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  • 1.  IEC 60601-1

    This message was posted by a user wishing to remain anonymous
    Posted 06-Feb-2019 15:01
    This message was posted by a user wishing to remain anonymous

    Hello everyone, 

    For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers? 

    Thank you.

  • 2.  RE: IEC 60601-1

    Posted 07-Feb-2019 11:48
    I have found greenlight guru to be very helpful when learning the basics with 60601-1 standards. Here is a link that states 15 steps to getting approval for IEC 60601-1: (

    What I would do first is read the standard, see which areas apply and familiarize yourself with the collateral standards. Here is a website that mentions a bit about the collateral standards: . Not all of the general standard and collateral standard will apply to your device but it will be a nice foundation knowing exactly what areas to reference. 

    If you have some money to spare and want more in depth knowledge from experts, Intertek and UL  have training's they offer a few times a year in different locations in the US ( Intertek also has some good information on their website including white papers and a webinar ( . I will say this, if you are using UL to get get 60601-1 certified than use their training (likewise with Intertek). 

    The general standard can be overwhelming but just carve out some time here and there to review piece by piece and you'll become familiar. 

    Hope this helps,

    April Corella
    Temecula CA
    United States

  • 3.  RE: IEC 60601-1

    Posted 08-Feb-2019 04:32
    As April mentioned there are lots of helpful information out there that boils the hundred page standard down to something that is useful for a lay-person to use.  We also have some experts in this forum like Leo Eisner who are experts in those standards that have published information - if you search this forum for IEC 60601-1 there are some links provided to helpful information.  I would also recommend to search on IEC 60601-1 version "3.1" differences as from version 3.0 to 3.1 there were some meaningful changes that are quite important.  And of course, you can contact your testing laboratory that you may be using for the safety testing as they usually have much helpful information, checklists, and guides to follow for compliance.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: IEC 60601-1

    Posted 08-Feb-2019 08:06
    Great information April.

    Anonymous, Leo Eisner is Mr. IEC 60601-1... 

     For great consulting on this you can contact him at Eisner Safety Consultants.  

    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA

  • 5.  RE: IEC 60601-1

    Posted 09-Feb-2019 03:28
    First Thank you to Ginger & Richard for those nice words. 

    My site has some additional resources not mentioned yet.
    My blog which includes articles that are more recent.  Also, you can click on the ESC Hot topics on the Right side of the page on 60601-1 or other hot topic words and find more posts that way.
    For older articles go to Eisner Safety Consultants many of which are on IEC 60601-1.
    Some useful links which include test labs, standards organizations, etc.

    One thing I would like to clarify that Richard mentioned.  Most test labs won't provide you with the checklists unless you are a client of their's or sometimes you may get them if you have a proposal from them.  Each lab is a little different on this issue.

    I am on the standards committees that write the IEC 60601 standards (there are a lot in the series), I present around the world on this topic.

    Please feel free to contact me to have a 1/2 hr free call.  Go to Eisner Safety Consultants.

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