IEC 62133 cell vs. Battery Pack - Certification on the cell only

[FLAGA20]

We are a medical device manufacturer using an IEC62133 certified, single cell Li-ion battery pack (not user accessible) for a portable device. The pack we are using is no longer going to be available and we are in the market for a replacement. I am able to find replacement packs that have IEC62133 certification for the individual cell but not the assembled pack.

Does anyone have experience as to whether certification on the cell only is sufficient for a device that is IEC 60601-1 compliant or does the assembled pack need to carry the certification?

Thanks

 

[yodon]

Pretty sure it has to be cell & pack since the pack will likely contain any safety circuitry. If you use a test lab, discuss with them.