
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
出版:International Organization for Standardization

专家解读视频
Describes strategies for risk estimation, selection of hazard 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: - genotoxicity - carcinogenicity, - reproductive and developmental toxicity.
CSA ISO 10993-3 : 1997 - Identical
NEN ISO 10993-3 : 1994 - Identical
GOST R ISO 10993-3 : 2009 - Identical
NS ISO 10993-3 : 1ED 1994 - Identical
GOST ISO 10993-3 : 2011 - Identical
SAC GB/T 16886.3: 2019 - Identical
SANS 10993-3 : 1ED 2004(R2009) - Identical
PN EN ISO 10993-3 : 2014 - Identical
DS EN ISO 10993-3 : 2014 - Identical
SS-EN ISO 10993-3:2014 - Identical
AAMI ISO 10993-3 : 2014 - Identical