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EN 60601-1:2006/A1:2013 Standard

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  Keywords:

#equipment #systems #covered #iec #iso

  Directive

Medical devices Directive (93/42/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 "EN 60601-1:2006/AC:2010"

Anyway is still possible use the "EN 60601-1:2006/AC:2010" until December 31st, 2017

  Related Standards

EN ISO 10993-1:2009

Medical devices Directive (93/42/EEC)

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EN ISO 10993-6:2009

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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 10993-5:2009

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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-4:2009

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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-3:2014

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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

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