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  • 1.  Does IEC 62366-1 replace IEC 60601-1-6 ?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Aug-2023 13:58
    This message was posted by a user wishing to remain anonymous

    I am asking since IEC 60601-1 reference IEC 62366-1 and IEC 60601-1-6  and FDA recognizes both

    Thanks,



  • 2.  RE: Does IEC 62366-1 replace IEC 60601-1-6 ?

    Posted 02-Aug-2023 19:36

    Not entirely. The 62366 standards were built upon the older 60601-1-6. Then 60601-1-6 was revised to strip out most of its content in favor of pointers to 62366-1 and 62366-2. There are just a few requirements remaining in 60601-1-6. The next revision of the general standard may absorb those last few bits of 60601-1-6 and point directly to 62366-1 as the collateral standard.

    The introduction to 60601-1-6 describes its current status as a sort of middleman:  https://webstore.iec.ch/preview/info_iec60601-1-6%7Bed3.2%7Db.pdf



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Does IEC 62366-1 replace IEC 60601-1-6 ?

    Posted 03-Aug-2023 01:55
    Edited by Richard Vincins 03-Aug-2023 01:55

    Anon,

    Also for clarification, the IEC 60601-1-6 is applicable to Electromechanical medical device products only - whereas IEC 62366-1 is applicable to all medical devices.  At one point they were actually going to remove IEC 60601-1-6 since IEC 62366 existed, but then much of the content was moved to IEC 62366-1.  As Anne indicated, today the standard is really just a "bridge" between IEC 60601-1 usability/use requirements and IEC 62366-1.

    If you have an Electromechanical device it would be proper to cite both IEC 60601-1-6 and IEC 62366-1.  If your product is non-electromechanical, then citing of only IEC 62366-1 would be needed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Does IEC 62366-1 replace IEC 60601-1-6 ?

    Posted 03-Aug-2023 03:26

    For the next edition of the IEC 60601-1 (the 4th ed.) the design specification is in development currently.  The concept is that all the collateral standards (i.e. IEC 60601-1-XX standards) would be folded into the general standard IEC 60601-1 as the hope is to have a database standard.  This would mean IEC 60601-1-6 would be one of those standards that would be impacted by this decision.  So, Anne's comment about direct references to IEC 62366-1 would be a possibility but the design specification is not that clear to provide that much guidance yet.  I think once the TC62 & SC62A new Working Groups start writing the requirements based on the guidance from the design spec we will have a better idea if this will happen in the 4th ed. of IEC 60601-1.  Realize, the 4th ed. of the standard is probably at least another 5 years off, or more (my best guess)  



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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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    Original Message


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