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Full Description

The amendment included in this consolidated version of ANSI/AAMI/IEC 62366-1:2015 and ANSI/AAMI/IEC 62366-1:2015/A1:2020 corrects identified inaccuracies in ANSI/AAMI/IEC 62366-1:2015 while making no fundamental changes to the usability engineering process as originally conceived in that document.

The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction.
 

Document History

  1. AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text)

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    Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1

    • Most Recent
  2. AAMI/IEC 62366-1:2015


    Medical devices - Application of usability engineering to medical devices

    • Historical Version
  3. AAMI/IEC 62366:2007/(R)2013


    Medical devices - Application of usability engineering to medical devices

    • Historical Version
  4. AAMI/IEC 62366:2007


    Medical devices - Application of usability engineering to medical devices

    • Historical Version
  5. AAMI HE74:2001/(R)2009


    Human Factors Design Process for Medical Devices

    • Historical Version