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EN 60601-1:2006 Standard

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  Keywords:

#general #performanceiec #essential #safety #basic

This standard can be totally or partially supervised by:
  •   EN 60601-1:2006/AC:2010
  •   EN 60601-1:2006/A1:2013
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

      Purpose

    Amendment to EN 60601-1:2006

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN 60601-1:1990 + A13:1996 + A1:1993 + A2:1995"

    Anyway is still possible use the "EN 60601-1:1990 + A13:1996 + A1:1993 + A2:1995" until June 1st, 2012

      Related Standards

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    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 13408-4:2011

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

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN 60601-1:2006/AC:2010

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

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

    EN 45502-1:1997

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

    Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufa...

    EN ISO 11607-2:2020

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

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 14155:2020

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

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