CH LAB-Report (R4)
0.1.1 - draft
CH LAB-Report (R4)
0.1.1 - draft
This page is part of the CH LAB-Report (R4) (v0.1.1: DSTU 1 Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
| Official URL: http://fhir.ch/ig/ch-lab-report/StructureDefinition/ch-lab-report-device-definition | Version: 0.1.1 | |||
| Active as of 2023-12-28 | Computable Name: ChLabReportDeviceDefinition | |||
Copyright/Legal: CC0-1.0 |
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Holds udiDeviceIdentifier from Test , regulatoryIdentifier,
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from DeviceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  DeviceDefinition | DeviceDefinition | |||
  udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
 manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |
 deviceName | ||||
  type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Required Pattern: 30234008 | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
  udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | 0..* | Identifier | Instance identifier | |||||
| udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |||||
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |||||
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |||||
| manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |||||
| deviceName | 0..* | BackboneElement | A name given to the device to identify it | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | 1..1 | string | The name of the device | |||||
| type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Required Pattern: 30234008 | |||||
| modelNumber | 0..1 | string | The model number for the device | |||||
| type | 0..1 | CodeableConcept | What kind of device or device system this is Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification. | |||||
| specialization | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| systemType | 1..1 | string | The standard that is used to operate and communicate | |||||
| version | 0..1 | string | The version of the standard that is used to operate and communicate | |||||
| version | 0..* | string | Available versions | |||||
| safety | Σ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) | ||||
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |||||
| physicalCharacteristics | 0..1 | ProdCharacteristic | Dimensions, color etc. | |||||
| languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |||||
| capability | 0..* | BackboneElement | Device capabilities | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | 1..1 | CodeableConcept | Type of capability | |||||
| description | 0..* | CodeableConcept | Description of capability | |||||
| property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity | 0..* | Quantity | Property value as a quantity | |||||
| valueCode | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| owner | 0..1 | Reference(Organization) | Organization responsible for device | |||||
| contact | 0..* | ContactPoint | Details for human/organization for support | |||||
| url | 0..1 | uri | Network address to contact device | |||||
| onlineInformation | 0..1 | uri | Access to on-line information | |||||
| note | 0..* | Annotation | Device notes and comments | |||||
| quantity | 0..1 | Quantity | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) | |||||
| parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of | ||||
| material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| substance | 1..1 | CodeableConcept | The substance | |||||
| alternate | 0..1 | boolean | Indicates an alternative material of the device | |||||
| allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| DeviceDefinition.language | preferred | CommonLanguages
| ||||
| DeviceDefinition.deviceName.type | required | Pattern: 30234008 | ||||
| DeviceDefinition.type | example | FHIRDeviceTypes | ||||
| DeviceDefinition.safety | example | DeviceSafety |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Differential View
This structure is derived from DeviceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | DeviceDefinition | |||
| udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
| manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |
| deviceName | ||||
| type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Required Pattern: 30234008 | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | 0..* | Identifier | Instance identifier | |||||
| udiDeviceIdentifier | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | |||||
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |||||
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |||||
| manufacturer[x] | 0..1 | Reference(CH Core Organization) | Name of device manufacturer | |||||
| deviceName | 0..* | BackboneElement | A name given to the device to identify it | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | 1..1 | string | The name of the device | |||||
| type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Required Pattern: 30234008 | |||||
| modelNumber | 0..1 | string | The model number for the device | |||||
| type | 0..1 | CodeableConcept | What kind of device or device system this is Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification. | |||||
| specialization | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| systemType | 1..1 | string | The standard that is used to operate and communicate | |||||
| version | 0..1 | string | The version of the standard that is used to operate and communicate | |||||
| version | 0..* | string | Available versions | |||||
| safety | Σ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) | ||||
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |||||
| physicalCharacteristics | 0..1 | ProdCharacteristic | Dimensions, color etc. | |||||
| languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |||||
| capability | 0..* | BackboneElement | Device capabilities | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | 1..1 | CodeableConcept | Type of capability | |||||
| description | 0..* | CodeableConcept | Description of capability | |||||
| property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity | 0..* | Quantity | Property value as a quantity | |||||
| valueCode | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| owner | 0..1 | Reference(Organization) | Organization responsible for device | |||||
| contact | 0..* | ContactPoint | Details for human/organization for support | |||||
| url | 0..1 | uri | Network address to contact device | |||||
| onlineInformation | 0..1 | uri | Access to on-line information | |||||
| note | 0..* | Annotation | Device notes and comments | |||||
| quantity | 0..1 | Quantity | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) | |||||
| parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of | ||||
| material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| substance | 1..1 | CodeableConcept | The substance | |||||
| alternate | 0..1 | boolean | Indicates an alternative material of the device | |||||
| allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| DeviceDefinition.language | preferred | CommonLanguages
| ||||
| DeviceDefinition.deviceName.type | required | Pattern: 30234008 | ||||
| DeviceDefinition.type | example | FHIRDeviceTypes | ||||
| DeviceDefinition.safety | example | DeviceSafety |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Other representations of profile: CSV, Excel, Schematron