IEC/TR 62366-2:2016 Preview

Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices

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

  • Current status : Published
    Publication date : 2016-04
  • Edition : 1
    Number of pages : 94
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 11.040.01
    Medical equipment in general

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