Regulatory Open Forum

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  • 1.  The Future of the IEC 60601 Series: An Update

    Posted 07-Nov-2019 03:01
    Read the article I wrote for InCompliance Magazine recently. I just got back from China at the end of Oct 2019 where I was at IEC meetings for 2 weeks working on IEC 60601-1, edition 3.2 and it's collaterals and discussing the 4th edition architecture, as well. This article discusses all of this and where things are headed. Hold on as things are continuing to change.  This is why I am on standards committees.  To keep up to date, to be at the "state of the art", work with those in industry, regulators, test houses, and other experts, to stay up to date on the standards that are constantly changing and being able to help my clients through the process, and much more. 
    If you like the article please Like it on LinkedIn or post a comment at this link.
    I hope you enjoy this article.



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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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  • 2.  RE: The Future of the IEC 60601 Series: An Update

    Posted 08-Nov-2019 04:37
    Thanks for this Leo and all the updates along with future activities is really great to read about !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: The Future of the IEC 60601 Series: An Update

    Posted 08-Nov-2019 11:35
    Hi Richard,

    Thank for the nice comment.  Would appreciate the comment on LinkedIn to draw more eyes on LinnkedIn, if possible.  That will draw more attention to the article and different audience if you like it and also comment on it.  The more people from RA/QA that get involved in IEC 60601 and understand more than just the super high level would be to the benefit of that group is my perspective as I see a weakness in general.  I am not trying to critique this group I just, as a consultant for 20+ year have seen that this group as a whole has not understood the standard well and needed lots of support from me and others.  So, the more information they can obtain on IEC 60601 series the better off they would be.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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