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ISO 10993-3:2003
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
standard published 10/01/2003 by International Organization for Standardization
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BS EN ISO 10993-3:2009
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity- This is the most recent version of this document.
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AAMI/ISO 10993-3:2003/(R)2009
Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity- This is the most recent version of this document.
Full Description
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.
Document History
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ISO 10993-3:2003
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity- Most Recent
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ISO 10993-3:1992
Biological evaluation of medical devices; part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity- Historical Version
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