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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This standard is superseded by: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 14155:2020

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

    EN ISO 10993-9:2009

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

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

    EN ISO 14155:2011

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    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 10993-16:2017

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

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

    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)

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