ISO 10993-16:2010 Preview

Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.


General information

  • Current status : Published
    Publication date : 2010-02
  • Edition : 2
    Number of pages : 11
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

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