GB/T 16886.10-2017: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

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Scope

This part of GB/T 16886 describes the evaluation steps for potential stimulation and skin sensitization of medical devices and their constituent materials.
This section includes.
a) pre-stimulation considerations, including bio-simulation experiments and in vitro methods for skin contact;
b) detailed in vivo (stimulation and sensitization) test procedures;
c) Key factors for interpretation of the results.
Appendix A gives specific material preparation instructions related to the above tests. Appendix B gives the skin removal unit for medical devices.
Several special stimulation tests outside the position.

Basic Data

Standard ID	GB/T 16886.10-2017 (GB/T16886.10-2017)
Description (Translated English)	Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	62,654
Date of Issue	2017-12-29
Date of Implementation	2018-07-01
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China