Regulatory Open Forum

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  • 1.  EMC- Declaration of conformity tables

    Posted 16-Jul-2020 10:36
    Dear RAPS members,

    I would like to know whether do we have to include the EMC- Declaration of conformity tables in IFU. My understanding was that the 4th edition of IEC60601-1-2 no longer requires these tables. 

    Appreciate, if you can share your knowledge on this matter.

    Thanks!

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
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  • 2.  RE: EMC- Declaration of conformity tables

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jul-2020 14:28
    This message was posted by a user wishing to remain anonymous

    My understanding (from having used the consulting services for three products of Leo Eisner, who posts frequently on this board) is that the tables are still needed, but much less information is needed in them than previously required.