90.92 Standard to be revised Oct 27, 2023
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
Published
ISO 10993-3:2014 specifies 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.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
WITHDRAWN
ISO 10993-3:2003
PUBLISHED
ISO 10993-3:2014
90.92
Standard to be revised
Oct 27, 2023
