ISO-10993-3 › Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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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.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
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ISO-10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Document Number
ISO 10993-3:2014
Revision Level
3RD EDITION
Status
Current
Publication Date
Oct. 1, 2014
Committee Number
ISO/TC 194