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Greetings,
I'm working on a Class II handheld, Li-Ion battery powered medical device.
We expect to build it in the US and sell it worldwide.
I need some help understanding to which US and EU standards/regulations the battery needs to be tested. This is a single cell Li-Ion battery that includes overcharge/over-discharge safety circuitry.
I have received feedback from one battery supplier that if the battery is user replaceable, it will have to undergo testing to UL2054 independent of any testing done for the device and that if the battery is not user replaceable, its testing becomes part of the device system testing.
Is it true that separate battery testing is required? If so, to which standards should we test?
Does anyone have experience with what additional steps may be needed to certify a battery separate from its device?
Thanks for your help,
-Bryan
I'm working on a Class II handheld, Li-Ion battery powered medical device.
We expect to build it in the US and sell it worldwide.
I need some help understanding to which US and EU standards/regulations the battery needs to be tested. This is a single cell Li-Ion battery that includes overcharge/over-discharge safety circuitry.
I have received feedback from one battery supplier that if the battery is user replaceable, it will have to undergo testing to UL2054 independent of any testing done for the device and that if the battery is not user replaceable, its testing becomes part of the device system testing.
Is it true that separate battery testing is required? If so, to which standards should we test?
Does anyone have experience with what additional steps may be needed to certify a battery separate from its device?
Thanks for your help,
-Bryan