HL7 Vietnam VN Core FHIR Implementation Guide

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam
0.5.0 - Draft for Community Review Viet Nam cờ

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam - Draft for Community Review (v0.5.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Hồ sơ tài nguyên: Thiết bị y tế VN Core — VN Core Device Profile

URL chính thức: http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-device Phiên bản: 0.5.0
Computable Name: VNCoreDevice

Bản quyền/Pháp lý: Căn cứ pháp lý Việt Nam: VBHN 08/2026/VBHN-BYT (01/2026) hợp nhất NĐ 98/2021/NĐ-CP ngày 08/11/2021 + NĐ 07/2023/NĐ-CP ngày 03/03/2023 + NĐ 04/2025/NĐ-CP hiệu lực 01/01/2025 (bao gồm phân biệt TBYT thông thường và TBYT IVD); VBHN 04/2026/VBHN-BYT (01/2026) hợp nhất TT 05/2022/TT-BYT ngày 01/03/2022 + TT 59/2025/TT-BYT; TT 04/2017/TT-BYT ngày 14/04/2017, Phụ lục 01; TT 24/2025/TT-BYT ngày 30/06/2025, hiệu lực 01/09/2025; VBHN 14/VBHN-BYT năm 2025 hợp nhất TT 04/2017/TT-BYT + TT 24/2025/TT-BYT; QĐ 3176/QĐ-BYT ngày 29/10/2024; QĐ 5086/QĐ-BYT, QĐ 637/QĐ-BYT (2022), QĐ 1844/QĐ-BYT (2022), QĐ 3181/QĐ-BYT (2022); QĐ 3107/QĐ-BYT (2024); QĐ 847/QĐ-BYT (2025).

Profile Device cho thiết bị y tế (TBYT), bao gồm vật tư tiêu hao, thiết bị dùng trong chăm sóc và thiết bị cấy ghép tại Việt Nam. Giữ định danh thiết bị/vật tư (MA_VAT_TU khi legacy cần trao đổi như identifier), UDI, thông tin nhận dạng và vòng đời thiết bị. Thông tin thanh toán BHYT theo từng dòng chi phí như nhóm TBYT, phạm vi, tỷ lệ thanh toán và mức hưởng phải ưu tiên đặt tại Claim.item; Device chỉ giữ dữ liệu thiết bị hoặc fallback legacy khi chưa có Claim. Liên kết với Claim.item (chi phí TBYT) và DeviceUseStatement (ghi nhận sử dụng lâm sàng). Căn cứ pháp lý Việt Nam:

  • VBHN 08/2026/VBHN-BYT (01/2026) — Văn bản hợp nhất chính thức NĐ 98/2021/NĐ-CP (08/11/2021) + NĐ 07/2023/NĐ-CP (03/03/2023) + NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025) về quản lý thiết bị y tế (bao gồm phân biệt TBYT thông thường và TBYT IVD chẩn đoán in vitro)
  • VBHN 04/2026/VBHN-BYT (01/2026) — Văn bản hợp nhất TT 05/2022/TT-BYT (01/03/2022) + TT 59/2025/TT-BYT về phân loại TBYT và kiểm định
  • TT 04/2017/TT-BYT (14/4/2017) Phụ lục 01 — 9 nhóm TBYT BHYT
  • TT 24/2025/TT-BYT (30/6/2025, hiệu lực 01/9/2025) — sửa đổi TT 04/2017/TT-BYT, thống nhất thuật ngữ VTYT → TBYT
  • VBHN 14/VBHN-BYT năm 2025 hợp nhất TT 04/2017/TT-BYT + TT 24/2025/TT-BYT: https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Van-ban-hop-nhat-14-VBHN-BYT-2025-Thong-tu-dieu-kien-thanh-toan-doi-voi-vat-tu-y-te-thuoc-bao-hiem-y-te-670262.aspx
  • QĐ 3176/QĐ-BYT — trường MA_VAT_TU trong XML dữ liệu đầu ra KCB
  • QĐ 5086/QĐ-BYT, QĐ 637/QĐ-BYT (2022), QĐ 1844/QĐ-BYT (2022), QĐ 3181/QĐ-BYT (2022) — mã hãng sản xuất VTYT/TBYT, không phải danh mục mã hàng đầy đủ
  • QĐ 3107/QĐ-BYT (2024) và QĐ 847/QĐ-BYT (2025) — danh pháp TBYT, package hl7.fhir.vn.device tách riêng, dùng tham chiếu tùy chọn khi cần chuẩn hóa tên gọi. Ghi chú:
  • UDI carrier là best practice quốc tế của HL7/FHIR, không được trình bày như căn cứ bắt buộc trong pháp luật Việt Nam.
  • Phân loại rủi ro A/B/C/D theo VBHN 08/2026/VBHN-BYT (hợp nhất NĐ 98/2021 + NĐ 07/2023 + NĐ 04/2025) được hỗ trợ bằng extension tùy chọn, không bắt buộc cho mọi Device.
  • Cờ IVD (vn-ext-device-ivd) phân biệt TBYT chẩn đoán in vitro với TBYT thông thường theo VBHN 08/2026/VBHN-BYT, là dimension regulatory tùy chọn ở mức sản phẩm/model.
  • TT 57/2025/TT-BYT (31/12/2025, hiệu lực 15/02/2026, triển khai 01/01/2027) phân nhóm TBYT theo tiêu chuẩn kỹ thuật/chất lượng phục vụ đấu thầu (căn cứ NĐ 214/2025/NĐ-CP về Luật Đấu thầu) là dimension procurement độc lập, không thuộc VN Core; nếu cần, dùng package hl7.fhir.vn.procurement riêng.

