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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
中华人民共和国医药行业标准
YY/T 1630—2018
医疗器械唯一标识基本要求
Fundamental requirements for unique device identifier
2018-12-20发布 2020-01-01实施
国家药品监督管理局 发布
前言
本标准按照GB/T 1.1—2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家药品监督管理局提出。
本标准由原国家食品药品监督管理总局医疗器械标准管理中心归口。
医疗器械唯一标识基本要求
1 范围
本标准规定了医疗器械唯一标识的相关术语和定义、基本原则、产品标识的要求和生产标识的要求。
本标准适用于医疗器械唯一标识的管理。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 1988 信息技术 信息交换用七位编码字符集
YY/T 0287 医疗器械 质量管理体系 用于法规的要求
3 术语和定义
YY/T 0287界定的以及下列术语和定义适用于本文件。
3.1
医疗器械唯一标识 unique device identifier
基于标准创建的一系列由数字、字母和/或符号组成的代码,包括产品标识和生产标识,用于对医疗器械进行唯一性识别。
注1:“唯一”一词并不意味着对单个产品进行序列化管理。
注2:可用于医疗器械产品的管理和追溯等。
注3:目前国际上通常使用UDI表示unique device identifier.
3.2
产品标识 device identifier
特定于某种规格型号和包装医疗器械的唯一性代码。
注1:产品标识可用作对医疗器械唯一标识数据库存储信息的“访问关键字”,关联医疗器械产品信息、制造商信息、注册信息等。
注2:目前国际上通常使用UDI-DI表示device identifier。
3.3
生产标识 production identifier
识别医疗器械生产过程相关数据的代码。
注1:根据实际应用需求,生产标识可包含医疗器械序列号、生产批号、生产日期、失效日期等。
注2:目前国际上通常使用UDI-PI表示production identifier。
3.4
数据分隔符 data delimiter
在医疗器械唯一标识中,定义特定数据元素的字符或字符集。
注:数据分隔符示例为应用标识符(AD)、对象标识符(OID)等。
4 医疗器械唯一标识的基本原则
医疗器械唯一标识的基本原则是:
a) 使用字符应符合GB/T 1988或相关国际标准;
注:相关国际标准如ISO/IEC 646。
b) 医疗器械唯一标识应能在医疗器械规格型号、批次或单个产品层次保持唯一。对于相同特征的医疗器械,医疗器械唯一标识的唯一性应指向单个规格型号产品;对于按照批次生产控制的医疗器械,医疗器械唯一标识的唯一性应指向同批次产品;对于采用序列号生产控制的医疗器械,医疗器械唯一标识的唯一性应指向单个产品。可通过符合国际标准,如ISO/IEC 15459-4和ISO/IEC 15459-6,或者通过其他适当的方式实现;
c) 应根据具体使用情况有相应的校验机制,由标准的算法得出,以校验医疗器械唯一标识整体或组成部分的正误;
d) 医疗器械唯一标识的长度应尽可能简短;
e) 应包括数据分隔符,保证产品标识和生产标识的各组成部分能够正确识读和解析。
医疗器械唯一标识的结构示意图参见附录A。
5 产品标识的要求
产品标识的具体要求是:
a) 应识别医疗器械制造商、产品信息;
b) 应在各级别的器械包装上保持唯一(参见附录B)。
6 生产标识的要求
生产标识应与产品标识联合使用,其组成应根据产品的识别要求确定;
a) 对于需要识别医疗器械批次的,应包括生产批号;
b) 对于需要识别医疗器械单个产品的,应包括序列号;
c) 对于需要识别医疗器械生产日期的,应包括生产日期;
d) 对于需要识别医疗器械失效日期的,应包括失效日期。
附录A
(资料性附录)
医疗器械唯一标识结构示意图
医疗器械唯一标识结构示意图见图A.1。
产品标识
生产标识
医疗器械制造商按照发码机构规则和识别需求选择生产标识组成
医疗器械制造商按照发码机构规则分配给医疗器械产品
发码机构分配给医疗器械制造商
图A.1 医疗器械唯一标识结构示意图
附录B
(资料性附录)
产品标识与医疗器械的包装示意
表B.1给出了产品标识与医疗器械的包装示意,为各级别的医疗器械包装分配不同的产品标识,确保产品标识的唯一性。
表B.1 产品标识与医疗器械的包装示意
单个器械或最小包装 盒 箱
数量=1 每个盒包装中的数量=9 每个箱包装中的数量=54
产品标识A 产品标识B 产品标识C
参考文献
[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