Digital Label Element objects - MedTechLabel WP2 T1.1 Information Model Guide v0.4.3

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

ValueSet: Digital Label Element objects

Official URL: http://www.hl7europe.org/medtechlabel/ValueSet/DigitalLabelElement4Object				Version: 0.4.3
Active as of 2026-08-20				Computable Name: DigitalLabelElement4ObjectVS
Other Identifiers: OID:1.2.3.4.5.6.7.8.10.51
Copyright/Legal: FO

objects from Digital Label Elements

References

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

Logical Definition (CLD)

Include codes fromhttp://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement version 📦0.4.3 where concept is-a object

Expansion

Expansion performed internally based on codesystem Digital Label Element v0.4.3 (CodeSystem)

This value set contains 89 concepts

Level	System	Code	Display (en)	Inactive	Definition	status	JSON	XML
1	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	object	any kind of object	inactive	basic information objects for our model; these must be represented in the information model as classes	inactive
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	physicalObject	physical Object		an object that physically exists
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	product	product
4	`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)
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	sparePart	spart part		spare part replacing whole or part of the original medical device
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	battery	battery		battery providing electrical power to a medical device
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	component	component		component of the medical device
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	detachableComponent	detachable component		detachable component of the medical device
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	accessory	accessory
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	consumableComponent	consumable component
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	container	container		box containing the items
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	package	package		outer container declared as the complete product
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	organization	organisation		any kind of an organization being involved
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	manufacturer	manufacturer		organisation that produces the product
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	countryOfOrigin	country of origin
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	distributor	distributor		who distributes the product?
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	importer	importer		organization who imports a product that was manufactured in one locale into another locale for the purposes of marketing
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	person	Person		person
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	naturalPerson	natural person		natural person
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	jurisdictionalPerson	jurisdictional person		jurisdictional person
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	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
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	animal	Animal		animal
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	label	Label		label for medicinal product
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	secondaryLabel	2nd Label		any other label provided for medicinal product
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	document	document		any kind of a document
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	shippingDocument	shipping document		document that is shipped with the product
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	packagingList	packaging list		list of items packaged with the product
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	technicalDescription	technical description		description with technical details
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	installationManual	installation manual		manual describing the installation of the product
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	quickReferenceGuide	quick reference guide
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	protocol	protocol		protocol of electronic interface
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	specification	specification		specification
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	standard	standard		standard
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso639	ISO 639		ISO 639: language codes
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso3166	ISO 3166		ISO 3166: country codes
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso3864	ISO 3864		ISO 3864: colours for safety signs
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso7000	ISO 7000		ISO 7000: Graphical Symbols for use on Equipment
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso7010	ISO 7010		ISO 7010: Safety colours and safety signs
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso14617	ISO 14617		ISO 14617: Graphical symbols for diagrams
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso14971	ISO 14971		ISO 14971: Medical Devices - Applicaiton of Risk Management
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso15223	ISO 15223		ISO 15223: Medical devices - Symbols to be used with information to be supplied by the manufacturer
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso20417	ISO 20417		ISO 20417:2026
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iec60417	IEC 60417		IEC 60417: Medical devices - Graphical Symbols for use on Equipment (database)
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iso80000	ISO 80000		ISO 80000: Quantity and Units
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	iec60878	IEC/TR 60878		IEC/TR 60878
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	implementationGuide	IG		implementation guide
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	productSpecification	product specification
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	edocumentation	e-documentation		form of electronically accessible information supplied by the manufacturer
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	purpose	purpose		purpose of use
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	pictogram	pictogram		graphical representation of something
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	icon	icon		symbol or icon
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	information	information		any kind of information about the product
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	addtlInfo	additional information
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	accompanyingInfo	accompanying information		information supplied by the manufacturer
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	generalInfo	general information
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	packagingInfo	packaging information
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	safetyInfo	safety information
3	`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
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	instruction	instruction		any kind of instruction for someone
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	specialOperatingInstruction	special operating instruction
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	instructionForUse	instruction for use
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	requirement	requirement
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	risk	risk		risk when using the product
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	generalRisk	general risk
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	residualRisk	residual risk		remaining risk after mitigation
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	hazard	hazard
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	microbialHazard	microbial hazard
5	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	infection	infection
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	environmentalHazard	environmental hazard
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	radiationHazard	radiation hazard
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	allergicReactionHazard	allergic reaction hazard
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	riskControlMeasure	risk control measure
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	intendedUse	intended use		description of the intended use (normally in combination with any risk)
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	criticalCharacteristic	critical characteristics
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	environment	environment
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	interface	interface
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	policy	policy
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	applicablePolicy	applicable policy
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	authority	authority		any kind of an authority; could be an organisation or person
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	authorityHavingJurisdiction	authority having jurisdiction		governmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	role	role		role that someone plays
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	roleUser	user (role)
4	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	roleLayUser	lay user (role)
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	rolePatient	patient (role)
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	roleManufracturer	manufacturer (role)
3	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	roleProducer	producer (role)
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	jurisdiction	jurisdiction
2	`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
2	`http://www.hl7europe.org/medtechlabel/CodeSystem/DigitalLabelElement`	software	software		software used in conjunction with the medical device

Explanation of the columns that may appear on this page:

Level

A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies

System

The source of the definition of the code (when the value set draws in codes defined elsewhere)

Code

The code (used as the code in the resource instance)

Display

The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application

Definition

An explanation of the meaning of the concept

Comments

Additional notes about how to use the code