Abstract

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IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.


General information 

  • Status
     : Published
    Publication date
     : 2016-04
  • Edition
     : 1
    Number of pages
     : 94
  • Technical Committee
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    11.040.01 Medical equipment in general

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