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sklademVydáno: 2014
ISO 10993-3:2014
ISO 10993-3:2014-Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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| Označení normy: | ISO 10993-3:2014 |
| Počet stran: | 34 |
| Vydání: | 3 |
| Vydáno: | 2014 |
Popis
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.
