Reference number
ISO 10993-3:2003
© ISO 2025
ISO 10993-3:2003
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2
2003-10
Withdrawn
Withdrawn (Edition 2, 2003)

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     : Withdrawn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
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 2
    Number of pages
     : 16
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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