Reducing cost of IEC 60601 3rd edition testing

[Mark Meer]

Hi Everyone,

Getting staggering quotes from tests labs for 3rd Ed. 60601 testing, and wondering if anyone has advice on how to get the price down.

From the device information we provided, the tests labs suggested the following items I'm not so sure about:

1. ISO 14971 (~8$K!!) - Does a test-lab assessment provide any value? Isn't examination of the risk file already part of 60601-1 testing?
2. IEC/EN 60601-1-6 (~$6K) - I realize this collateral standard is (always?) applicable. But is a test report really necessary from a regulatory (FDA, NB) standpoint? ...our risk analysis is pretty thorough wrt potential usability issues. And besides, much is covered in -1-11, no?
3. IEC/EN 60601-1-11 (~$6K) - This I'm not sure of. It's applicable, but unlike the usability there are some tests (e.g. environmental) that might be worth biting the bullet and paying for..?

Anyways, as you can see this all adds up to a lot of extra $$. Does anyone have any input as to how to get this costs down?

NOTE: while I realize standards testing is not mandatory per se, the intent here is to make regulatory submissions (in particular FDA, EU) as painless as possible. If, in people's experience, FDA and/or NBs want to explicitly see reports on any of the above when claiming 60601 compliance, do weigh in...

Thanks as always!

 

[tallu]

I don't see 60601-1-6 applicable to be performed by test lab.

We haven't faced any problem to handle and show compliance with the standard. Our own design documentation has been enought - even with the FDA. Usability is part of our design process and its implemented to design, V&V and after sale processes.

If you have accredited 60601-1-11 test report for your product it should raise value if you are seeking FDA clearance.

And what comes to 14971 it is highly included to 60601-1 3ed testing. No additional value.

It feels like your test lab is interested to make money...

 

[Mark Meer]

Thanks tallu.

You are confirming my suspicions.

However, it's not only one lab, it's several. I guess if they see an opportunity for an extra $20K they'll go for it.

So the suggestion is:

- Omit 60601-1-6: instead, just ensure that usability concerns are well documented in design docs.

- Omit ISO 14971: instead, just ensure internally that risk files conform to the standard, as they will be looked at as part of regular 60601-1 testing

- Keep 60601-1-11: as it is good evidence for safety in home environments

Anyone else weigh in?

 

[Pads38]

When considering what to include I think you need to understand what sort of testing you are asking the external lab to perform.

Are you just asking for 60601-1 tests and a test report for that?
or are you hoping that the lab, assuming it is part of the IECEE scheme, can issue a formal CB Certificate?
or even are you hoping to use the testing to apply a 'mark' (UL, ETL etc)?

As 60601-1-6 (and the other 'collateral' standards) are considered to be part of the general (60601-1) standard, and cannot be separated, certification to 60601-1 implies that ALL applicable collaterals have been considered.

And consideration of the Risk Management Process is stated in Clause 4.2 - you will not get certification without it.

 

[Mark Meer]

Are you just asking for 60601-1 tests and a test report for that?
or are you hoping that the lab, assuming it is part of the IECEE scheme, can issue a formal CB Certificate?
or even are you hoping to use the testing to apply a 'mark' (UL, ETL etc)?

Do I have this correct?
- Just test reports: ok to justify exclusion of "test-lab-certified" -1-6, and assess your own usability.
- CB-Scheme, NRTL marks: test-lab-certification required for -1-6.

As 60601-1-6 (and the other 'collateral' standards) are considered to be part of the general (60601-1) standard, and cannot be separated, certification to 60601-1 implies that ALL applicable collaterals have been considered.

In what cases would 60601-1-6 not apply? It seems to me that usability is pretty much applicable in all cases, no? In which case, it's curious that some labs (albeit few) did not include -1-6 in their quotes, and obviously some companies have gone through 60601 certification without test-lab-certified -1-6.

 

[Pads38]

Do I have this correct?
- Just test reports: ok to justify exclusion of "test-lab-certified" -1-6, and assess your own usability.
- CB-Scheme, NRTL marks: test-lab-certification required for -1-6.

I don't think it is absolutely set-in-stone but, yes, I think that is right.
I have seen a CB certificate with lots of excluded sections, including excluding risk, but that was for a power supply module - a component not a finished device.

In what cases would 60601-1-6 not apply? It seems to me that usability is pretty much applicable in all cases, no? In which case, it's curious that some labs (albeit few) did not include -1-6 in their quotes, and obviously some companies have gone through 60601 certification without test-lab-certified -1-6.

I would agree that -1-6 applies in all cases. However -1-8 (Alarms and signals) may not apply at all along with several of the other collaterals (eg -1-10, -1-11).

