ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, 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.
OBJAVLJEN
ISO 10993-3:2014
PROJEKAT
ISO/DIS 10993-3
40.60
Završetak javne rasprave
28. 6. 2025.
Biološko vrednovanje medicinskih sredstava – Deo 3: Ispitivanja genotoksičnosti, karcinogenosti i reproduktivne toksičnosti
40.60 Završetak javne rasprave