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.


General information 

  • Status
     : Withdrawn
    Publication date
     : 2003-10
  • Edition
     : 2
    Number of pages
     : 16
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100.20 Biological evaluation of medical devices

Life cycle

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