Regulatory Open Forum

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  • 1.  IEC 60601-1 3rd edition

    Posted 07-Feb-2014 13:19
    Dear All:

    I'm aware that the deadline for IEC 60601-1 3rd edition was extended to December 31, 2013.  Does anyone know if the IEC 60601-1 3rd edition testing is required for a Special 510(k) submission?  The device was previously cleared with the IEC 60601-1 2nd edition testing.  Are there any guidelines out on this?  Thanks.

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    Jhung Won Vojir, Ph.D.
    Global Regulatory Officer
    Lutronic
    Trevose, PA
    United States
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  • 2.  RE:IEC 60601-1 3rd edition

    Posted 08-Feb-2014 08:34
    For the U.S., it is my understanding that the product can continue to be distributed as originally validated under IEC 60601-1 Edition 2, however, if an additional 510(k) is required for newer product changes or modifications, then the product will have to be re-validated under IEC 60601-1 Edition 3.

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    Robert Wilkinson
    President
    Resolute Regulatory Affairs Consulting Service, Inc
    Port Barrington IL
    United States
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    Original Message


  • 3.  RE:IEC 60601-1 3rd edition

    Posted 08-Feb-2014 20:05
    Here is a link from an expert in the area of IEC 60601 and the US FDA.  I think you can get all the latest information you need from Leo. He is well qualified to answer your questions.

    http://lnkd.in/bJ9Yu2s

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    Edwin Bills RAC
    Principal Consultant
    ELB Consulting
    Butler KY
    United States
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    Original Message