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:
- 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.
Status: PublishedPublication date: 2014-10
Edition: 3Number of pages: 34
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
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A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Will be replaced byUnder development