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.
Basic Data
Standard ID
YY/T 1630-2018 (YY/T1630-2018)
Description (Translated English)
Fundamental requirements for unique device identifier
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.040.01; 35.040
Word Count Estimation
7,740
Date of Issue
2018-12-20
Date of Implementation
2020-01-01
Quoted Standard
GB/T 1988; YY/T 0287
Regulation (derived from)
State Drug Administration Announcement No. 97 of 2018
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.
