ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
This standard has an identical version adopted as a Singapore Standard. The adopted Singapore version has the same content as this version and is available at a significantly lower cost. To view and / or purchase the adopted Singapore Version, click here .
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2014 |
| No. of Pages | 34 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | ISO/TC 194 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |