GB/T 16886.9-2022: Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
This Document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the GB/T (Z) 16886 series.
Basic Data
Standard ID
GB/T 16886.9-2022 (GB/T16886.9-2022)
Description (Translated English)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.100.20
Word Count Estimation
14,181
Date of Issue
2022-12-30
Date of Implementation
2024-01-01
Older Standard (superseded by this standard)
GB/T 16886.9-2017
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
