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ISO 10993-3:2003

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

General information

Withdrawn from 24.09.2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
24.09.2014
Main
Main
ISO 10993-3:1992
ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Guidance on selection of tests is provided in ISO 10993-1.

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