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EN 60601-1:2006/AC:2010 Standard

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  Keywords:

#general #performanceiec #essential #safety #basic

  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

  Correction

This standard is a correction for "EN 60601-1:2006"

  Related Standards

EN ISO 10993-11:2018

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

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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