Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of the People’s Republic of China (NMPA).
This standard is under the jurisdiction of the NMPA, Center for Medical Devices Standardization Administration.
Fundamental requirements for unique
device identifier
1 Scope
This standard specifies the terms and definitions, basic principles, device identifier requirements and production identifier requirements for unique device identifier.
This standard is applicable to the management of unique device identifier.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1988 Information technology — 7-bit Coded character set for information interchange
YY/T 0287 Medical devices — Quality management systems — Requirements for regulatory purposes
3 Terms and definitions
For the purposes of this standard, the terms and definitions given in YY/T 0287 and the followings apply.
3.1
unique device identifier
a series of codes consisting of numbers, letters and/or symbols created based on standards for uniquely identifying medical devices, including device identifier and production identifier
Note 1: The word "unique" does not indicate serialization management to a single product.
Note 2: It may be used for the management and traceability of medical device products.
Note 3: UDI is now used internationally to indicate “unique device identifier”.
3.2
device identifier
unique code specific to a certain specification, model and packaged medical device
Note 1: The device identifier may be used as the "access key" for the information stored in the unique identifier database of medical devices, which is associated with the product information, manufacturer information and registration information of medical devices.
Note 2: UDI-DI is now used internationally to indicate “device identifier”.
3.3
production identifier
code for identifying data in the medical device production process
Note 1: According to the actual application requirements, the production identifier may include the serial number, production batch number, production date and expiration date of medical devices.
Note 2: UDI-PI is now used internationally to indicate “production identifier”.
3.4
data delimiter
characters or character sets that define specific data elements in the unique device identifier
Note: Examples of data delimiter are application identifier (AD), object identifier (OID), etc.
4 Basic principles of unique device identifier
Basic principles of unique device identifier are:
a) The characters used shall conform to GB/T 1988 or relevant international standards;
Note: An example of such relevant international standards is ISO/IEC 646.
b) The unique device identifier shall be unique at the level of specifications, models, batches or individual products of medical devices. For medical devices with same characteristics, the uniqueness of the unique device identifier shall refer to a single specification and model product. For medical devices controlled by batch production, the uniqueness of the unique device identifier shall refer to the same batch of products. For medical devices controlled by serial number production, the uniqueness of the unique device identifier shall refer to a single product. This may be achieved by complying with international standards, such as ISO/IEC 15459-4 and ISO/IEC 15459-6, or by other appropriate means;
c) According to the specific using conditions, there shall be a corresponding verification mechanism, which is obtained by the standard algorithm, to verify the correctness of the whole or component of the unique device identifier;
d) The unique device identifier shall be as short as possible;
e) Data delimiter shall be included to ensure that all components of device identifier and production identifier can be correctly read and interpreted.
See Annex A for the structural schematic diagram of the unique device identifier.
5 Device identifier requirements
Specific requirements for device identifier are as follows:
a) It shall be able to identify the information of medical device manufacturers and the devices;
b) It shall be unique on all levels of device packaging (see Annex B).
6 Production identifier requirements
Production identification shall be used in combination with device identification, and its composition shall be determined according to device identification requirements;
a) If the medical device batch needs to be identified, the production batch number shall be included;
b) If the individual products of medical devices need to be identified, the serial number shall be included;
c) if the production date of medical devices needs to be identified, the production date shall be included;
d) If the expiration date of medical devices needs to be identified, the expiration date shall be included.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Basic principles of unique device identifier
5 Device identifier requirements
6 Production identifier requirements
Annex A (Informative) Structural schematic diagram of the unique device identifier
Annex B (Informative) Packaging schematic of device identifier and medical device
Bibliography
ICS 11.040.01；35.040
C 30
YY
中華人民共和國醫藥行業標準
YY/T 1630—2018
醫療器械唯一標識基本要求
Fundamental requirements for unique device identifier
2018-12-20發布 2020-01-01實施
國家藥品監督管理局 發布
前言
本標準按照GB/T 1.1—2009給出的規則起草。
請注意本文件的某些內容可能涉及專利。本文件的發布機構不承擔識別這些專利的責任。
本標準由國家藥品監督管理局提出。
本標準由原國家食品藥品監督管理總局醫療器械標準管理中心歸口。
醫療器械唯一標識基本要求
1 范圍
本標準規定了醫療器械唯一標識的相關術語和定義、基本原則、產品標識的要求和生產標識的要求。
本標準適用于醫療器械唯一標識的管理。
2 規范性引用文件
下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改單）適用于本文件。
GB/T 1988 信息技術 信息交換用七位編碼字符集
YY/T 0287 醫療器械 質量管理體系 用于法規的要求
3 術語和定義
YY/T 0287界定的以及下列術語和定義適用于本文件。
3.1
醫療器械唯一標識 unique device identifier
基于標準創建的一系列由數字、字母和/或符號組成的代碼，包括產品標識和生產標識，用于對醫療器械進行唯一性識別。
注1：“唯一”一詞并不意味著對單個產品進行序列化管理。
注2：可用于醫療器械產品的管理和追溯等。
注3：目前國際上通常使用UDI表示unique device identifier.
