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EN 60601-1-2:2015 Standard

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  Keywords:

#systems #equipment #safety #essential #performance

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60601-1-2:2014

  Purpose

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. Specifically, this collateral standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES of ME EQUIPMENT and ME SYSTEMS. Applicability of this collateral standard includes ME EQUIPMENT and ME SYSTEMS that have been found to have no ESSENTIAL PERFORMANCE. BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES shall be evaluated for all ME EQUIPMENT and ME SYSTEMS.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-1-2:2007"

Anyway is still possible use the "EN 60601-1-2:2007" until December 31st, 2018

  Related Standards

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EN ISO 18777:2009

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EN ISO 17510-2:2009

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EN ISO 17510-1:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

EN ISO 16201:2006

Medical devices Directive (93/42/EEC)

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

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CLICK HERE TO GET TESTS AND INFO ON THE EN 60601-1-2:2015 STANDARD

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