LiPo battery minimum requirements

[dtec2]

Hi all,

I am developing a class IIa medical device (a wearable), which is powered by a rechargeable LiPo battery. I am looking for a LiPo battery supplier, but I'm a little bit unsure on the requirements for the battery (for both Europe and USA, if possible). I have made some research and I have made the following list:

Compulsory requirements:
1. IEC 60086-4, Primary Batteries – Part 4: Safety of Lithium Batteries (requested by ANSI/AAMI ES 60601-1)
2. testing to UN 38.3 to help ensure safe shipping
3. IEC 62485-X, Safety Requirements for Secondary Batteries and Battery Installations
4. UL 1642, Lithium batteries
5. UL 2054, Household and Commercial Batteries
6. EU Battery Directive (2006/66/EC)

Nice to have:
7. IEC 62133-2:2017, Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
8. IEC 61960-3:2017, Secondary lithium cells and batteries for portable applications - Part 3: Prismatic and cylindrical lithium secondary cells and batteries made from them

However, this list seems to be overkill... Can anyone point me what's the minimum obligatory requirements for the LiPo batteries?

Thanks so much!

 

[Peter Selvey]

Prompted by this questions and some recent work with clients, I made the following article, let me know if it helps:
Li-ion batteries - the anecdotal PCM story — MEDTEQ

 

[dtec2]

That's extremely helpful Peter - thank you very much! I have now updated the list as follows:

Must have:

• Report for IEC 62133-2:2017, for the battery pack (not just the cells) and a declaration of conformity referring IEC 62133-2:2017 (dated) covering the pack with the PCM (not just the cells) - to be covered for both design and production.

OR

• UL listing to UL62133-2:2020 (fully harmonized with IEC 62133-2:2017, covers the PCM, and if the part is UL listed this means it includes a factory inspection so production is covered)

OR

• other private certification marks such as TUV SUD, TUV Rh, VDE etc, which has the latest standard (IEC 62133-2:2017) and includes factory inspection.

Nice to have / May be required in the near future:

• UN 38.3 (which covers shipping - a declaration might be needed before agencies like DHL, FedEx, UPS etc will accept batteries for shipping)
• EU battery directive - provide a practical method for removing the batteries for disposal (simply saying “dispose of according to national regulations” in the IFU may not be enough)