An ongoing EMC test in accordance with IEC/EN 60601-2-47 EMC

C

CreMindES

#1
I'm a newbie on the field of medical standards, and I have a little confusion about an ongoing EMC test.

The product is an ECG Holter, marketed in manly in EU and Japan, and a member of the test facility wrote that he's certificating our product according to EN 60601-1-2:2007 and EN 80601-2-47:2010.

Well I haven't found EN 80601-2-47:2010. But we used EN 60601-2-47:2001, which we think we need as it is about ambulant products. Was it a typo? (I will contact with him, I just want to make sure before asking stupid questions)

The second confusion point is the same standard, the EN 60601-2-47:2001 - which I think is valid today - is referring to IEC 60601-1-2:1993. But there are newer versions of the latter (we use EN 60601-1-2:2007), and the points are not perfectly matching. It's kinda strange for me... I've searched around a lot, and found that there is a new version of the IEC 60601-2-47, published in february 2012. As far as I know, the harmonization of this standard is undergoing now by the EU and CENELEC.

My question and asks are:
- Was I correct in the aboves - dates, valid standards, etc?
- Should we use the IEC 60601-2-47:2012 or the EN 60601-2-47:2001?
- Can you give me some clarification about all this to see clear?

Thank you for your help, it's really appreciated as I'm quite new to the world of medical standards!

p.s. It's kinda interesting too, that an ambulant holter, which is recording 24h ECG signal usully, have to confirm such strict standard, particuraly 3V/m 80-1000MHz /according to 60601-2-47:2001/ without significant distortision in (such a low voltage) signal /according to 60601-1-2)/. I mean, if the user doesn't keep the 2,5 meter distance in case of a cell phone (3V/m) or crossing an EMI source and the recorder losses 30 minutes maximum, there will be 23,5 hours of good measurement. Of course we are designing to pass it easily (as a user won't keep that distance) but it looks a little bit to strick at first glance.
 
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Elsmar Forum Sponsor
#2
Re: Iec/en 60601-2-47 emc

The new version of -2-47 (which as you say was published by IEC in Feb of this year) is edition 2 and replaces the 2001 edition 1. So, at a guess, the reference to a 2010 version is a typo by your test house.

It will take some time for the IEC version to become the EN version; I can't see any mention of it as a "work package" at CENELEC, who do this part of the process. Once it becomes an EN standard it can then be listed in the Eurpoean "Official Journal" to become a harmonized standard that is fully accepted as satisfying all the essential requirements of the European medical device directive.

However - the new version of -2-47 aligns with Edition 3 of the base standard (60601-1) and 60601-1-2:2007. As such it will contain details of the "Essential Performance" required of your device during the EMC tests. It will contain details of how the tests are to be applied and how much distortion or lost signal is to be allowed. As such, I would suggest that it would be very useful to the application of the tests.

I would use the new standard. It also allows some "future proofing". If your Notified Body auditor raised any objection to using a "not EN" standard I would provide a comparison table showing the test requirements from each version, and how the new tests are more rigorous and cover more requirements than the old version (it is unlikely that they would be easier!).

Oh - and welcome to the forums!
 
C

CreMindES

#3
Re: Iec/en 60601-2-47 emc

First of all, thanks for your detailed answer, it was really helpful. It's good to know that there are place and people like you who you can turn to for help in such cases! :)

As my company doesn't have the new IEC 60601-2-47:2012 version, may I ask you to explain what does it mean by "future proofing"? (as currently we are applying some shielding on our device - as it is an older product, where EMC was mostly out of the designer's scope - to be able to meet the immunity requirements)
 
#4
Re: Iec/en 60601-2-47 emc

My apologies if my use of jargon has made my answer less clear.

I have not seen either version of -2-47 but I would expect that the new version has more requirements and that existing ones are more stringent. If you work to these new requirements then, in 3 or 4 years when the new version of the standard is the only one allowed, you would not have to update your design.
 
C

CreMindES

#5
Re: Iec/en 60601-2-47 emc

Sorry for my misunderstanding. The mentioned product wasn't designed according to every aspect of EMC unfortunately. That's why I wanted to clear up things regarding how much effort should we take into this hardware revision.

Of course, our focus will be on the new version when developing new products, it will be a good challenge I think :)

Thank you for all your help, it was really helpful! Have a nice day!
 
B

billarcher

#6
Re: Iec/en 60601-2-47 emc

Hi Pads38
I apologise in advance for this verbose query but I am at my wits end!

I’m QM for a product that has been in the market since early 2007 (via three different owner companies) that has undergone regular Tech File audits with two of the UK’s top NB’s in that period. The first three audits were done by one of the UK’s largest over 4 years and then the owners decided they wanted to change to another company, which was fine. The new NB also carried out the Tech File audit to their satisfaction but stopped offering FDA registration for future development, so I suggested to my new boss that they go back to the former NB which they did.

When we had our Tech File audit recently by the original NB (nothing at all has changed on the product in any way), we had a Trainee Auditor (who had been with them two years) examining our files, who in turn was being monitored by an Assessor.

To our complete surprise one of the NCs they came up with was (and I quote exactly):

Non-Conformity:
“Relevant test reports were not available to demonstrate compliance with Essential Requirements
Requirement (Annex V, Section 3.2d):
“Application of the quality system must ensure that the products conform to the provisions of this Directive which apply to them…the appropriate tests and trials to be carried out before…manufacture…”
Objective Evidence:
“The following test reports were not available: 60601-1, 60601-2-10 to demonstrate compliance with the following essential requirements: 7.1, 7.5, 7.6, 9.2, 9.3 , 11.1, 11.3, 12.6, 12.7, 12.8”

We did have EMC report done by an EMC Test house, costing ?440 (which had been approved by them as well as the other NB several times) which the NB said was not acceptable as it was done by a University Testing Facility rather than an Accredited Test House. So we looked up ACH’s on the appropriate sites and asked for quotes.

These quotes came back at rates between ?8,250 and ?16,700 which was utterly ridiculous and when we asked for justification, verification and validation of these outrageous prices, we were met with comments like: “that’s what it costs us to cover our overheads” and so on…totally perplexing to say the least.

So, in desperation, I showed the Assessment Report to another NB representative for comment and here’s what I got back, which destroyed my faith in both the NB and the ACHs to be honest:

“What I’m saying is your NB’s report is extremely vague in defining what your missing regards to tests.

Just pointing to the ER’s is not helpful, for you the client, or any other assessor.

However you only need to demonstrate that you meet the ER’s, you do-not need to demonstrate you comply with a standard.

If you go through the ER’s

7.1 = biocompatibility
7.5 = phthalates ?

The first two are from you biocompatibility data, not a test house

7.6 = ingress of substances into the device
9.2 = Ergonomics, electrical influences, interference
11.1 = protection from radiation
11.3 = unintended radiation
12.6 = electric shocks
12.7 = protection against mechanical and thermal risks
12.8 = energy supply risk

These 7 are what you need to provide test results for.

For completing the relevant tests to show that the product meets the Essential Requirements I would suggest that the “test house” restrict the testing to these requirements and not complete a full set of tests against the standards mentioned, as this would dramatically and needlessly increase your costs without any benefit.”

So, here’s my problem: I have been totally unable to get ANY of these test houses to give a quote for what we need to cover the above – they all say we should have the full test programmes done which is clearly not true!

Does you know an Accredited Test House that will provide the service we require as indicated by the NB advisor above? Any help will be hugely appreciated!
Regards
Bill
 
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