 

[Peter Selvey]

There no requirement, justification or value in getting third party test reports for IEC 60601-1-6, ISO 14971 or any other management system based standard. Although the CB scheme has a basic rule that all parts (collateral/particulars) must be included, for medical there is a big gaping hole in the system: responsibility, which is a core part of ISO 17025 and ISO 17065, the rules that govern third party labs/certification.

Test labs are charging for these standards but it is only a matter of time before this is exposed as a something of a rort.

A test laboratory can provide value in the regulatory context for areas like electrical safety, as they have expertise, equipment, impartiality and responsibility for the tests and results. If electrical insulation fails, somebody gets hurt, and the cause is found to creepage distance failure, any third party test lab that wrote "Pass" against Clause 8.9 is clearly in the firing line for legal liability. Even the test lab would agree with this, and they normally have insurance for such events. There is also a strong, well established structure which makes such adverse events rare.

In contrast, if an incident is caused by poor usability, a test lab that wrote "Pass" against the clauses of IEC 60601-1-6 is going to walk away and say "it's not my responsibility". If so, why are they charging so much money for it? What are they actually doing?

One could argue that their job is just to check the "form" of the management system fits the standard, not the content. That might be OK if (a) they don't charge very much and (b) the test report clearly states that assessment is limited to form and not content. But $6k way too much just to be checking just form. And if only form is checked, regulatory reviewers will still need to see the manufacturer's assessment for the content, so there really little practical value in the third party test report.

ISO 14971 is also a management system, and one which is widely open to interpretation and discussion even for "form" let alone "content" . Again, the test laboratory is going to take zero responsibility for any incidents in the market even if they issued a "Pass" report, even if they charged $8k for the service.

It might be interesting for someone to quiz the labs to find what, exactly, are they responsible for. If they are charging $6k to $8k they cannot say "no responsibility", but they might eventually admit their responsibility is limited to form, not content. If so, then you can ask them, why does it cost so much to check just "form"?

Not all collaterals are managements systems. IEC 60601-1-8 (alarms), IEC 60601-1-11 (home use equipment) are type-test standards. Like IEC 60601-1, they do have some interface with risk management/essential performance etc, but fundamentally they are type test standards, so there is value in test labs performing the tests, provided of course that the follow the rules in ISO 17025 etc (and not just rubber stamp the manufacturer's tests, as some do ... but that is another story ...)

 

[Mark Meer]

Thanks Peter, I agree 100%.

Trouble is, along the line of what Pads38 points out:
1. Risk file assessment is a part of 60601-1 compliance testing... which costs nearly as much as the "actual" testing.

2. While 60601-1-11 may be by-and-large type-test, it references -1-6, so the thought is that it must be included.

3. Usability is applicable to any device, and because "all applicable collaterals" is required for an NRTL mark signoff on 60601-1 safety, -1-6 has to be thrown in.

(sigh)
Like I say, I'm in full agreement with you that the price-tag to fill check forms is difficult to justify.
Not only that, but as another poster (Evike) mentions in post #10 of this thread, test labs sometimes have their own "risk file template" they want filled out to make their assessment easier.

 

[Peter Selvey]

OHSA's (NRTL) rules specifically state that parts of the standard that are unrelated protection of employees are out of scope of the NRTL scheme.

29 CFR 1910.5(d)
In the event a standard protects on its face a class of persons larger than employees, the standard shall be applicable under this part only to employees and their employment and places of employment.

Patient related safety issues is therefore formally outside of the scope of the NRTL scheme.

Any NRTL that insists that IEC 60601-1-6 is required for an NRTL mark is obviously unaware of this particular point of law in the US.

An NRTL mark is also a private mark so the agency can set their own rules.

Also in some cases the NRTL can argue that it would be irresponsible to exclude parts of a standard, for example, excluding patient from evaluation for electric shock.

But that argument falls down with something like IEC 60601-1-6, or any of the highly specialized functional related testing in the 601 series. Basically the current approach of the test labs is as follows:

1) we have to do it
2) since we have to do it, please give us your files/reports for us to rubber stamp
3) we will charge you a lot for it
4) but we don't take responsibility, because it is outside of our core competence

Items 2 to 4 could be excused if item 1 was true. But it is not.

 

[Mark Meer]

OHSA's (NRTL) rules specifically state that parts of the standard that are unrelated protection of employees are out of scope of the NRTL scheme.
....
Patient related safety issues is therefore formally outside of the scope of the NRTL scheme.

This is assuming the device in question is intended to be operated exclusively by the patient, no?

In cases where healthcare workers use the device, or provide initial setup, fitting etc., wouldn't usability considerations then be in the NRTL scope?