ISO 10993-3:2014
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ISO 10993-3:2014
55614

Abstract

 Preview

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.


General information 

  •  :  Published
     : 2014-10
  •  : 3
     : 34
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :
    11.100.20 Biological evaluation of medical devices

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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