Need help?

EN 60601-1:2006/A1:2013 Standard

wave
Save  

  Keywords:

#equipment #systems #covered #iec #iso

  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

Other names: IEC 60601-1:2005/A1:2012 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. NOTE 1 See also 4.2. The IEC 60601 series does not apply to: – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or – medical gas pipeline systems covered by ISO 7396-1 [68]. NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 60601-1:2006"

  Reference

This standard supersedes the "18/01/2011"

Anyway is still possible use the "18/01/2011" until December 31st, 2017

  Related Standards

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 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 11138-2:2009

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

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

EN ISO 11138-3:2009

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

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

EN ISO 11140-1:2009

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

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 11607-1:2009

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...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0