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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This standard is superseded by: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
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      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

      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 10993-11:2018

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

    EN ISO 10993-18:2020

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

    EN ISO 10993-1:2009/AC:2010

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

    EN ISO 10993-3:2014

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

    EN ISO 10993-4:2009

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

    EN ISO 10993-5:2009

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

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