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EN 60601-1-6:2010 Standard

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  Keywords:

#use #usability #associated #risks #equipment

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityIEC 60601-1-6:2010

  Purpose

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-1-6:2007"

Anyway is still possible use the "EN 60601-1-6:2007" until April 1st, 2013

  Related Standards

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