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.
ОБЈАВЉЕН
ISO 10993-3:2014
ПРОЈЕКАТ
ISO/DIS 10993-3
40.60
Завршетак јавне расправе
28. 6. 2025.
Биолошко вредновање медицинских средстава – Део 3: Испитивања генотоксичности, карциногености и репродуктивне токсичности
40.60 Завршетак јавне расправе