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Glavni meni

ISO/DIS 10993-3

Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity

Опште информације

40.60     28. 6. 2025.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

Apstrakt

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.

Životni ciklus

PRETHODNO

OBJAVLJEN
ISO 10993-3:2014

TRENUTNO

PROJEKAT
ISO/DIS 10993-3
40.60 Završetak javne rasprave
28. 6. 2025.

Nacionalna preuzimanja

Biološko vrednovanje medicinskih sredstava – Deo 3: Ispitivanja genotoksičnosti, karcinogenosti i reproduktivne toksičnosti

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