External power supply - requirements in safety/EMC test?

Hanna

Registered
#1
Hi all,

We're developing a medical humidifier - to be used in hospitals (no home use). In case we'll plan the device to be with an external power supply unit, will it change any applicable standard requirements (as compared to a device with an internal power unit) ? I guess it will be relevant for some requirements in the 60601-1 or 60601-1-2?

Thanks and best,
 

Marc

Captain Nice
Staff member
Admin
#2
This is a "specialty" question. A quick "Bump". Thanks in advance to anyone who can help with this.
 
#4
I think that looking at 62368 is not necessary, or relevant, as it relates to IT and AV equipment.

The external PSU may be an IT type, but if used with a humidifier it has to meet the requirements for Medical Electrical Equipment - that is the 60601 series.

Being external can cause a little difficulty in testing, but the standards are now written in such a way as to allow understanding of this situation.
Is there any particular part of the standards that is causing difficulties?
 

Jaydub

Involved In Discussions
#5
If it is a dedicated power supply for your system, some EMC tests (Conducted Emissions and Immunity, EFT, Surge) will probably be done on the AC side of the power supply. If it is something like a generic 48V power supply, some of the tests may be done on the DC side.
 

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