GB/T 16886.3-2019: Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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Scope

This Part of GB/T 16886 specifies strategies for risk estimation, selection of
hazard (source) identification tests and risk management, with respect to the
possibility of the following potentially irreversible biological effects arising as a
result of exposure to medical devices.

Basic Data

Standard ID	GB/T 16886.3-2019 (GB/T16886.3-2019)
Description (Translated English)	Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100
Word Count Estimation	34,374
Date of Issue	2019-06-04
Date of Implementation	2020-01-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration