Device
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A manufactured instrument, apparatus, machine, software, implant or similar item that is intended for use in the monitoring, diagnosis, prevention, mitigation or alleviation of a health condition or injury.
Note: this includes non-medical devices (e.g., a cane, cell phone).
The organization that manufactures non-medical devices is generally not a Health Care Product Manufacturing Organization (such organizations manufacture only medical devices).
Diagrammes connexes
Contraintes
s. o.
Stéréotypes
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Attributs
| Attribut | Type | Multiplicité | Note sur l’attribut |
|---|---|---|---|
| Device Instance Identifier | Identifier | 0..* | Unique business instance identifier(s) assigned to a device by manufacturers, other organizations, or owners. |
| Device Type Code | Codeable Concept | 0..* | Uniquely specifies the kind(s) or type(s) of device. A device instance may have more than one type, in which case these are the types that apply to the specific instance of the device.
Examples: blood pressure cuff, electro-cardiograph, weight scale, dental implant, dual-chamber implantable pacemaker.
Value Set: To be developed. |
| Device Category Code | Codeable Concept | 0..* | Uniquely specifies the high-level grouping of the device.
Examples: Implantable, Home use, Point of care.
Value Set:
https://hl7.org/fhir/R5/valueset-device-category.html |
| Device Manufacture Date | Date | 0..1 | The date the device was manufactured. |
| Device Expiration Date Time | Date Time | 0..1 | The date and (if known) time beyond which this device is no longer valid or should not be used. |
| Device Lot Number | String | 0..1 | Device lot number assigned by the manufacturer. |
| Device Serial Number | String | 0..1 | Serial number assigned by the manufacturer. |
| Device Model Number | String | 0..1 | The manufacturer's model number for the device. |
| Device Part Number | String | 0..1 | The part number or catalog number of the device. |
| Device Status Code | Codeable Concept | 1 | Uniquely specifies the current operational status of the device (e.g., a pacemaker implanted in a patient may be active; a hip implant that was surgically removed is inactive).
Examples: active, inactive, entered-in-error, unknown.
Value Set:
https://hl7.org/fhir/R4B/valueset-device-status.html |
| Device Status Reason Code | Codeable Concept | 0..1 | Uniquely specifies the reason for the current device status (e.g., removed, unavailable).
Value Set:
https://hl7.org/fhir/R4B/valueset-device-status-reason.html |
| Device Availability Status Code | Codeable Concept | 0..1 | Uniquely specifies the device availability status.
Examples: lost, damaged, destroyed, available
Value Set:
https://hl7.org/fhir/R5/valueset-device-availability-status.html |
| Device Safety Feature Code | Codeable Concept | 0..* | Uniquely specifies the constraints, risks, and limitations of the device.
Examples: Magnetic Resonance Safe, Magnetic Resonance Unsafe, Labeled as Containing Natural Rubber Latex
Value Set: To be developed. |
Relations
| Classe d’origine | Multiplicité d’origine | Relation | Classe de destination | Multiplicité de destination |
|---|---|---|---|---|
| Device | 1 | has | Device Name | 1..* |
| Device | 0..1 | has | Document Reference | 0..* |
| Device | 0..1 | subject of | Observation | 0..* |
| Artificial Intelligence | is a | Device | ||
| Device | 1 | has | Regulatory Device UDI | 0..* |
| Health Care Service Party Role Location | 0..* | has | Device | 0..* |
| Device | is a | Party | ||
| Observation Data Absent Reason | 0..* | for | Device | 0..1 |
| Device | 0..* | at | Location | 0..1 |
| Device | 0..1 | has (composition) | Clinical Annotation | 0..* |
| Device | 1 | has | Device Usage | 0..* |
| Device | 0..1 | has (composition) | Device | 0..* |
| Device | 0..1 | subject of | Service Request | 0..* |
| Device | 0..1 | has | Contact Mechanism | 0..* |
| Observation | 0..* | generated by | Device | 0..1 |
| Device | 0..* | manufactured by | Organization | 0..1 |
| Device | 0..* | owned by | Health Care Organization | 0..1 |
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Comment citer ce contenu:
Institut canadien d’information sur la santé. Device. Consulté le 02 novembre 2026.
