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 |
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