YY/T 1630-2018 PDF English
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YY/T 1630-2018: Fundamental requirements for unique device identifier
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1630-2018YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01; 35.040 C 30 Fundamental Requirements for Unique Device Identifier Issued on. DECEMBER 20, 2018 Implemented on. JANUARY 1, 2020 Issued by. National Medical Products Administration
Table of Contents
Foreword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Fundamental Principle for Unique Device Identifier... 5 5 Requirements for Device Identifier... 6 6 Requirements for Production Identifier... 6 Appendix A (Informative) Sketch Map of Structure of Unique Device Identifier 7 Appendix B (Informative) Sketch Map of Device Identifier and Medical Device Packaging... 8 Bibliography... 9Foreword
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. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of the former Medical Device Standard Management Center of China Food and Drug Administration. The main drafting organizations of this Standard. the former Medical Device Standard Management Center of China Food and Drug Administration, Chinese PLA General Hospital. The main drafters of this Standard. Yili, Yu Xinhua, He Kunlun, Mu Ruihong, Zhengjia, Xu Huiwen, Wangjian. Fundamental Requirements for Unique Device Identifier1 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 Purposes3 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. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
