ISO has updated part three of its series on the biological evaluation of medical devices, detailing testing strategies for genotoxicity, carcinogenicity and reproductive and developmental toxicity. The genotoxicity testing strategy has been updated to encompass an in vivo test and a follow-up evaluation. The updated guidance includes furtherin vitro andin vivo tests to evaluate the genotoxic potential of medical devices, and a newly-released annex provides guidance on in vitro tests for embryo toxicity. A supplement, providing guidance on tests to evaluate genotoxicity, is currently in preparation.

International Organization for Standardization. Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. September 2014. Available for purchase via


The above items were taken from the December 2014 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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