Are you struggling with your IEC 60601-1 3rd edition testing lab?

[Sarah Stec]

Hello everyone! I'm just wondering what issues, if any, that you've had with your testing lab when testing your devices to IEC 60601-1 3rd edition? For example, is the testing too expensive? Does it take too long? Are there not enough labs in your area with sufficient expertise for the standard/your device? Anything else?

Or, are you perfectly happy with your lab (because that happens too!)?

I'm doing a small study on people's opinions on their 3rd edition testing labs, so whatever information you're willing/able to give, I'm happy to have. Thanks in advance!

Full Disclosure: As you can see, I work for a Notified body. But, in accordance with the Elsmar rules, I promise that this is just to get information and not to advertise!

 

[isoalchemist]

Yes, the testing is expensive and time consuming. We have already switched labs once because of poor communications with them as to expectations.

Being new to this type of certification, I found it difficult to understand the requirements and speaking with the laboratories at times they have had problems understanding how the NB want thing interpreted.

it does present a challenge especially to the small manufacturers.

 

[Ronen E]

Hi Sarah,

I bet $100 you can't find 1 medical device manufacturer who doesn't think their 60601 testing is too expensive and too lengthy

If you search Elsmar Cove for "60601" you'll find some "supporting evidence".

Have a great day,
Ronen.

 

[Sarah Stec]

I had already run a search, so I don't think I'll take your bet. Rather, I was hoping to get a bit more specific feedback. As an example that would never happen, "The lab is too expensive because they insist on using their diamond-and precious-stone-encrusted equipment, etc."

Communication issues, and not adequately communication the testing requirements, is another example (Thank you, isoalchemist!).

 

[ssz102]

i don't think so
the cost of test is expensive, because labor and time cost are all raise, and the need is too large, meanwhile, the compete between business is more and more stronger

 

[Waterman956]

Sarah,

Yes we have a lot of trouble with our testing lab. The initial cost was very expensive and the resource burden even more so. We are a low risk device manufacturer yet the amount of information requested is staggering. I am also bothered that the lab seems very rigid in their interpretation of how to implement the standard. Reminds me of when ISO 9000 came along in the early 90's and people including registrars were confused on how to implement.

I am planning a face to face meeting with the lab to try and iron things out. This is the first of a very large number of products we need to push through and frankly we can not afford the financial and resource draw if they are all like this.

 

[Peter Selvey]

I think the implication here that test labs are bad is perhaps a bit misdirected.

The 3rd edition is a standard which, in polite terms, is suffering a multitude of teething problems.

I myself have had many occasions of staring at the test protocol, cursor blinking, trying to decide whether to go back to the manufacturer and try explain why their response doesn't match what is written in the standard, for a subject that zero impact on the real world, or whether to give up and just write "Pass", in effect falsifying records, and throwing away the principle of third party, impartial, laboratory evaluation.

The true guilty party here is the team that wrote the standard: don't shoot the messenger.

On a more serious note, we do need to look at the process of standard development and in particular methods to validate the need for each requirement, the ability to objectively evaluate compliance, and to eliminate as far possible errors before publication.

In a commercial, competitive world standards play an incredibly important role in avoiding the race to the "lowest common denominator", so I have no doubt that standards will continue to play an important role in the future. But we need to get better and smarter about how standards are made.

 

[Pads38]

We are in the fortunate position that in-house testing for our products is accepted by our Notified Body and most of our customers and potential customers. Our products are "niche" devices and there is no way that a commercial test house or CB test is justifiable.

We have developed the in-house procedure without a great deal of difficulty. We found that many of he more complex requirements do not apply for our products and many other tests can be tackled with simple equipment. Going through all the requirements has meant that we have directly addressed every one of the "..by examination of the Risk Management File.." clauses.

I would suggest that other manufacturers could benefit from in-house testing. Even if that was not allowable for your intended market it means that you have a much better understanding of both the test requirements and of your own equipment. Then, when your test house comes back with a problem / question you will be much more likely to have an answer or counter-argument.

 

[Sarah Stec]

Thank you everyone! Anyone else?

 

[Evike]

Dear Sarah

You have posted your question more than a year ago, so my reply might not interest you anymore, but it looks like you are logged in today, so here is my opportunity to went :mg:

I'm a regulatory affairs person for a small Canadian medical device manufacturer, and I'm in this field for more than 15 years. I've never felt this much frustration doing my job EVER!

We are developing a class II low risk device and currently seeking the 4th quote for the 60601-1 3rd edition testing - trying every lab in the Toronto area.
The best quote so far (after weeks of haggling) is $41,000.00 !!! In my previous job (in the era of 2nd edition) a very-very similar device's testing used to cost 5-$6000.00, they are in the market place for years and they proved to be safe. The 3rd edition introduces a level of requirements that is bordering paranoia frankly, but more to the point is a very blunt instrument with very little room to distinguish between real safety concerns. Is it an MRI machine or a blood pressure monitor? Doesn't matter, let's go through all 396 pages plus collaterals. And the testing labs taking advantage of this aspect.

Here are my real-life experiences and the factors contributing to my extreme frustration:
- every testing lab is avoiding to give you even a tentative quote, before extensive checklists and component details - they have to know your device, fair enough; yet after all the details we give, they come up with set prices, especially for collateral standards, all of a sudden totally ignoring the specifics of the device. Case in point: I've pointed out to one of them, that form 45 clauses in a collateral standard 20 is not applicable to my device, 5 are a repeat from another collateral, 14 requires a simple inspection of the labeling and ONLY 4 requires them to execute technical testing requiring their laboratory settings. It doesn't matter the price is stuck at $8000.00
- the checklists for Risk Management the labs are giving out are all different, some are outdated (the latest lab asked me to fill out a table running on 31 pages which was based on the 60601-1 TRF (test report form) version G (when in fact is version H is now in effect) based on ISO 14971:2000 not matching the latest ISO 14971:2007 which is the harmonized standard by now
- these RM checklists are de facto doing most of the labs' job to review my Risk Management, yet for this item alone I get quoted 7-$8000.00
- in order to facilitate the labs job of risk management review, our Risk Management Report morphed into a monster document, becoming unreadable, full of NA's, and addressing issues which for all practical purposes don't have anything to do with the actual device, but is a clause in 60601-1
- our device has an inert USB powered "dummy" hardware component with the real brain (and innovative aspects) incorporated in the software part; 60601-1 has 5 pages on the subject (clause 14 PEMS), delegating this whole issue to other standards (life cycle, architectural design, software verification, etc), testing labs having precious little to do with any of it, yet THIS IS MY DEVICE!

And then the finale: when I face my Notifying Body, my risk management will be scrutinized thoroughly AGAIN - this time on it's merit (I have been there, I know), namely the software development cycle, software testing, requirements traceability, usability, etc; great focus will be on clinical validation. The "Colours of the insulation of conductors" or the outcome of a push-test will be absolutely non-essential and not touched-upon with good reason.
So why the biggest cost-item (bordering prohibitive) in our regulatory budget is the 60601-1 3rd edition testing??

After 15+ years in the medical device industry I always felt that the regulatory burden is too big to bolster innovation, but the 60601-1 3rd edition is a down-right killer. No sane inventor with ideas for smart high-tech consumer oriented medical devices to better our healthcare outcomes will step in this sector.

Sorry for the long post - you asked for it