YY/T 1630-2018 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1630-2018 | English | 125 |
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Fundamental requirements for unique device identifier
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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/YYT1630-2018
YY
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... 9
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.
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 Identifier
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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