Abstract
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.
General information
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Status: Under developmentStage: New project registered in TC/SC work programme [20.00]
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Edition: 4
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Technical Committee :ISO/TC 194
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Life cycle
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Previously
PublishedISO 10993-3:2014
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Now
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