This page is part of the 臺灣核心實作指引(TW Core IG) (v0.3.2: Releases) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
Official URL: https://twcore.mohw.gov.tw/ig/twcore/StructureDefinition/Device-twcore | Version: 0.3.2 | |||
Active as of 2024-12-12 | Computable Name: TWCoreImplantableDevice |
此臺灣核心-植入式裝置(TW Core Implantable Device) Profile說明本IG如何進一步定義FHIR的Device Resource以呈現植入式裝置資料。
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Device
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 | |
identifier | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
udiCarrier | S | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
deviceIdentifier | S | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
carrierHRF | S | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
manufacturer | S | 0..1 | string | 製造商 |
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD Example General: 2025-01-01 |
lotNumber | S | 0..1 | string | 批號 Example General: 250101 |
serialNumber | S | 0..1 | string | 序號 Example S1538501: S1538501 |
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 |
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device | |
location | 0..1 | Reference(TW Core Location) | Where the device is found | |
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device | |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
identifier | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) ele-1: All FHIR elements must have a @value or children |
udiCarrier | SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
deviceIdentifier | SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 ele-1: All FHIR elements must have a @value or children Example General: 08436569590324 |
carrierHRF | SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) ele-1: All FHIR elements must have a @value or children Example General: (01)08436569590324(17)250101(10)PT13254 |
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children |
manufacturer | S | 0..1 | string | 製造商 ele-1: All FHIR elements must have a @value or children |
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD ele-1: All FHIR elements must have a @value or children Example General: 2025-01-01 |
lotNumber | S | 0..1 | string | 批號 ele-1: All FHIR elements must have a @value or children Example General: 250101 |
serialNumber | S | 0..1 | string | 序號 ele-1: All FHIR elements must have a @value or children Example S1538501: S1538501 |
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. ele-1: All FHIR elements must have a @value or children |
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 ele-1: All FHIR elements must have a @value or children |
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device ele-1: All FHIR elements must have a @value or children | |
location | 0..1 | Reference(TW Core Location) | Where the device is found ele-1: All FHIR elements must have a @value or children | |
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device ele-1: All FHIR elements must have a @value or children | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | |
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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().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 | 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 | ||||
---|---|---|---|---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 | |||||
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 | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) | ||||
definition | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
udiCarrier | SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 | ||||
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 | SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 | ||||
issuer | 0..1 | uri | UDI Issuing Organization | |||||
jurisdiction | 0..1 | uri | Regional UDI authority | |||||
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
carrierHRF | SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 | ||||
entryType | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
statusReason | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
distinctIdentifier | 0..1 | string | The distinct identification string | |||||
manufacturer | S | 0..1 | string | 製造商 | ||||
manufactureDate | 0..1 | dateTime | Date when the device was made | |||||
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD Example General: 2025-01-01 | ||||
lotNumber | S | 0..1 | string | 批號 Example General: 250101 | ||||
serialNumber | S | 0..1 | string | 序號 Example S1538501: S1538501 | ||||
deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
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. | |||||
modelNumber | 0..1 | string | The model number for the device | |||||
partNumber | 0..1 | string | The part number of the device | |||||
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. | ||||
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 | CodeableConcept | 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..* | BackboneElement | The actual design of the device or software version running on the device | |||||
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 | 0..1 | CodeableConcept | The type of the device version | |||||
component | 0..1 | Identifier | A single component of the device version | |||||
value | 1..1 | string | The version text | |||||
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) | |||||
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 | ||||
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device | |||||
contact | 0..* | ContactPoint | Details for human/organization for support | |||||
location | 0..1 | Reference(TW Core Location) | Where the device is found | |||||
url | 0..1 | uri | Network address to contact device | |||||
note | 0..* | Annotation | Device notes and comments | |||||
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
Device.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard | ||||
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | ||||
Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard | ||||
Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard | ||||
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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().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 | 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() |
This structure is derived from Device
Summary
Mandatory: 1 element(1 nested mandatory element)
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Differential View
This structure is derived from Device
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 | |
identifier | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
udiCarrier | S | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
deviceIdentifier | S | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
