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EN 62304:2006/AC:2008 Standard

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  Keywords:

#amendment #medical #device #software #software

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical device software - Software life-cycle processesIEC 62304:2006

  Purpose

Amendment for EN 62304:2006

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 62304:2006"

  Related Standards

EN ISO 14155:2011/AC: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 11607-1:2020

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 10993-13:2010

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

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

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 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 10993-7:2008/AC:2009

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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

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