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  • 1.  Medical Electrical Equipment and EMC Tables - IEC 60601-1-2

    Posted 12-Nov-2019 11:26
    It is my understanding that the IEC 60601-1-2 - 3rd edition requirement to have EMC  tables in the Instruction manual is not a requirement for the 4th Edition of IEC 60601-1-2

    Is there any requirement then to supply these EMC tables  for product sold in the U.S?

    regards
    Mike

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    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
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  • 2.  RE: Medical Electrical Equipment and EMC Tables - IEC 60601-1-2

    This message was posted by a user wishing to remain anonymous
    Posted 29-Apr-2020 09:57
    This message was posted by a user wishing to remain anonymous

    Hi Mike, 
    I see that you did not get any answer on this. I actually had the same question. 
    Do you have any update? Or can somebody please provide advice?
    Thanks
    Original Message


  • 3.  RE: Medical Electrical Equipment and EMC Tables - IEC 60601-1-2

    This message was posted by a user wishing to remain anonymous
    Posted 29-Apr-2020 17:12
    This message was posted by a user wishing to remain anonymous

    My experience is that FDA always looks for them. In 2014, the amount of tables were reduced, but there are still some that are needed. Leo Eisner is the expert on IEC 60601 and he participates in this forum occasionally.
    Original Message


  • 4.  RE: Medical Electrical Equipment and EMC Tables - IEC 60601-1-2

    Posted 01-May-2020 15:36
    I agree as well about needing the tables. I have worked on 4 510(k) submissions over the past 5 years in which the FDA required a summary table of 60601 testing to be in the IFU-- most recently in a submission that cleared in 2019.


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    Thomas Lawson PhD
    Principal Consultant
    El Cerrito CA
    United States
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    Original Message


  • 5.  RE: Medical Electrical Equipment and EMC Tables - IEC 60601-1-2

    Posted 03-May-2020 17:42
    There is a requirement for some of the EMC tables to still be in the IFU but not the same exact format.

    You still want the RF Emissions & Immunity tables just without the recommendations (so a 3 column table not a 4 column table)

    Drop the table that deals with Separation distance according to the frequency of the transmitter based on the rated maximum output power of the transmitter.

    Appropriate warnings as applicable to the device and environment the device is located in.

    You do need to include your Essential Performance as that is now required based on the newer standard.  You as the manufacturer need to write the test plan and provide it to the EMC test lab so they execute your test plan including how to run your Essential Performance of your device appropriately.

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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
    ------------------------------

    Original Message


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