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EN 45502-2-2:2008/AC:2009 Standard

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  Keywords:

#implantable #devices #medical #includes #tachyarrhythmia

  Directive

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

  Last Official Journal reference

Wednesday 25th of March 2020

  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 EVS-EN 45502-2-2:2008.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 45502-2-2:2008"

  Related Standards

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 17665-1:2006

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

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

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 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 13485:2016/AC:2016

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

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

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)

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