YY/T 1630-2018Fundamental requirements for unique device identifier (English PDF)
医疗器械唯一标识基本要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1630-2018 is the English-translated version of 医疗器械唯一标识基本要求.
YY/T 1630-2018 is the Chinese pharmaceutical industry standard that sets the fundamental requirements of the unique device identifier.
It gives the terms and definitions and the principle on which the identifier rests, then the requirements for the device identifier, the part that names the model, and for the production identifier, the part that carries the lot or serial number and the dates, so that every device can be named unambiguously and traced. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1630-2018
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Fundamental Principle for Unique Device Identifier5
- 5 Requirements for Device Identifier6
- 6 Requirements for Production Identifier6
- Appendix A (Informative) Sketch Map of Structure of Unique Device Identifier7
- Appendix B (Informative) Sketch Map of Device Identifier and Medical Device Packaging8
- Bibliography9
Foreword
This Standard was drafted in accordance with the rules in GB/T 1.1-2009.
Please be noted that certain content in this document might involve patents. The institution that issues this document shall not undertake any responsibility of identifying these patents.
1 Scope
This Standard specifies relevant terms and definitions, and fundamental principle of unique device identifier, and requirements for device identifier and requirements for production identifier.
This Standard is applicable to the management of unique device identifier.
2 Normative References
The following documents are indispensable to the application of this Standard. In terms of references with a specified date, only versions with a specified date are applicable to this Standard. The latest version (including all the modifications) of references without a specified date is also applicable to this Standard.
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
What is defined in YY/T 0287, and the following terms and definitions are applicable to this document.
3.1 Unique Device Identifier
Unique device identifier refers to a series of codes constituted of numbers, letters and/or symbols and established on the basis of standards. Unique device identifier, which includes product identifier and production identifier, is used for unique identification of medical devices.
3.2 Device Identifier
Device identifier refers to unique code which is specific to a certain specification and package of medical devices.
3.3 Production Identifier
Production identifier is the code which is used to identify relevant data in the production of medical devices.
4 Fundamental Principle for Unique Device Identifier
Fundamental principle for unique device identifier is.
5 Requirements for Device Identifier
Device identifier has the following specific requirements.
6 Requirements for Production Identifier
Production identifier shall be associated with device identifier in application. Its composition shall be determined in accordance with the requirements for device identifier.
Appendix A (Informative)
Sketch Map of Structure of Unique Device Identifier Please refer to Figure A.1 for the sketch map of the structure of unique device identifier.
Appendix B (Informative)
Sketch Map of Device Identifier and Medical Device Packaging Table B.1 provides a sketch map of device identifier and packaging of medical device.
It distributes different device identifiers to various levels of medical device packaging, which guarantees the uniqueness of device identifier.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
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Related Standards
GB/T 1988-1998 — Information technology. 7-bit Coded character set for information interchange
YY/T 0287-2003 — Medical devices - Quality management systems - Requirements for regulatory purposes
YY/T 0287-2017 — Medical devices-Quality management systems- Requirements for regulatory purposes
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