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  • 1.  Documents needed for EMC testing

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jan-2024 10:14
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    We are preparing for EMC testing of our medical device (60601-1-2 and EMC requirements from some particular standards) for compliance in three different markets of interest.

    The question is, what kind documentation do we need to prepare for the testing lab (e.g. UL)? Do we, the manufacturer, need to write a test plan? How is this responsibility delegated? 

    Any input will be a great guidance and advice. Thank you!



  • 2.  RE: Documents needed for EMC testing

    Posted 16-Jan-2024 01:18

    The manufacturer, you, need to write the test plan.  In IEC 60601-1-2:2014+A1:2020, sub-cl 6.2 requires that a test plan shall be provided to the test lab (i.e. the manufacturer needs to provide it to the test lab as the test lab can't determine how to test your product you know it better than anyone else).

    Annex G provides Guidance on the recommended content of a test plan.

    Please note one of the critical items of an EMC test plan that is missed and that the FDA is very critical about is that Essential Performance needs to well defined and clear in the test plan as that has a significant impact on the EMC testing.



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

    Original Message


  • 3.  RE: Documents needed for EMC testing

    Posted 16-Jan-2024 09:11
    Edited by Wade Munsch 16-Jan-2024 09:13

    I addition to what Leo has stated you also need to have completed some risk management activities in order to determine and support the pass/fail limits you determine for your equipment. If your equipment is determined to be used in a Special Environment then you will have much more work to do in determining appropriate tests and their associated test levels. 

    If the test lab is performing a full evaluation of the equipment against the standards (as they should) and not just the testing, they will also need a copy of the instructions for use and may need a copy of the labeling.



    ------------------------------
    Wade Munsch
    Director of Regulatory Affairs
    Biotex, Inc.
    Houston TX
    United States
    Company Website: www.biotexmedical.com
    Test Lab Website: https://www.biotexmedical.com/criterion/
    ------------------------------

    Original Message


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