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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 10993-6:2009

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

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

    EN ISO 10993-12:2012

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

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    EN 556-2:2015

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

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN 1041:2008

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

    Information supplied by the manufacturer of medical devices

    EN ISO 10993-1:2009

    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 10993-1:2009/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)

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