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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Document Number: ISO 10993-3:2003
File Size: 240 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section
File Size: 240 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price:
$99.00
Product Details
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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