Secondary button cells (LIR2540) in medical products

H

HeinzW

#1
Hi,
we are currently researching if we can use secondary button cells (LIR2540) in a medical product we develop.

As to EN 60601 secondary lithium-ion cells have to apply to IEC 62133 - but IEC 62133 just applies to all lithium-ioncells EXCEPT button cells.
[Btw. anyone knows WHY they are let out? Are they regarded "Safe" or "UNSAFE"?]

So how would the process be in that case?
Are we allowed to use the coin cells - With just doing our own risk management?
Should we let the cells be tested to IEC 62133 - would it even help since the norm does not apply?
[If so - do we need two protection circuits? One for the battery & one for the charger if they are hard wired (soldered on board)]?

As far as I know IEC 62133 should be extended to coin cells in the next version. Sadly we want to use them now. Any help is appreciated.

regards
Heinz
 
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