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EVS-EN ISO 10993-3:2014

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

General information
Valid from 07.11.2014
Base Documents
ISO 10993-3:2014; EN ISO 10993-3:2014
Standard history
Status
Date
Type
Name
07.11.2014
Main
07.08.2009
Main
This part of ISO 10993 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. 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.
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