3.2
產品標識 device identifier
特定于某種規格型號和包裝醫療器械的唯一性代碼。
注1：產品標識可用作對醫療器械唯一標識數據庫存儲信息的“訪問關鍵字”，關聯醫療器械產品信息、制造商信息、注冊信息等。
注2：目前國際上通常使用UDI-DI表示device identifier。
3.3
生產標識 production identifier
識別醫療器械生產過程相關數據的代碼。
注1：根據實際應用需求，生產標識可包含醫療器械序列號、生產批號、生產日期、失效日期等。
注2：目前國際上通常使用UDI-PI表示production identifier。
3.4
數據分隔符 data delimiter
在醫療器械唯一標識中，定義特定數據元素的字符或字符集。
注：數據分隔符示例為應用標識符（AD）、對象標識符（OID）等。
4 醫療器械唯一標識的基本原則
醫療器械唯一標識的基本原則是：
a） 使用字符應符合GB/T 1988或相關國際標準；
注：相關國際標準如ISO/IEC 646。
b） 醫療器械唯一標識應能在醫療器械規格型號、批次或單個產品層次保持唯一。對于相同特征的醫療器械，醫療器械唯一標識的唯一性應指向單個規格型號產品；對于按照批次生產控制的醫療器械，醫療器械唯一標識的唯一性應指向同批次產品；對于采用序列號生產控制的醫療器械，醫療器械唯一標識的唯一性應指向單個產品。可通過符合國際標準，如ISO/IEC 15459-4和ISO/IEC 15459-6，或者通過其他適當的方式實現；
c） 應根據具體使用情況有相應的校驗機制，由標準的算法得出，以校驗醫療器械唯一標識整體或組成部分的正誤；
d） 醫療器械唯一標識的長度應盡可能簡短；
e） 應包括數據分隔符，保證產品標識和生產標識的各組成部分能夠正確識讀和解析。
醫療器械唯一標識的結構示意圖參見附錄A。
5 產品標識的要求
產品標識的具體要求是：
a） 應識別醫療器械制造商、產品信息；
b） 應在各級別的器械包裝上保持唯一（參見附錄B）。
6 生產標識的要求
生產標識應與產品標識聯合使用，其組成應根據產品的識別要求確定；
a） 對于需要識別醫療器械批次的，應包括生產批號；
b） 對于需要識別醫療器械單個產品的，應包括序列號；
c） 對于需要識別醫療器械生產日期的，應包括生產日期；
d） 對于需要識別醫療器械失效日期的，應包括失效日期。
附錄A
（資料性附錄）
醫療器械唯一標識結構示意圖
醫療器械唯一標識結構示意圖見圖A.1。
產品標識
生產標識
醫療器械制造商按照發碼機構規則和識別需求選擇生產標識組成
醫療器械制造商按照發碼機構規則分配給醫療器械產品
發碼機構分配給醫療器械制造商
圖A.1 醫療器械唯一標識結構示意圖
附錄B
（資料性附錄）
產品標識與醫療器械的包裝示意
表B.1給出了產品標識與醫療器械的包裝示意，為各級別的醫療器械包裝分配不同的產品標識，確保產品標識的唯一性。
表B.1 產品標識與醫療器械的包裝示意
單個器械或最小包裝 盒 箱
數量＝1 每個盒包裝中的數量＝9 每個箱包裝中的數量＝54
產品標識A 產品標識B 產品標識C
參考文獻
[1] ISO/IEC 646 Information technology—ISO 7-bit coded character set for information inter-change
[2] ISO/IEC 15459-4 Information technology—Automatic identification and data capture techniques—Unique identification—Part 4：Individual products and product packages
[3] ISO/IEC 15459-6 Information technology—Automatic identification and data capture techniques—Unique identification—Part 6：Groupings
[4] IMDRF UDI Working Group. UDI Guidance：Unique Device Identification（UDI） of Medical Devices[EB/OL]
http：//www.imdrf.org/docs/imdrf/final/technical/imdrf-tech131209-udi-guidance.pdf：2013-12-09
[5] Food and Drug Administration. The unique device identification system final rule[EB/OL].
https：// www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-sys-tem：2013-09-24
[6] Food and Drug Administration. UDI formats by FDA-Accredited Issuing Agency[EB/OL].
https：//www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDevicel-dentification/UDIIssuingAgencies/UCM489869.pdf：2017-01-27
[7] Food and Drug Administration. Unique Device Identification System：Form and Content of the Unique Device Identifier（UDI）.Draft Guidance for Industry and Food and Drug Administration Staff[EB/OL]
https：//www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu-ments/UCM512648.pdf：2016-07-26
