Any medical device that is electrically powered, by wall outlets or batteries, must have electrical safety examined by a recognized lab (UL, TUV, etc.). Basic safety is covered by IEC 60601-1 (there are small US/Canadian differences covered by the AAMI version). Basic safety covers leakage current, surface temperatures, mechanical hazards, and other energies. IEC 60601-1-2 covers emissions and susceptibility to electromagnetic signals. There are no exceptions that I know of. It doesn't matter how simple you think it is or what it does. If it has an electrical circuit at all, you must provide both test reports at a minimum.
Robert A. Kemerling, PhD
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Robert Kemerling
Chino Valley AZ
United States
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Original Message:
Sent: 08-Sep-2020 15:11
From: YASSER ESTAFANOUS
Subject: difference between 60601 and 61010
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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