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  • 1.  HE 75

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2020 09:57
    This message was posted by a user wishing to remain anonymous

    Hi all,
    can somebody point out the differences between ANSI/AAMI HE75:2009/(R)2018 and ANSI AAMI HE75:2009/(R)2013 (this latter being recognized by the FDA)?
    What are the risks of using the 2018 version when submitting usability test to FDA?
    Thanks!


  • 2.  RE: HE 75

    Posted 26-Jan-2020 08:47
    I have not completed a specific comparison between the 2013 and 2018, but I think there were just clarifications and additional information provided.  What I would recommend is you look at the HE75 as a technical standard or guidance on practices which it is primarily intended to be from a document stand-point.  If you are looking at submitting usability testing to FDA, use their guidance document and IEC 62366 as your primary sources of compliance for usability testing.  Use HE75 as supportive information and "how to" guide on completing usability testing.  In fact, in submissions to FDA I have cited IEC 62366 as the recognised standard, but I structure my Usability Report based on the FDA guidance document; I do not cite AAMI/ANSI HE75.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: HE 75

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2020 09:09
    This message was posted by a user wishing to remain anonymous

    Thank you Richard, 
    your answer is very helpful.
    Best regards.
    Original Message


  • 4.  RE: HE 75

    Posted 28-Jan-2020 17:15
    Both cited versions of HE 75 are identical.  The "R" date was the date the version was reviewed and "Reaffirmed" as being an acceptable Technical Report.  HE 75 became the input document for the development of IEC 62366-2.  They are not identical but both contribute much valuable help in conducting usability analysis.  FDA was the driving force in HE 75 and their long experience in this area and their analysis of usability issues in medical devices made a great contribution to the success in development of these documents.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


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