This standard was last reviewed and confirmed in 2023.
Therefore this version remains current.
Abstract
PreviewISO 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.
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Status: PublishedPublication date: 2014-10
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Edition: 3Number of pages: 34
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- ICS :
- 11.100.20 Biological evaluation of medical devices
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| Format | Language | |
|---|---|---|
| std 1 145 | PDF + ePub | |
| std 2 145 | Paper |
- CHF145
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