ISO 10993-16:2017 Preview

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

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.


General information

  • Status :  Published
    Publication date : 2017-05
  • Edition : 3
    Number of pages : 13
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

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