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Source1
{
"resourceType": "StructureDefinition",
"url": "https://fhir.trustedhealthapps.org/StructureDefinition/HealthAppModuleMedicalDevice",
"version": "1.1.6",
"name": "HealthAppModuleMedicalDevice",
"title": "MedicalDevice on HealthAppModule",
"status": "active",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "DeviceDefinition"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Medizinprodukt",
"definition": "Angaben zum Medizinprodukt",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"rules": "open"
}
},
{
"id": "Extension.extension:intendedPurpose",
"path": "Extension.extension",
"sliceName": "intendedPurpose",
"short": "Medizinische Zweckbestimmung",
"definition": "Medizinische Zweckbestimmung entsprechend den Angaben des Herstellers auf der Kennzeichnung, in der Gebrauchsanweisung oder dem Werbe- oder Verkaufsmaterial bzw. den Werbe- oder Verkaufsangaben.",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:intendedPurpose.url",
"path": "Extension.extension.url",
"fixedUri": "intendedPurpose"
},
{
"id": "Extension.extension:intendedPurpose.value[x]",
"path": "Extension.extension.value[x]",
"min": 1,
"type": [
{
"code": "string"
}
],
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody",
"path": "Extension.extension",
"sliceName": "notifiedBody",
"short": "Benannte Stelle",
"definition": "Angaben zur benannten Stelle.",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"rules": "open"
}
},
{
"id": "Extension.extension:notifiedBody.extension:code",
"path": "Extension.extension.extension",
"sliceName": "code",
"short": "Kennnummer",
"definition": "Kennnummer der benannten Stelle.",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody.extension:code.url",
"path": "Extension.extension.extension.url",
"fixedUri": "code"
},
{
"id": "Extension.extension:notifiedBody.extension:code.value[x]",
"path": "Extension.extension.extension.value[x]",
"min": 1,
"type": [
{
"code": "string"
}
],
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody.extension:name",
"path": "Extension.extension.extension",
"sliceName": "name",
"short": "Name",
"definition": "Name der benannten Stelle.",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody.extension:name.url",
"path": "Extension.extension.extension.url",
"fixedUri": "name"
},
{
"id": "Extension.extension:notifiedBody.extension:name.value[x]",
"path": "Extension.extension.extension.value[x]",
"min": 1,
"type": [
{
"code": "string"
}
],
"mustSupport": true
},
{
"id": "Extension.extension:notifiedBody.url",
"path": "Extension.extension.url",
"fixedUri": "notifiedBody"
},
{
"id": "Extension.extension:notifiedBody.value[x]",
"path": "Extension.extension.value[x]",
"max": "0"
},
{
"id": "Extension.extension:regulatoryBasis",
"path": "Extension.extension",
"sliceName": "regulatoryBasis",
"short": "Regulatorische Grundlage",
"definition": "+ mdd: Medical Device Directive\r\n+ mdr: Medical Device Regulation",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:regulatoryBasis.url",
"path": "Extension.extension.url",
"fixedUri": "regulatoryBasis"
},
{
"id": "Extension.extension:regulatoryBasis.value[x]",
"path": "Extension.extension.value[x]",
"min": 1,
"type": [
{
"code": "code"
}
],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "https://fhir.trustedhealthapps.org/ValueSet/HealthAppRegulatoryBasis"
}
},
{
"id": "Extension.extension:riskClass",
"path": "Extension.extension",
"sliceName": "riskClass",
"short": "Risikoklasse",
"definition": "+ unknown: Nicht verwendet\r\n+ 1: Risikoklasse I\r\n+ 2a: Risikoklasse IIa\r\n+ 2b: Nicht verwendet\r\n+ 3: Nicht verwendet",
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:riskClass.url",
"path": "Extension.extension.url",
"fixedUri": "riskClass"
},
{
"id": "Extension.extension:riskClass.value[x]",
"path": "Extension.extension.value[x]",
"min": 1,
"type": [
{
"code": "code"
}
],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "https://fhir.trustedhealthapps.org/ValueSet/HealthAppRiskClass"
}
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "https://fhir.trustedhealthapps.org/StructureDefinition/HealthAppModuleMedicalDevice"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}