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NS-EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

standard by Standards Norway NS-EN ISO , 01/01/2015

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ADOPTED_FROM:EN ISO 10993-3:2014

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.

Product Details

Published:: 01/01/2015
Number of Pages:: 52
File Size:: 1 file , 1.3 MB
Product Code(s):: 8f355520-c2c8-4839-b6d5-e39d5997a97b, 8f355520-c2c8-4839-b6d5-e39d5997a97b, 8f355520-c2c8-4839-b6d5-e39d5997a97b