ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publication date:   Sep 24, 2014

General information

90.92 Standard to be revised   Dec 16, 2019

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-3:2003

NOW

PUBLISHED
ISO 10993-3:2014
90.92 Standard to be revised
Dec 16, 2019

REVISED BY

IN_DEVELOPMENT
ISO/CD 10993-3