IEC 60601-1 Class determination

CBGus

Registered
Good morning,
I am working with a client who has a medical device that is internally powered from a battery, but this battery is charged from the mains, potentially with the patient attached.
I have two questions:
1) I am assuming that this needs to be classed as a Class II medical device,
2) If the charging unit is 60601-1 certified what MOPPs would need to be incorporated.
I hope that all makes sense.
Thank you in advance.
 

mr9000

Involved In Discussions
1) If it is possible to be used while internally powered by battery AND while being charged, it is high likely to be classed as Class II medical device, since any earth connection used for safety (making it a class I device while being charged) cannot be used while being internally powered, thus it needs to be safe even without the earth connection (making it a class II when charged).
2) In the charging unit or in your device? The charging unit should incorporate 2 MOPP for mains (which most off-the-shelf units do). Plus your regular 2 MOPPs for your working voltage in the device (assuming there is also 1 MOPP for mains because the device is floating).
 
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