ISO 10993 3:2014 PDF
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Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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.
| Edition | 2014 |
|---|---|
| Standard Part No | 3 |
| Published Date | 2014 |
| Published By | International Standardization Organisation |
| Page Count | 34 |
