Advice for choosing Rechargeable Lithium Batteries to be used in a Medical Device

[mylene]

The reason why we hope we do not need the UL2054 is that it would cost us an extra 15K and 4 weeks time delay on our production... And we would not even think of going to the US market. So if it is not necessary for Canada, we do not want to get into that certification.

 

[Peter Selvey]

In this case you need to throw it back to the agency to show the particular clause which calls up UL 2054.

Agencies cannot make up the rules as they like, at the time of you application they need tell you exactly which standards are being applied and any additional rules they deem necessary. Any additional rules must be confirmed by a committee, written up, and made publicly available as well as highlighted at the time of application.

So, it's quite OK for an agency to say "we don't trust IEC61233, we insist on UL 2054 for all SCC marks", but it has to follow the above process. It cannot just be an individual engineer's preference.

Of course, standards are complicated and we all make mistakes. So the best way is to gently point out that it's a Canada only application, so if the agency believes UL 2054 is applicable, they need to show the exact standard, clause, requirement by which this is incorporated.

If they continue to insist on UL 2054, start a formal complaint (all agencies are required to have a formal complaints process).

If they continue to insist on UL 2054 (without being able to show the particular standard/clause/requirement), contact the accreditation agency.

 

[mylene]

Great, understood.
Just to clarify one thing... If ever the UL 2054 turns out to be necessary, like in the USA, would this UL2054 be necessary for the safety mark of the device or for its granting of the 60601-1 certification? The safety mark would come from the UL2054 or from the 60601? (I don't really understand what this safety mark is all about, I am hearing this for the first time just now... I have always been aware of the medical device standards, that is all).

 

[Peter Selvey]

Generally there are two phases in product certification:

1) test the product is OK (e.g. test against UL 60601-1)
2) confirm regular production is OK

For (1), you just need a UL 2054 report for the battery pack.

But for (2) they need to confirm critical parts like IEC inlets, fuses, power supplies and Li-ion battery packs, are also under regular surveillance (factory audits etc). This is usually by a certification mark on the part itself.

 

[mylene]

And where does the safety mark fits in there? What would it be?

 

[Peter Selvey]

It's not really a safety mark ... just a mark saying you comply with particular standards / requirements.

The mark appears on the product (or part), usually on the rating label. There are rules for the mark (e.g. size, location, etc). Ask the agency. Have a look at the power supply for your laptop, you are likely to see these marks.

 

[mylene]

Oh I see...
Tks a lot Peter!