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ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityMore info
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.
| Author | ISO/TC 194 Biological and clinical evaluation of medical devices |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Number of pages | 34 |
| Replace | ISO 10993-3:2003 |
| Weight(kg.) | 0.1578 |
| Year | 2014 |
| Country | Switzerland |