Objavljen
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.
POVUČEN
ISO 10993-3:2003
OBJAVLJEN
ISO 10993-3:2014
90.92
Odluka o izmeni ili reviziji standarda
27. 10. 2023.
Biološko vrednovanje medicinskih sredstava – Deo 3: Ispitivanja genotoksičnosti, karcinogenosti i reproduktivne toksičnosti
60.60 Standard objavljen