Flame Resistance of Primary Cell Battery Packs Regulatory Requirement

mdtguts

Registered
Hi Community SMEs,
Does anyone know if the MDD or FDA requires flame resistance of primary cell battery packs?

I'm working on a project and have heard that our primary cell battery pack plastic enclosure needs to meet UL 94 V-0. Although the batteries are Lithium, they are not rechargeable; they're Lithium Manganese Dioxide chemistry, not Lithium Ion. There is no easy way to reach the contacts (the pack design is at least IP-2,2). The battery cells also have internal PTCs and the pack has a 93°C TCO.

Any direction on this would be greatly appreciated!
Thanks in advance,
 

DanMann

Quite Involved in Discussions
Depends what the device is, but have you looked at requirements under IEC 60101 or IEC 61010 or similar (both harmonised/recognised standards)? Also, the requirements may not be under medical device regulations, but instead under electronic device safety regulations (e.g. low voltage directive in Europe).
 

mdtguts

Registered
Depends what the device is, but have you looked at requirements under IEC 60101 or IEC 61010 or similar (both harmonised/recognised standards)? Also, the requirements may not be under medical device regulations, but instead under electronic device safety regulations (e.g. low voltage directive in Europe).
Thanks @DanMann , I have looked at 60601, but will re-look. And, I have not yet checked 61010, so thanks for the pointer.
One thing I considered, as a thought experiment, is whether we would be considering flame resistance if our cells were alkaline primaries (i.e., 7S1PXAA versus 4S1PxCR123a cells).
 

DanMann

Quite Involved in Discussions
If you can give a basic description of the product, I can tell whether IEC 60601 is applicable and if so, it has a fair amount of guidance on power sources and batteries. Regulators tend to point to product standards (which then point to component standards), rather than directly to component standards.
 

mdtguts

Registered
If you can give a basic description of the product, I can tell whether IEC 60601 is applicable and if so, it has a fair amount of guidance on power sources and batteries. Regulators tend to point to product standards (which then point to component standards), rather than directly to component standards.
Sure, the batteries power a disposable sterile surgical device used in the operating room.
 

DanMann

Quite Involved in Discussions
I'm assuming the device comes into contact with the patient? If so, it would fall under the category of "Medical Electrical Equipment", which is the score of the IEC 60601 series of standards; it will definitely include some guidance on what is required of batteries, but it is a long series of standards requiring testing of the device at a recognised test house and (for sales in the US) frequent unannounced inspections of your manufacturing facilities.
 
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