This Standard stipulates the analytical method for bioburden control level of medical device. This Standard applies to the analysis of bioburden control levels of sterile and implantable medical devices. This Standard is not applicable to the analyses performed to validate bioburden test values for products during the development phase.
Basic Data
Standard ID
YY/T 1737-2020 (YY/T1737-2020)
Description (Translated English)
Analytical method for bioburden control level of medical device
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C47
Classification of International Standard
11.080.01
Word Count Estimation
15,113
Date of Issue
2020-09-27
Date of Implementation
2021-09-01
Regulation (derived from)
Announcement No. 108 (2020) of the National Medical Products Administration
