Proper document of SMPS used in infant warmer for IEC 60601-1 testing

#1
I am testing an infant incubator which contains SMPS. It is an approved product and the document is also given as per IEC 62368-1:2014. Is this document valid? as I understand that IEC 62368 is for audio/video and IT equipment.
 
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Benjamin Weber

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#2
This depends on the way the electrical insulation concept is designed. If there are only means of operator protection implemented by the power supply, then IEC 62368 compliance should be sufficient (see also figuer A.12 in 60601, ed. 3.1, and replace 60950 by 62368) . But as soon as there is a means of patient protection implemented by the power supply, you have to be very careful if 62368 compliance fullfils requirements of 60601 (test voltage for solid insulatin, creepages and clearances).

Very often the power supply is used to achieve the required 2 MOPP against mains voltage from the mains supply. If the 2 MOPP cannot be achieved by other means in the device (e.g. separation within the secondary circuits) 62368 compliance is not sufficient.
 
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