance code
3     preventive preventive maintenance code
2   powering powering of device codesystem
3     batteryPowered powered by batteries code
3     powerGrid attached to normal power grid code
2   durabilityOfMarking durability of markings codesystem
3     waterResistant water resistant code
3     uvResistant UV resistant code
3     durableThruLifetime durable through normal/declared lifetime code
3     durableThruShelfLife durable through shelf-life code
2   usability usability codesystem
2   efficiency efficency codesystem
2   satisfaction satisfaction codesystem
2   readability readability of label codesystem
3     humanReadable normal readability by humans code
3     machineReadable readability by a machine code
3     braille braille raadable by blind code
2   authorityLevel level of authorization codesystem
3     responsible responsible code
3     havingJurisdiction authority having jurisdiction code
2   informationForm form of information codesystem
3     auditory auditory code
3     electronic electronic code
4       rfid rfid code
3     multimedia multi-media code
3     printed printed printed/written code
4       barcode barcode barcode code
5         qrcode QR code QR code code
5         linearbarcode linear barcode linear barcode code
5         matrixcode matrix barcode matrix barcode code
3     tactile tactile code
1 actor actor concepts what are the actors involved with digital labels is this hierarchy needed? Actors - as organisations - are already added true
2   manufacturer manufacturer organisation that produces the product organization needs assignment to a role? actor Hersteller
2   distributor distributor who distributes the product? organization actor Distributeur
2   importer importer organization who imports a product that was manufactured in one locale into another locale for the purposes of marketing organization actor Importeur
2   packagingProducer packaging producer organization actor legal
1 precoordinatedConcept pre-coordinated concepts following a list of items that are a precoordination of other concepts in order to simplify the collection and indication of requirements true
2   manufacturerInformation manufacturer information information provided by manufacturer information
2   manufacturerAddress manufacturer address address of manufacturer address
2   electronicInstruction electronic instruction instruction
2   electronicInterface electronic interface interface
2   edocumentation e-documentation form of electronically accessible information supplied by the manufacturer document
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 authority
2   authorizedRepresentative authorized representative organization 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
2   countryOfOrigin country of origin country Ursprungsland
2   labelModelNumber model number on label model number on a label modelNumber
2   hybridLabel hybrid Label label in printed and digital format printedLabel, digitalLabel hybrides Label
2   registeredPlaceOfBusiness registered place of business what is the manufacturer registered address address registrierte Geschäftsadresse
2   assemblerName name of assembler name of person that assembles the device name legal
2   conformityAssessmentOrg organisation performing the conformity assessment organization legal
2   conformityAssessmentOrgID ID of organisation performing the conformity assessment identifier legal
2   humanBlood human blood legal
2   plasmaDerivative plasma derivative legal
2   tissue tissue legal
2   humanCell human cell legal
2   animalCell animal cell legal
2   eudamed European Database on Medical Devices (EUDAMED) organization legal
2   AIsystem AI system legal
3     generativeAIsystem generative AI system legal

Notes:

The listed items (as concept codes) are still under development and further specialisation, and cannot be treated as either complete or correct! As a consequence, they may change their code and/or their meaning.