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ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

standard by International Organization for Standardization , 10/01/2014

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Full Description

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

  • genotoxicity;
  • carcinogenicity;
  • reproductive and developmental toxicity.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

 

Product Details

Published:
10/01/2014
Number of Pages:
42
File Size:
1 file , 960 KB
Same As:
DIN EN ISO 10993-3, BS EN ISO 10993-3:2014
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-3:2014

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    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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  2. ISO 10993-3:2003


    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version