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EN ISO 10993-16:2010 Standard

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  Keywords:

#toxicokinetic #studies #degradation #evaluation #considerations

This standard is superseded by:
  •   EN ISO 10993-16:2017
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      Description:

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

      Purpose

    This part of ISO 10993 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.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-04-14

      Reference

    This standard supersedes the "EN ISO 10993-16:2009"

    Anyway is still possible use the "EN ISO 10993-16:2009" until August 31st, 2010

      Related Standards

    EN ISO 10993-14:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 1...

    EN 13726-2:2002

    Medical devices Directive (93/42/EEC)

    Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings

    EN ISO 10993-7:2008

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 10993-7:2008/AC:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 10993-9:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

    EN ISO 10993-11:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

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