CardX - Cardiac Implantable Electronic Devices, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CardX-CIED/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/cardx-cied/StructureDefinition/cied-device | Version: 1.0.0 | |||
| Standards status: Trial-use Active as of 2025-12-15 | Maturity Level: 2 | Computable Name: CIEDDevice | ||
The CardX CIED Device profile is interoperable with ISO/IEEE 11073-10103 - Implantable device, cardiac. The cardinality of the profile aligns with the optionality of the ISO/IEEE 11073/10103 terms.
The following data-elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). Within IEEE 11073-10103, MDC_IDC_DEV contains the following data elements: MDC_IDC_DEV_TYPE, MDC_IDC_DEV_MODEL, MDC_IDC_DEV_SERIAL, MDC_IDC_DEV_MFG
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
C | 0..* | Device | Item used in healthcare Constraints: dev-1 |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
SΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
Σ | 1..1 | string | Mandatory fixed portion of UDI |
![]() ![]() ![]() |
Σ | 1..1 | uri | UDI Issuing Organization |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device. |
![]() ![]() |
S | 1..1 | string | Name of device manufacturer |
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer |
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device |
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. |
![]() ![]() ![]() |
Σ | 0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIR Device Status | 📍5.0.0 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍5.0.0 | FHIR Std. |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| dev-1 | error | Device | only one Device.name.display SHALL be true when there is more than one Device.name |
name.where(display=true).count() <= 1
|
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Device | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Device | 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 | Device | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Device | 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 Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
![]() ![]() |
S | 1..1 | string | Name of device manufacturer |
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer |
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device |
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device |
![]() ![]() ![]() |
0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) | |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
C | 0..* | Device | Item used in healthcare Constraints: dev-1 | ||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
0..* | Identifier | Instance identifier | |||||
![]() ![]() |
0..1 | string | The name used to display by default when the device is referenced | |||||
![]() ![]() |
0..1 | CodeableReference(DeviceDefinition) | The reference to the definition for the device | |||||
![]() ![]() |
SΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
Σ | 1..1 | string | Mandatory fixed portion of UDI | ||||
![]() ![]() ![]() |
Σ | 1..1 | uri | UDI Issuing Organization | ||||
![]() ![]() ![]() |
0..1 | uri | Regional UDI authority | |||||
![]() ![]() ![]() |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
![]() ![]() ![]() |
Σ | 0..1 | string | UDI Human Readable Barcode String | ||||
![]() ![]() ![]() |
0..1 | code | barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device. | ||||
![]() ![]() |
0..1 | CodeableConcept | lost | damaged | destroyed | available Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device. | |||||
![]() ![]() |
0..1 | Identifier | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled | |||||
![]() ![]() |
S | 1..1 | string | Name of device manufacturer | ||||
![]() ![]() |
0..1 | dateTime | Date when the device was made | |||||
![]() ![]() |
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||
![]() ![]() |
0..1 | string | Lot number of manufacture | |||||
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer | ||||
![]() ![]() |
C | 0..* | BackboneElement | The name or names of the device as known to the manufacturer and/or patient | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
Σ | 1..1 | string | The term that names the device | ||||
![]() ![]() ![]() |
Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. | ||||
![]() ![]() ![]() |
?!ΣC | 0..1 | boolean | The preferred device name | ||||
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device | ||||
![]() ![]() |
0..1 | string | The part number or catalog number of the device | |||||
![]() ![]() |
0..* | CodeableConcept | Indicates a high-level grouping of the device Binding: FHIRDeviceCategory (example): Categories of medical devices. | |||||
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. | ||||
![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() |
Σ | 0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) | ||||
![]() ![]() ![]() |
Σ | 0..1 | string | Plain text representation of the concept | ||||
![]() ![]() |
0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal Binding: DeviceVersionType (example): The type of version indicated for the device. | |||||
![]() ![]() ![]() |
0..1 | Identifier | The hardware or software module of the device to which the version applies | |||||
![]() ![]() ![]() |
0..1 | dateTime | The date the version was installed on the device | |||||
![]() ![]() ![]() |
1..1 | string | The version text | |||||
![]() ![]() |
0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: DeviceSpecificationCategory (example): The kind of standards used by the device. | |||||
![]() ![]() ![]() |
1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to Binding: DeviceSpecificationType (example): The type of version indicated for the device. | |||||
![]() ![]() ![]() |
0..1 | string | Specific form or variant of the standard | |||||
![]() ![]() |
0..* | BackboneElement | Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |||||
![]() ![]() ![]() |
1..1 | Value of the property | ||||||
![]() ![]() ![]() ![]() |
Quantity | |||||||
![]() ![]() ![]() ![]() |
CodeableConcept | |||||||
![]() ![]() ![]() ![]() |
string | |||||||
![]() ![]() ![]() ![]() |
boolean | |||||||
![]() ![]() ![]() ![]() |
integer | |||||||
