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ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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Abstract
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.
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Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.92 (2009-11-04) TC/SC: ISO/TC 194 Number of Pages: 16 -
Revised by: ISO/DIS 10993-3.2
Revises: ISO 10993-3:1992
