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Requirements for LiPo Batteries in the EU ?

#1
Hello all,

We're currently designing bluetooth headphones in which a LiPo Battery is used, the battery cannot be removed by the user and its spec are 3.7 V / ~100mAh.

The question that we're having currently is : what documents/certificate related to the battery are required to sell our product within the European Union ? (And maybe also in the United States ?)

I have stumbled across a similar post in this forum in my researches but it concerns a medical device, so maybe the requirements for non-medical devices are different ?

I must admit that I'm having a hard time grasping what is really needed or not for that topic, so if anyone has a clear answer, it would be deeply appreciated !

Thanks for the help, have a nice day :)
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
How is the battery disposed of?

EU 2006 66 EC EU Battery Directive we followed for MDD

EU asked us how much heat the battery could generate in a worst case scenario (Fire hazard)

FDA didnt focus much on our battery which is similar to yours.
 

CharlieUK

Quite Involved in Discussions
#3
Bluetooth headphones fall under the Radio Equipment Directive, which requires a safety assement

The most appropriate product standard for the headphones is EN 62368-1

EN 62368-1 requires rechargeable batteries to be compliant with IEC 62133

You will also need compliance with UN 38.3 so that you can ship batteries / product
 
#5
Just for clarification, are the aforementioned requirements/standards applicable to United States/Canada or just European Union ?

Thanks !
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
I am not sure about the USA> I will check our documentation when I am in the office next week.

For Canada, are you applying under the Interim ORder for COVID-19?
 

CharlieUK

Quite Involved in Discussions
#7
UL 62368-1 would be the applicable standard for the headphones in North America and it contains same battery requirement
 
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