Can I use CE marked Li-Ion external power bank for medical device?

eezud

Inactive Registered Visitor
#1
I want to use an external power banks for powering my device (with BF applied part). Power banks are very common and come in different capacities. I see that they are also CE certified. Can I use such CE certified power banks for my device? Doesn't CE certified means it already complies with 62133?
 
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Q

quaddoc

#2
Re: Can I use CE marked LiIon external power bank for medical device?

Hei eezud,

CE is in most cases a self-declaration of a manufacturer by itself.

First question: Do you - as a manufacturer of a medical product - want to rely basic safety of your products to a self-declaration by the manufacturer of the battery or do you want to see objective evidence that the battery fullfills all requirements of the IEC 62133?

Second question: What certifications you want to obtain with your product? If you want to do CB testing of your product, you should have a CB report of the battery according to IEC 62133. Also during NRTL certification such reports can be needed.

In any case you should try to get a CB or ILAC testreport for the battery according to IEC 62133 to have the objective evidence that the battery fullfills all the requirements.

Chris
 

eezud

Inactive Registered Visitor
#3
Re: Can I use CE marked LiIon external power bank for medical device?

Hi quaddoc,

Thank you for the reply. I have one more question. The manufacturer of the power bank claims that the battery in their product comply with 62133, so hopefully they can send me the CB report. But since this is not only battery, but a power source with some electronics inside, I guess that it has to comply also with 60950 before it can be used as a medical power supply. Doesn't it?
 
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