Usages:

You can also check for usages in the FHIR IG Statistics

Các dạng xem hình thức của nội dung hồ sơ

Mô tả profile, differential, snapshot và các biểu diễn liên quan.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
... udiCarrier SΣ 0..* BackboneElement UDI carrier
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... carrierHRF SΣ 0..1 string UDI human-readable form
... status ?!SΣ 1..1 code Trạng thái: active | inactive
Binding: FHIRDeviceStatus (required): The availability status of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / Quy cách
... type S 0..1 CodeableConcept Loại TBYT
Binding: DeviceType (example): Codes to identify medical devices.
... patient S 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... type
...... text 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value S 1..1 string Giá trị MA_VAT_TU
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... type 0..1 CodeableConcept Description of identifier
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
..... system 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value S 1..1 string Số serial
... udiCarrier S 0..* BackboneElement UDI carrier
.... deviceIdentifier S 0..1 string UDI Device Identifier
.... carrierHRF S 0..1 string UDI human-readable form
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / Quy cách
... type S 0..1 CodeableConcept Loại TBYT
... patient S 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... 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.
Additional BindingsPurpose
AllLanguages Max Binding
... text 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
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 0..* BackboneElement UDI carrier
.... 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 0..1 string UDI Device Identifier
.... 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 UDI human-readable form
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Trạng thái: active | inactive
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 S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... 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 S 0..1 string Model / Quy cách
... partNumber 0..1 string The part number of the device
... type S 0..1 CodeableConcept Loại TBYT
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 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

Summary

Mandatory: 1 element(4 nested mandatory elements)
Must-Support: 18 elements
Fixed: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the values of Device.identifier

Dạng xem phần tử chính

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
... udiCarrier SΣ 0..* BackboneElement UDI carrier
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... carrierHRF SΣ 0..1 string UDI human-readable form
... status ?!SΣ 1..1 code Trạng thái: active | inactive
Binding: FHIRDeviceStatus (required): The availability status of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / Quy cách
... type S 0..1 CodeableConcept Loại TBYT
Binding: DeviceType (example): Codes to identify medical devices.
... patient S 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

Dạng xem Differential

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... type
...... text 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value S 1..1 string Giá trị MA_VAT_TU
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... type 0..1 CodeableConcept Description of identifier
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
..... system 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value S 1..1 string Số serial
... udiCarrier S 0..* BackboneElement UDI carrier
.... deviceIdentifier S 0..1 string UDI Device Identifier
.... carrierHRF S 0..1 string UDI human-readable form
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / Quy cách
... type S 0..1 CodeableConcept Loại TBYT
... patient S 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)

doco Documentation for this format

Dạng xem SnapshotView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... 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.
Additional BindingsPurpose
AllLanguages Max Binding
... text 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
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass 0..1 CodeableConcept Phân loại rủi ro TBYT A/B/C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber 0..1 Identifier Số lưu hành TBYT (VBHN 08/2026)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 0..* BackboneElement UDI carrier
.... 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 0..1 string UDI Device Identifier
.... 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 UDI human-readable form
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Trạng thái: active | inactive
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 S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... 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 S 0..1 string Model / Quy cách
... partNumber 0..1 string The part number of the device
... type S 0..1 CodeableConcept Loại TBYT
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 0..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã sử dụng thiết bị
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

Summary

Mandatory: 1 element(4 nested mandatory elements)
Must-Support: 18 elements
Fixed: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the values of Device.identifier

 

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