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Packagemedtechlabel
Resource TypeImplementationGuide
IdImplementationGuide-medtechlabel.json
FHIR VersionR4
Sourcehttps://build.fhir.org/ig/hl7-eu/medtechlabel-wp2-im/index.html
URLhttp://www.hl7europe.org/medtechlabel/ImplementationGuide/medtechlabel
Version0.4.9
Statusdraft
Date2026-10-09
NameMedTechLabel
TitleMedTechLabel WP2 T2.2 Information Model Guide
Authorityhl7
DescriptionWP2 T2.2 Information Model for Device Labeling (D2.2, M13)

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ImplementationGuide medtechlabel

MedTechLabel

The official URL for this implementation guide is:

http://www.hl7europe.org/medtechlabel/ImplementationGuide/medtechlabel

WP2 T2.2 Information Model for Device Labeling (D2.2, M13)


Source1

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        "name": "Digital Label Element",
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        "description": "objects from **Digital Label Element**s",
        "exampleBoolean": false
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        "name": "Digital Label Element precoordinated concepts",
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        "reference": {
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        "name": "DigitalLabelOntology",
        "description": "Digital Label Ontology (based on ConceptMap)",
        "exampleBoolean": false,
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        "description": "Digital Label Element -> ISO 7010",
        "exampleBoolean": false,
        "groupingId": "GroupD"
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          {
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          }
        ],
        "reference": {
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        },
        "name": "ISO 14617: Graphical symbols for diagrams",
        "description": "**ISO 14617** - Graphical symbols for diagrams",
        "exampleBoolean": false
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      {
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            "valueUri": "CodeSystem-Symbols15223.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Symbols15223"
        },
        "name": "ISO 15223: Medical devices — Symbols to be used with information to be supplied by the manufacturer",
        "description": "**ISO 15223** - Medical devices — Symbols to be used with information to be supplied by the manufacturer",
        "exampleBoolean": false
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        "reference": {
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        "name": "ISO 7000: Graphical Symbols for use on Equipment",
        "description": "**ISO 7000** - Graphical Symbols for use on Equipment",
        "exampleBoolean": false
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          }
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        "name": "ISO 7010: Safety categories",
        "description": "ISO 7010 - Safety categories",
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      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-MaterialOrigin.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/MaterialOrigin"
        },
        "name": "Material Origin",
        "description": "origin of material - currently contains values from 2 different axes - requires harmonization",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:logical"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "StructureDefinition-MindMap.html"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/MindMap"
        },
        "name": "MindMap",
        "description": "This Logical Model is used to document the details of the **mindmap for MedTechLabel** and \nis therefore just a serialization of the [mindmap](model.html).",
        "exampleBoolean": false,
        "groupingId": "GroupA"
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-OID.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/OID"
        },
        "name": "OID",
        "description": "**OID**s used in this IG",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-OID.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/OID"
        },
        "name": "OID",
        "description": "**OID**s used in this IG",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-DigitalLabelElement4Property.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/DigitalLabelElement4Property"
        },
        "name": "Properties for Digital Label Elements",
        "description": "**Properties** for **Digital Label Elements**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-Property.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/Property"
        },
        "name": "Property",
        "description": "**Property**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-Property.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Property"
        },
        "name": "Property",
        "description": "**Property**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-Relationship.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/Relationship"
        },
        "name": "Relationship",
        "description": "**Relationship**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-Relationship.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Relationship"
        },
        "name": "Relationship",
        "description": "**Relationship**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-Requirement.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Requirement"
        },
        "name": "Requirement",
        "description": "**Requirements** as a foundation\n\nIt is unclear whether a representation of requirements as a codesystem \nwith properties is appropriate or not.\nTherefore, it is for the moment just for information purposes.",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-SafetySignStatement.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/SafetySignStatement"
