10.99 New project approved Nov 1, 2023
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
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.
PUBLISHED
EN ISO 10993-3:2014
IN_DEVELOPMENT
prEN ISO 10993-3 rev
10.99
New project approved
Nov 1, 2023