This Document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
Basic Data
Standard ID
GB/T 16886.10-2024 (GB/T16886.10-2024)
Description (Translated English)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.100.20
Word Count Estimation
50,563
Date of Issue
2024-08-23
Date of Implementation
2025-09-01
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
