Is Notification of the Test Laboratory always necessary for Supplier Changes?

[Mark Meer]

Wondering when it is necessary to update the Constructional Data Form (CDF) i.e. list of critical components, of a 60601-1 test report if information changes...

Our situation is this:
- We have an IEC 60601-1 test report issued by a 3rd party test lab.
- This has been used in an FDA 510k and part of our technical file.
- We do not, however use the NRTL mark, and hence there is no annual surveillance from the test lab.

Now, we want to have an alternate supplier for our LiIon battery.

So the question is:
- Is it absolutely necessary to inform the test lab and have them update the test-report?
- Or, is it acceptable to perform our own validation of the new supplier and process the change internally?

The battery specs are identical, the only difference is that while the first was certified to UL1642, the new one is to IEC62133 2nd Ed.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[NickM]

If you are utilizing compliance to 60601-1 as part of your regulatory submissions, you need to have a method that ensures that you meet this standard throughout the product lifecycle. If a critical component of your product changes, someone needs to assess how the change impacts compliance to 60601-1, whether it is you or a 3rd party. Regardless of who is doing it, you need to have documented objective evidence to support this change.

Nick

 

[Mark Meer]

As far as compiling the critical components list, as far as I can tell, all the test lab did was request supplier info and technical specs from us and tabulate it. Notes were made as to which were UL-listed or otherwise certified, but other than that, they didn't do any specific tests on, say, the battery.

Which is why I find it hard to justify paying them a lump more money to do what is essentially just a textual change to the critical components table.

Instead, it'd be nice if we could just validate the change internally, and create our own "addendum" to the test-report.

 

[NickM]

Since you are not trying to maintain an NRTL certification, you are free to do the analysis/justification yourself. Assuming both batteries are certified by UL, ensure you can confirm the certification through the UL certifcations directory (big counterfeit issue with batteries). Not sure if these batteries are UL Listed or Recognized, but if they are Recognized, you will want to evaluate the Conditions of Acceptability to see if the new battery has any new/different CoA's. I would also double check to see if they originally did any temperature testing of either the battery or areas close to the battery. If they did, you may need to repeat that.

 

[Mark Meer]

Thanks NickM. Good to have some reassurance that we aren't completely beholden to the test lab.

Assuming both batteries are certified by UL, ensure you can confirm the certification through the UL certifcations directory (big counterfeit issue with batteries)

And herein lies the main issue I'm struggling with. The original batteries were UL1642 certified, whereas the new ones are IEC62133(2nd ed.) tested (but not UL certified).

The original 60601-1 testing was to the 2nd edition, prior to the requirement of IEC62133 for secondary batteries in the 3rd edition.

So, as far as "state-of-the-art", the new batteries would presumably match the current 60601-1 safety requirements better than the original ones, no?

 

[NickM]

Now you complicated things! If the new battery is not certified, what objective evidence do you have from your supplier that it meets IEC 62133? Is it an internal report or 3rd party test report? It would be a red flag to me that the battery does not have any certification. How do you ensure that that battey you buy a year from now still is compliant to this standard if there is no 3rd party follow-up service activity happening?

 

[Mark Meer]

It is tested by a 3rd party, ISO/IEC 17025 accredited test lab (we have the test-report), but the battery is not NRTL marked.

The manufacturer runs an ISO9001 quality system and, as part of our supplier validation, we've also conducted an onsite facility inspection. Their controls (at present) exceeded our expectations.

True, we don't have plans to schedule future (e.g. annual) inspections and no plans to re-test periodically, so technically there is no CERTAINTY that the product remains the same, but there is a relatively high degree of confidence.

I don't see how UL-certified would make the situation any better...

 

[NickM]

It's your burden of proof to ensure that what you sell today or 3 years from now is still in compliance with 60601 and more importantly, safe for its users. If you have a robust supply chain management process, you can certainly lean on that but that would not be without risk. Having 3rd party certification (and follow-up service activities) on a battery does not eliminate the risk but certainly helps lower it. Given the failure mode of batteries (i.e, heat/fire) and the amount of recalls you see about batteries in the news, I personally would want to reduce the risk as much as possible.

 

[Peter Selvey]

NickM is correct - if there is no product certification scheme (NRTL being the most popular) there is no obligation to inform the test lab of the changes.

You do need to be careful about misrepresentation of the (old) test report. For example, if you keep it in the technical file there needs to some mechanism which identifies that parts of the report are no longer valid, and point to the location where (new) evidence of compliance is kept.

Li-ion batteries are a bit of an odd one. Although the packs are often "certified" this often comes with some quiet conditions of acceptability which are impossible to maintain in practice. For example, UL listings will often place a limit of X.XX V with the expectation that the end product manufacturer will implement protective circuits to ensure this condition is never exceeded in both normal and fault condition. The IEC standards seem to be no better.

In practice, most end product manufacturers use battery charging ICs that keep below the limit in normal condition, but this does not cover the fault condition.

At the same time, the risk of explosion is so serious that manufacturers of the battery pack will usually incorporate an electronic protection circuit inside the pack, on top of multiple protection features built into each cell. It really is serious stuff, not to be taken lightly.

The upshot is that in this particular areas the test and certification agencies appear to be behind the curve, and a bit disingenuous in they way they present a pack as "certified". Anyway, you would almost definitely be wasting your money reporting this particular change to a test lab