carrierHRF | S | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
manufacturer | S | 0..1 | string | 製造商 |
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD Example General: 2025-01-01 |
lotNumber | S | 0..1 | string | 批號 Example General: 250101 |
serialNumber | S | 0..1 | string | 序號 Example S1538501: S1538501 |
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 |
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device | |
location | 0..1 | Reference(TW Core Location) | Where the device is found | |
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device | |
Documentation for this format |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
identifier | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) ele-1: All FHIR elements must have a @value or children |
udiCarrier | SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
deviceIdentifier | SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 ele-1: All FHIR elements must have a @value or children Example General: 08436569590324 |
carrierHRF | SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) ele-1: All FHIR elements must have a @value or children Example General: (01)08436569590324(17)250101(10)PT13254 |
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children |
manufacturer | S | 0..1 | string | 製造商 ele-1: All FHIR elements must have a @value or children |
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD ele-1: All FHIR elements must have a @value or children Example General: 2025-01-01 |
lotNumber | S | 0..1 | string | 批號 ele-1: All FHIR elements must have a @value or children Example General: 250101 |
serialNumber | S | 0..1 | string | 序號 ele-1: All FHIR elements must have a @value or children Example S1538501: S1538501 |
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. ele-1: All FHIR elements must have a @value or children |
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 ele-1: All FHIR elements must have a @value or children |
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device ele-1: All FHIR elements must have a @value or children | |
location | 0..1 | Reference(TW Core Location) | Where the device is found ele-1: All FHIR elements must have a @value or children | |
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device ele-1: All FHIR elements must have a @value or children | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | |
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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().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 | 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() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Device | 0..* | Device | 植入式醫療器材 | |||||
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 | S | 0..* | Identifier | 植入式醫療器材識別代碼,可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) | ||||
definition | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
udiCarrier | SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示,詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 | ||||
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 | SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 | ||||
issuer | 0..1 | uri | UDI Issuing Organization | |||||
jurisdiction | 0..1 | uri | Regional UDI authority | |||||
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
carrierHRF | SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 | ||||
entryType | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
statusReason | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
distinctIdentifier | 0..1 | string | The distinct identification string | |||||
manufacturer | S | 0..1 | string | 製造商 | ||||
manufactureDate | 0..1 | dateTime | Date when the device was made | |||||
expirationDate | S | 0..1 | dateTime | 有效期限。格式:YYYY-MM-DD Example General: 2025-01-01 | ||||
lotNumber | S | 0..1 | string | 批號 Example General: 250101 | ||||
serialNumber | S | 0..1 | string | 序號 Example S1538501: S1538501 | ||||
deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
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. | |||||
modelNumber | 0..1 | string | The model number for the device | |||||
partNumber | 0..1 | string | The part number of the device | |||||
type | S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. | ||||
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 | CodeableConcept | 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..* | BackboneElement | The actual design of the device or software version running on the device | |||||
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 | 0..1 | CodeableConcept | The type of the device version | |||||
component | 0..1 | Identifier | A single component of the device version | |||||
value | 1..1 | string | The version text | |||||
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) | |||||
patient | S | 1..1 | Reference(TW Core Patient) | 病人資訊 | ||||
owner | 0..1 | Reference(TW Core Organization) | Organization responsible for device | |||||
contact | 0..* | ContactPoint | Details for human/organization for support | |||||
location | 0..1 | Reference(TW Core Location) | Where the device is found | |||||
url | 0..1 | uri | Network address to contact device | |||||
note | 0..* | Annotation | Device notes and comments | |||||
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
parent | 0..1 | Reference(TW Core Implantable Device) | The parent device | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
Device.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard | ||||
Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard | ||||
Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard | ||||
Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard | ||||
Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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().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 | 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() |
This structure is derived from Device
Summary
Mandatory: 1 element(1 nested mandatory element)
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
以下概述了此Profile所需的RESTful FHIR互動功能。有關TW Core IG支援的RESTful互動功能的完整清單,請參閱TW Core Server能力聲明。
必須(SHALL) 支援透過查詢參數 patient
查詢所有Device:
(如何透過reference查詢)
GET [base]/Device?patient={Type/}[id]
例子:
(1) GET [base]/Device?patient=Patient/pat-example
建議應該(SHOULD) 支援透過查詢參數 patient
及 type
查詢所有Device:
(如何透過reference查詢)
(如何透過token查詢)
GET [base]/Device?patient={Type/}[id]&type={system|}[code]
例子:
(1) GET [base]/Device?patient=Patient/pat-example&type=http://snomed.info/sct|468063009
建議應該(SHOULD) 支援透過查詢參數 patient
及 status
查詢所有Device:
(如何透過reference查詢)
(如何透過token查詢)
GET [base]/Device?patient={Type/}[id]&status=[code]
例子:
(1) GET [base]/Device?patient=Patient/pat-example&status=active