![]() ![]() ![]() ![]() |
Range | |||||||
![]() ![]() ![]() ![]() |
Attachment | |||||||
![]() ![]() |
0..1 | CodeableConcept | The designated condition for performing a task Binding: FHIRDeviceOperationMode (example): Operational mode of a device. | |||||
![]() ![]() |
0..1 | Count | The series of occurrences that repeats during the operation of the device | |||||
![]() ![]() |
0..1 | Duration | A measurement of time during the device's operation (e.g., days, hours, mins, etc.) | |||||
![]() ![]() |
0..1 | Reference(Organization) | Organization responsible for device | |||||
![]() ![]() |
0..* | ContactPoint | Details for human/organization for support | |||||
![]() ![]() |
0..1 | Reference(Location) | Where the device is found | |||||
![]() ![]() |
0..1 | uri | Network address to contact device | |||||
![]() ![]() |
0..* | Reference(Endpoint) | Technical endpoints providing access to electronic services provided by the device | |||||
![]() ![]() |
0..* | CodeableReference(Device) | Linked device acting as a communication/data collector, translator or controller | |||||
![]() ![]() |
0..* | Annotation | Device notes and comments | |||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device Binding: DeviceSafety (example) | ||||
![]() ![]() |
0..1 | Reference(Device) | The higher level or encompassing device that this device is a logical part of | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDI Entry Type | 📍5.0.0 | FHIR Std. |
| Device.status | Base | required | FHIR Device Status | 📍5.0.0 | FHIR Std. |
| Device.availabilityStatus | Base | extensible | FHIR Device Availability Status | 📍5.0.0 | FHIR Std. |
| Device.name.type | Base | required | Device Name Type | 📍5.0.0 | FHIR Std. |
| Device.category | Base | example | FHIR Device Category | 📍5.0.0 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍5.0.0 | FHIR Std. |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
| Device.version.type | Base | example | Device Version Type | 📍5.0.0 | FHIR Std. |
| Device.conformsTo.category | Base | example | Device Specification Category | 📍5.0.0 | FHIR Std. |
| Device.conformsTo.specification | Base | example | Device Specification Type | 📍5.0.0 | FHIR Std. |
| Device.property.type | Base | example | Device Property Type | 📍5.0.0 | FHIR Std. |
| Device.mode | Base | example | FHIR Device Operation Mode | 📍5.0.0 | FHIR Std. |
| Device.safety | Base | example | Device Safety | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dev-1 | error | Device | only one Device.name.display SHALL be true when there is more than one Device.name |
name.where(display=true).count() <= 1
|
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Device | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Device | 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 | Device | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Device | 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()
|
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
C | 0..* | Device | Item used in healthcare Constraints: dev-1 |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
0..* | Resource | Contained, inline Resources | |
![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
SΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
Σ | 1..1 | string | Mandatory fixed portion of UDI |
![]() ![]() ![]() |
Σ | 1..1 | uri | UDI Issuing Organization |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device. |
![]() ![]() |
S | 1..1 | string | Name of device manufacturer |
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer |
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device |
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. |
![]() ![]() ![]() |
Σ | 0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIR Device Status | 📍5.0.0 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍5.0.0 | FHIR Std. |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| dev-1 | error | Device | only one Device.name.display SHALL be true when there is more than one Device.name |
name.where(display=true).count() <= 1
|
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Device | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Device | 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 | Device | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Device | 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()
|
Differential View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | Device | Item used in healthcare | |
![]() ![]() |
S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
![]() ![]() |
S | 1..1 | string | Name of device manufacturer |
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer |
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device |
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device |
![]() ![]() ![]() |
0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) | |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
C | 0..* | Device | Item used in healthcare Constraints: dev-1 | ||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
0..* | Identifier | Instance identifier | |||||
![]() ![]() |
0..1 | string | The name used to display by default when the device is referenced | |||||
![]() ![]() |
0..1 | CodeableReference(DeviceDefinition) | The reference to the definition for the device | |||||
![]() ![]() |
SΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
Σ | 1..1 | string | Mandatory fixed portion of UDI | ||||
![]() ![]() ![]() |
Σ | 1..1 | uri | UDI Issuing Organization | ||||
![]() ![]() ![]() |
0..1 | uri | Regional UDI authority | |||||
![]() ![]() ![]() |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
![]() ![]() ![]() |
Σ | 0..1 | string | UDI Human Readable Barcode String | ||||
![]() ![]() ![]() |
0..1 | code | barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device. | ||||
![]() ![]() |
0..1 | CodeableConcept | lost | damaged | destroyed | available Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device. | |||||
![]() ![]() |
0..1 | Identifier | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled | |||||
![]() ![]() |
S | 1..1 | string | Name of device manufacturer | ||||
![]() ![]() |
0..1 | dateTime | Date when the device was made | |||||
![]() ![]() |
