ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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ISO 10993-3 Document Information:

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

International Organization for Standardization

Publication Date:
Oct 15, 2003

Scope:

This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:

— genotoxicity,

— carcinogenicity, and

—  reproductive and developmental toxicity.

This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

NOTE Guidance on selection of tests is provided in ISO 10993-1.

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