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EN 45502-2-2:2008 Standard

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  Keywords:

#implantable #medical #devices #corrigendum #includes

This standard can be totally or partially supervised by:
  •   EN 45502-2-2:2008/AC:2009
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

      Purpose

    Corrigendum to EN 45502-2-2:2008.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 11607-1:2009

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

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    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 11137-1:2015

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

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

    EN ISO 11135-1:2007

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

    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...

    EN ISO 10993-18:2009

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

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

    EN ISO 10993-17:2009

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

    Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

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