This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Basic Data
Standard ID
GB/T 16886.11-2021 (GB/T16886.11-2021)
Description (Translated English)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Word Count Estimation
33,378
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
