ISO/TR 10993-33:2015 Preview

Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3

There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.


General information

  • Status :  Published
    Publication date : 2015-03
  • Edition : 1
    Number of pages : 47
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

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