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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 14937:2009

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

    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

    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 13485:2016

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 13408-7:2015

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

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN ISO 13408-1:2015

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

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

    EN ISO 11737-2:2009

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

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

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