Battery requirements for medical device (US/Canada/EU)

[lio_moon2]

Hi,

I would use a Lipo battery (500mAh) in my wireless medical device that will be use in direct contact with the body (over the clothes or underneath) and I wanted to ask the following questions:

- Would the CB Scheme (IEC 62133) be the only required standard to comply with in order to be able to sell in these regions?
(I know I would also need UN38.3 for transportation)

- Do a I also need to be complaint with UL62133 and CSA62133?
The battery will not be accessible and therefore not replaceable.

- The vendor which I am almost convinced to work with, has batteries with IEC62133 but not UN38.3. They say they cannot do UN38.3 as they perform custom operations in the certified packs (add of thermistor, wire termination, cutoff voltage, pulse and continuous current). It looks like they are modifying the protection circuitry. But, Is this allowed for IEC62133 approved packs? Would not it lose the certification?

Thanks for your help!

 

[MedMartin]

Hi,

maybe this information on the UL website helps you answer your questions:
Second Edition of IEC 62133 | Industries | UL

Ask your battery manufacturer or notified body about UL 62133. I am not sure if IEC and UL versions are identical but it seems when reading above link. As I understand it UN38.3 is always necessary and applies even to the cells only.

Best regards,
Martin

 

[lio_moon2]

Hello,

Yes, it was helpful. Thanks for sharing.
After some deeper research, it seems like the UL 62133 and CSA 62133 would be needed to obtain the NRTL Mark for the product. The mark is not actually required but it might be asked by hospitals and different states in the US/Canada.
The problem now is that I have not found a vendor that has already certified their batteries to UL/CSA 62133 which involves regular inspections. The closest I found was a battery that was both IEC 62133 (EN) and UL1642 compliant. I am not sure if UL1642 can be used instead of UL/CSA...

Any thoughts?

 

[MedMartin]

Hi,

the best is to ask your NRTL.

The IEC62133 is a recognized standard by the FDA:
Recognized Consensus Standards

Best regards
Martin