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||
![]() ![]() |
0..1 | string | Lot number of manufacture | |||||
![]() ![]() |
S | 1..1 | string | Serial number assigned by the manufacturer | ||||
![]() ![]() |
C | 0..* | BackboneElement | The name or names of the device as known to the manufacturer and/or patient | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
![]() ![]() ![]() |
Σ | 1..1 | string | The term that names the device | ||||
![]() ![]() ![]() |
Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. | ||||
![]() ![]() ![]() |
?!ΣC | 0..1 | boolean | The preferred device name | ||||
![]() ![]() |
S | 1..1 | string | The manufacturer's model number for the device | ||||
![]() ![]() |
0..1 | string | The part number or catalog number of the device | |||||
![]() ![]() |
0..* | CodeableConcept | Indicates a high-level grouping of the device Binding: FHIRDeviceCategory (example): Categories of medical devices. | |||||
![]() ![]() |
S | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: MDC IDC Device Types (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal Binding: DeviceVersionType (example): The type of version indicated for the device. | |||||
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0..1 | Identifier | The hardware or software module of the device to which the version applies | |||||
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0..1 | dateTime | The date the version was installed on the device | |||||
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1..1 | string | The version text | |||||
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0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: DeviceSpecificationCategory (example): The kind of standards used by the device. | |||||
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1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to Binding: DeviceSpecificationType (example): The type of version indicated for the device. | |||||
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0..1 | string | Specific form or variant of the standard | |||||
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0..* | BackboneElement | Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |||||
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1..1 | Value of the property | ||||||
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Quantity | |||||||
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CodeableConcept | |||||||
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string | |||||||
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boolean | |||||||
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integer | |||||||
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Range | |||||||
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Attachment | |||||||
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0..1 | CodeableConcept | The designated condition for performing a task Binding: FHIRDeviceOperationMode (example): Operational mode of a device. | |||||
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0..1 | Count | The series of occurrences that repeats during the operation of the device | |||||
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0..1 | Duration | A measurement of time during the device's operation (e.g., days, hours, mins, etc.) | |||||
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0..1 | Reference(Organization) | Organization responsible for device | |||||
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0..* | ContactPoint | Details for human/organization for support | |||||
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0..1 | Reference(Location) | Where the device is found | |||||
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0..1 | uri | Network address to contact device | |||||
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0..* | Reference(Endpoint) | Technical endpoints providing access to electronic services provided by the device | |||||
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0..* | CodeableReference(Device) | Linked device acting as a communication/data collector, translator or controller | |||||
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0..* | Annotation | Device notes and comments | |||||
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Σ | 0..* | CodeableConcept | Safety Characteristics of Device Binding: DeviceSafety (example) | ||||
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0..1 | Reference(Device) | The higher level or encompassing device that this device is a logical part of | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDI Entry Type | 📍5.0.0 | FHIR Std. |
| Device.status | Base | required | FHIR Device Status | 📍5.0.0 | FHIR Std. |
| Device.availabilityStatus | Base | extensible | FHIR Device Availability Status | 📍5.0.0 | FHIR Std. |
| Device.name.type | Base | required | Device Name Type | 📍5.0.0 | FHIR Std. |
| Device.category | Base | example | FHIR Device Category | 📍5.0.0 | FHIR Std. |
| Device.type | Base | example | Device Type | 📍5.0.0 | FHIR Std. |
| Device.type.coding | Base | required | MDC IDC Device Types | 📦1.0.0 | This IG |
| Device.version.type | Base | example | Device Version Type | 📍5.0.0 | FHIR Std. |
| Device.conformsTo.category | Base | example | Device Specification Category | 📍5.0.0 | FHIR Std. |
| Device.conformsTo.specification | Base | example | Device Specification Type | 📍5.0.0 | FHIR Std. |
| Device.property.type | Base | example | Device Property Type | 📍5.0.0 | FHIR Std. |
| Device.mode | Base | example | FHIR Device Operation Mode | 📍5.0.0 | FHIR Std. |
| Device.safety | Base | example | Device Safety | 📍5.0.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dev-1 | error | Device | only one Device.name.display SHALL be true when there is more than one Device.name |
name.where(display=true).count() <= 1
|
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Device | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Device | 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 | Device | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Device | 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()
|
Other representations of profile: CSV, Excel, Schematron