ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Guidance on selection of tests is provided in ISO 10993-1.
Status: WithdrawnPublication date: 2003-10
Edition: 2Number of pages: 16
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
ISO 10993-3:2003Stage: 95.99
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