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ISO/DIS 10993-3

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

General information

40.20     Apr 4, 2025

ISO

ISO/TC 194

International Standard

11.100.20  

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 10993-3:2014

NOW

IN_DEVELOPMENT
ISO/DIS 10993-3
40.20 DIS ballot initiated: 12 weeks
Apr 4, 2025

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