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difference between 60601 and 61010

  • 1.  difference between 60601 and 61010

    Posted 08-Sep-2020 15:12
    I'm trying to submit a De Novo for my device which is a UVC- disinfectant Chamber for the CPAP accessories and Hoses
    and the device is very simple just working with the on/off button and has an interlock switch in case someone try to open the drawer during the disinfection cycle which is only 5 minutes by the way the only contact point while the user close the drawer and press the On/off button
    I already submit a test report for the safety requirement ( IEC 601010), but the FDA not accepted the test report and asking for the IEC 60601-1 and 60601-1-2 or submit a Gap analysis and I believe that the device is very simple and there is no contact with any tissues or Gas pathway so I don't need the 60601?
    Please Advise

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    YASSER ESTAFANOUS
    Director of RA/QA
    Winter Haven FL
    United States
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