MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions
| Official URL: http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement4Model | Version: 0.4.3 | |||
| Active as of 2026-08-20 | Computable Name: DigitalLabelElement4ModelVS | |||
| Other Identifiers: OID:1.2.3.4.5.6.7.8.10.50 | ||||
Copyright/Legal: FO |
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Digital Label Element items needed for the information model
References
This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)
http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement version 📦0.4.3 where dleType = model
Expansion performed internally based on codesystem Digital Label Element v0.4.3 (CodeSystem)
This value set contains 86 concepts
| Level | System | Code | Display (en) | Definition | JSON | XML |
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | product | product | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | 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) | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | sparePart | spart part | spare part replacing whole or part of the original medical device | ||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | battery | battery | battery providing electrical power to a medical device | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | component | component | component of the medical device | ||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | detachableComponent | detachable component | detachable component of the medical device | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | accessory | accessory | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | consumableComponent | consumable component | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | container | container | box containing the items | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | package | package | outer container declared as the complete product | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | organization | organisation | any kind of an organization being involved | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | manufacturer | manufacturer | organisation that produces the product | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | person | Person | person | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | label | Label | label for medicinal product | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | secondaryLabel | 2nd Label | any other label provided for medicinal product | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | document | document | any kind of a document | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | shippingDocument | shipping document | document that is shipped with the product | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | packagingList | packaging list | list of items packaged with the product | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | technicalDescription | technical description | description with technical details | ||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | installationManual | installation manual | manual describing the installation of the product | ||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | quickReferenceGuide | quick reference guide | |||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | protocol | protocol | protocol of electronic interface | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | purpose | purpose | purpose of use | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | information | information | any kind of information about the product | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | addtlInfo | additional information | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | accompanyingInfo | accompanying information | information supplied by the manufacturer | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | generalInfo | general information | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | packagingInfo | packaging information | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | safetyInfo | safety information | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | markingInfo | marking | information, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to a product | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | instruction | instruction | any kind of instruction for someone | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | specialOperatingInstruction | special operating instruction | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | instructionForUse | instruction for use | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | requirement | requirement | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | intendedUse | intended use | description of the intended use (normally in combination with any risk) | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | criticalCharacteristic | critical characteristics | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | 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 | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | software | software | software used in conjunction with the medical device | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | identifier | identifier | any kind of identifier | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | catalogNumber | catalog number | number in a catalog | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | productIdentifier | product identifier | product identifier | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | productionControlIdentifier | production control identifier | production control identifier | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | lotNumber | lot number | lot number | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | modelNumber | model number | model number | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | serialNumber | serial number | serial number | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | versionIdentifier | verison identifier | version identifier^ | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | donorIdentifier | donor identifier | identifier for the donor | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | udi | UDI | unique device identifier | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | url | url | URL or webaddress | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | name | name | name of something, eg. person, organisation, product | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | personName | person name | name of a person | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | organizationName | organization name | name of an organization | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | productName | name of the product | |||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | tradeName | trade name | trade name for the product | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | address | address | address and parts thereof | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | street | street | street name | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | number | number | number/house/floor | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | city | city | city | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | state | state | (federal) state | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | region | region | region (by name) | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | postalCode | postal code | postal or ZIP code | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | country | country | country as string or code (ISO 3166) | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | description | description | a long description | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | expectedLifeTime | expected lifetime | period specified by the manufacturer during which the product is expected to remain safe and effective for use | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | absoluteExpectedLifeTime | absolute | absolute expected lifetime | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | relativeExpectedLifeTime | relative | relative expected lifetime | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | expectedServiceTime | expected service Time | expected time this product is in service | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | usageCount | usage count | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | usageCountByCycle | usage count by cycle (repetitions) | |||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | usageCountByTime | usage count by time (period of time^) | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | productionDate | production date | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | size | size | size | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | physicalSize | physical size | physical size of the medical device | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | packagingSize | packaging size | packaging size of the medical device in form of contained items | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | dateSafeForUse | date until safe for use | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | revisionDate | revision date | |||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | statement | statement | any kind of a statement | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | justification | justification | justification for (the omission) of an activity | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | contactInformation | contact | contact information | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | telephoneNumber | telephone | telephone number | ||
| 3 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | mobilePhone | mobile | mobile phone number | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | email address | ||||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | fax | fax | telefax | ||
| 2 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | website | website | (url of) website | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | shelfLife | shelf-life | period during which a product maintains its stability | ||
| 1 | http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement | subjectOfCare | subject of care | subject of care, normally the patient itself |
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 |