iso / tc 194 - Biological and clinical evaluation of medical devices

  • ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
  • ISO/TR 15499:2012 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

 

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