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  • 1.  60601-1-2 EMC Manufacturer Statement in the IFU

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jun-2023 09:10
    This message was posted by a user wishing to remain anonymous

    In several medical devices' IFU I've seen a manufacturer statement for 60601-1-2 EMC testing. 

    I didn't find the source for this requirement. 

    Does anyone know the source? 

    Thanks,



  • 2.  RE: 60601-1-2 EMC Manufacturer Statement in the IFU

    Posted 15-Jun-2023 22:09

    Hello Anon

    IEC 60601-1 and IEC 60601-1-2 both have requirements for information to be provided to users regarding electromagnetic compatibility. Not sure if there's a specific type of statement you're not finding?



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: 60601-1-2 EMC Manufacturer Statement in the IFU

    Posted 16-Jun-2023 01:33

    Hi Anon,

    We had labeled the IEC60601-1-2 EMC-related information on IFU according to the guidance of USFDA.
    Here is the link to the guidance (please refer to section K) :   https://www.fda.gov/media/94758/download.

    ---
    Hsiao-Wen 
    Taiwan  




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    Hsiao-Wen Chen
    Keelung
    Taiwan
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    Original Message


  • 4.  RE: 60601-1-2 EMC Manufacturer Statement in the IFU

    Posted 16-Jun-2023 04:48

    Anon,

    Indeed the Electromagnetic Disturbance (EMD) which is now the proper term for Electromagnetic Compatibility (EMC) information needs to be included in the device information provided to user - such as the Operators Manual or Instructions for Use (IFU).  And the FDA does have a guidance for this as well which was posted above.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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