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Full Description

SAME AS ISO 10993-3

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 when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. NOTE Guidance on selection of tests is provided in ISO 10993-1.

 

Document History

  1. DANSK DS/EN ISO 10993-3

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

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  2. DANSK DS/EN ISO 10993-3


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

    • Historical Version