BAS EN ISO 10993-3:2010
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
General Information
Status: Withdrawn
No. of pages: 20
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-3:2009, identical
- ISO 10993-3:2003, identical