        },
        "name": "Safety Sign Statement",
        "description": "ISO 20417 requires to attach statements to the Safety Sign that explains what needs to be considered.",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-Standard.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Standard"
        },
        "name": "Standard",
        "description": "**Standards** or any other kind of basic documentation like specifications that are used or referenced here",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-DigitalLabelElement4Standard.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/DigitalLabelElement4Standard"
        },
        "name": "Standards used with Digital Label Elements",
        "description": "standards used with **Digital Label Element**s",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "ValueSet-Symbols7000.html"
          }
        ],
        "reference": {
          "reference": "ValueSet/Symbols7000"
        },
        "name": "Symbols7000",
        "description": "**Symbols7000**",
        "exampleBoolean": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          },
          {
            "url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
            "valueUri": "CodeSystem-Use.html"
          }
        ],
        "reference": {
          "reference": "CodeSystem/Use"
        },
        "name": "Use",
        "description": "how is the device to be used?",
        "exampleBoolean": false
      }
    ],
    "page": {
      "extension": [
        {
          "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
          "valueUrl": "toc.html"
        }
      ],
      "nameUrl": "toc.html",
      "title": "Table of Contents",
      "generation": "html",
      "page": [
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "index.html"
            }
          ],
          "nameUrl": "index.html",
          "title": "MedTechLabel",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "framework.html"
            }
          ],
          "nameUrl": "framework.html",
          "title": "Framework",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "model.html"
            }
          ],
          "nameUrl": "model.html",
          "title": "Model",
          "generation": "markdown",
          "page": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
                  "valueUrl": "mindmap.html"
                }
              ],
              "nameUrl": "mindmap.html",
              "title": "Mindmap",
              "generation": "markdown"
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
                  "valueUrl": "taxonomy.html"
                }
              ],
              "nameUrl": "taxonomy.html",
              "title": "Taxonomy + Abstract Model",
              "generation": "markdown"
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
                  "valueUrl": "informationmodel.html"
                }
              ],
              "nameUrl": "informationmodel.html",
              "title": "Information Model",
              "generation": "markdown"
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
                  "valueUrl": "profiling.html"
                }
              ],
              "nameUrl": "profiling.html",
              "title": "Profiling of the Model",
              "generation": "markdown"
            }
          ]
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "glossary.html"
            }
          ],
          "nameUrl": "glossary.html",
          "title": "Glossary of Terms",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "cooperation.html"
            }
          ],
          "nameUrl": "cooperation.html",
          "title": "WP Cooperation",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "terms.html"
            }
          ],
          "nameUrl": "terms.html",
          "title": "Terms",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "installation.html"
            }
          ],
          "nameUrl": "installation.html",
          "title": "Installation",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "notation.html"
            }
          ],
          "nameUrl": "notation.html",
          "title": "Notation",
          "generation": "markdown"
        },
        {
          "extension": [
            {
              "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
              "valueUrl": "ip_statement.html"
            }
          ],
          "nameUrl": "ip_statement.html",
          "title": "IP Statement",
          "generation": "markdown"
        }
      ]
    },
    "parameter": [
      {
        "code": "path-resource",
        "value": "input/capabilities"
      },
      {
        "code": "path-resource",
        "value": "input/examples"
      },
      {
        "code": "path-resource",
        "value": "input/extensions"
      },
      {
        "code": "path-resource",
        "value": "input/models"
      },
      {
        "code": "path-resource",
        "value": "input/operations"
      },
      {
        "code": "path-resource",
        "value": "input/profiles"
      },
      {
        "code": "path-resource",
        "value": "input/resources"
      },
      {
        "code": "path-resource",
        "value": "input/vocabulary"
      },
      {
        "code": "path-resource",
        "value": "input/maps"
      },
      {
        "code": "path-resource",
        "value": "input/testing"
      },
      {
        "code": "path-resource",
        "value": "input/history"
      },
      {
        "code": "path-resource",
        "value": "fsh-generated/resources"
      },
      {
        "code": "path-pages",
        "value": "template/config"
      },
      {
        "code": "path-pages",
        "value": "input/images"
      },
      {
        "code": "path-tx-cache",
        "value": "input-cache/txcache"
      }
    ]
  }
}