MedTechLabel WP2 T2.2 Information Model Guide
0.4.15 - ci-build
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
The Library of Digital Label Elements
| MindMap |
This Logical Model is used to document the details of the mindmap for MedTechLabel and is therefore just a serialization of the mindmap. |
The Library of Digital Label Elements
| Digital Label Element |
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. |
Two distinct approaches to specify an ontology for digital label elements.
| Digital Label Element ConceptMap Ontology |
Digital Label Ontology (based on ConceptMap) |
| Digital Label Element Property Ontology |
Ontology that supplements the Digital Label Elements (based on Supplement) |
Mapping of digital label elements to other concepts
| DigLblElement -> ISO 7000 |
Digital Label Element -> ISO 7000 |
| DigLblElement -> ISO 7010 |
Digital Label Element -> ISO 7010 |
These define sets of codes used by systems conforming to this implementation guide.
| Codesystems for Digital Label Elements |
Codesystems for Digital Label Elements |
| Digital Label Element |
all concept/items from Digital Label Element |
| Digital Label Element Property Ontology |
Ontology that supplements the Digital Label Elements (based on Supplement) |
| Digital Label Element Type |
Type of Digital Label Element |
| Digital Label Element as codes |
Digital Label Element items needed as codes |
| Digital Label Element as procedures |
Digital Label Element items needed as procedures |
| Digital Label Element for information model |
Digital Label Element items needed for the information model |
| Digital Label Element objects |
objects from Digital Label Elements |
| Digital Label Element precoordinated concepts |
pre-coordinated concepts from Digital Label Elements |
| ISO 7010: Safety Signs |
ISO 7010 - Safety Signs |
| ISO 7010: Safety categories |
ISO 7010 - Safety categories |
| OID |
OIDs used in this IG |
| Properties for Digital Label Elements |
Properties for Digital Label Elements |
| Property |
Property |
| Relationship |
Relationship |
| Standards used with Digital Label Elements |
standards used with Digital Label Elements |
| Symbols7000 |
Symbols7000 |
These define new code systems used by systems conforming to this implementation guide.
| Data Element Role Category |
Category to classify the data elements |
| Device Class |
Medical devices are categorized based on their risk level, invasiveness, and duration of contact with the body. Regulatory bodies, such as the FDA in the US and authorities under the EU MDR. |
| Device Property |
property for all types of devices |
| Device Type |
all types of devices |
| Digital Label Element Type |
Type of Digital Label Element |
| ISO 14617: Graphical symbols for diagrams |
ISO 14617 - Graphical symbols for diagrams |
| ISO 15223: Medical devices — Symbols to be used with information to be supplied by the manufacturer |
ISO 15223 - Medical devices — Symbols to be used with information to be supplied by the manufacturer |
| ISO 7000: Graphical Symbols for use on Equipment |
ISO 7000 - Graphical Symbols for use on Equipment |
| ISO 7010: Safety categories |
ISO 7010 - Safety categories |
| ISO 7010: Safety colours and safety signs |
ISO 7010 - Safety colours and safety signs |
| Material Origin |
origin of material - currently contains values from 2 different axes - requires harmonization |
| OID |
OIDs used in this IG |
| Property |
Property |
| Relationship |
Relationship |
| Requirement |
Requirements as a foundation It is unclear whether a representation of requirements as a codesystem with properties is appropriate or not. Therefore, it is for the moment just for information purposes. |
| Safety Sign Statement |
ISO 20417 requires to attach statements to the Safety Sign that explains what needs to be considered. |
| Standard |
Standards or any other kind of basic documentation like specifications that are used or referenced here |
| Use |
how is the device to be used? |