YY/T 1630-2018 (YY/T1630-2018, YYT 1630-2018, YYT1630-2018)
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| YY/T 1630-2018 | English | 125 |
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Fundamental requirements for unique device identifier
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YY/T 1630-2018
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| Standard ID | YY/T 1630-2018 (YY/T1630-2018) | | Description (Translated English) | Fundamental requirements for unique device identifier | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01; 35.040 | | Word Count Estimation | 7,781 | | Date of Issue | 2018-12-20 | | Date of Implementation | 2020-01-01 | | Quoted Standard | GB/T 1988; YY/T 0287 | | Drafting Organization | Former State Food and Drug Administration, Medical Device Standards Management Center | | Administrative Organization | Former State Food and Drug Administration, Medical Device Standards Management Center | | Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the relevant terms and definitions, basic principles, product identification requirements and production identification requirements for the unique identification of medical devices. This standard applies to the management of the unique identification of medical devices. |
YY/T 1630-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
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.
NOTE 1. the word “unique” does not signify serialized management of individual products.
NOTE 2. it can be used for the management and tracing of medical device products.
NOTE 3. at present, UDI is generally adopted to represent unique device identifier in the
world.
3.2 Device Identifier
with international standards, such as ISO/IEC 15459-4 and ISO/IEC 15459-6,
or other appropriate modes;
c) In accordance with the specific service condition, there shall be corresponding
verification mechanism. Unique device identifier shall be obtained through
standard algorithm, through which, the correctness of the whole or constituent
parts of unique device identifier can be verified;
d) The length of unique device identifier shall be as brief as possible;
e) Data delimiter shall be included, so as to guarantee that the various constituent
parts of device identifier and production identifier can be correctly interpreted
and analyzed.
Please refer to Appendix A for a sketch map of the structure of unique device identifier.
5 Requirements for Device Identifier
Device identifier has the following specific requirements.
a) Device identifier shall identify medical device’s manufacturer and product
information;
b) Device identifier shall maintain its uniqueness on various levels of device
packages (please refer to Appendix B for details).
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.
a) When the batch number of medical devices needs to be identified, production
identifier shall include batch number;
b) When individual product of medical devices needs to be identified, production
identifier shall include serial number;
c) When production date of medical devices needs to be identified, production
identifier shall include production date;
d) When expiration date of medical devices needs to be identified, production
identifier shall include expiration date.
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