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IEC 62353 #69256
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umish Offline OP
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Could anyone please clarify is IEC 62353 accepted for use in the UK?


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Re: IEC 62353 [Re: umish] #69257
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Yes it is certainly accepted for use when routine testing and for testing after repair in the UK. However, this is not to imply that it is in anyway mandatory.

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Re: IEC 62353 [Re: Barney] #69258
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And, as BS EN 62353:2008, it gets an honourable mention in recent "guidance" from the MHRA ("Managing Medical Devices" - April 2014). smile

Re: IEC 62353 [Re: umish] #69259
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Although there were some minor objections in the national forward of the 2008 version of BS EN 62353 these have now been resolved as indicated in the national forward of the 2014 version:

Quote:
This British Standard is the UK implementation of EN 62353:2014. It is identical to IEC 62353:2014. It supersedes BS EN 62353:2008, which will be withdrawn on 9 October 2017.

The UK committee voted against the first edition of this standard, however, the issues raised previously have now been resolved in this edition.

It is not only advisable to use this standard for testing, as it is the only official standard, but can save lots of time, especially if the Alternative leakage current test methods are used.

Re: IEC 62353 [Re: Barney] #69260
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Originally Posted By: Barney
Yes it is certainly accepted for use when routine testing and for testing after repair in the UK. However, this is not to imply that it is in anyway mandatory.
BS EN 62353 is also good for tests before putting devices into service. From section 4.1:

– tests before PUTTING INTO SERVICE,
– RECURRENT TESTS, and
– tests after REPAIR.

Re: IEC 62353 [Re: MikeX] #69261
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Yes; I think we can all agree that 62353 is the Standard that everyone should be using these days.

But out of interest, Mike ... do you have any idea about what those earlier UK objections were? Something nebulous ... or something of real (practical) substance? think

Re: IEC 62353 [Re: Geoff Hannis] #69263
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Originally Posted By: Geoff Hannis

But out of interest, Mike ... do you have any idea about what those earlier UK objections were? Something nebulous ... or something of real (practical) substance? think

In my view they were unjustified objections largely based on a misunderstanding of the Alternative leakage method and a wish to carry on using 60601 tests. Actually everything is now possible according to the latest 62353 but I would urge all those performing EST to consider switching to 62353 and mainly use the Alternative methods. No need for DC insulation testing either! So on a class I device only three electrical tests, Protective Earth Resistance, Alternative Equipment Leakage, Alternative Applied Parts Leakage. No need to power up (boot) the device and no need to do any mains reversal. Quick, reliable and easy!

Re: IEC 62353 [Re: MikeX] #69264
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I can well imagine that the Alternative Method is not easily understood (and I wonder how instructors on electrical safety courses get on in that regard).

In fact some may even go as far as to suggest that it's a bit of a "fudge"! whistle

Although I can see the attraction to using the Alternative Method (in short:- "quick and easy"), I would argue myself that it doesn't actually measure leakage currents at all, but rather estimates (and usually an over-estimation at that) what they might be!

Biomeds of the type who prefer things like EST to be Step 1), Step 2) etc. (that is, simplified) may not be too happy about having to choose between the three approaches ("Methods") that 62353 supports - and my guess is that the (more traditional) Direct Method is the one most techs will be following (as it is easily understood, and "follows on" from what folk have been used to - in other words, 60601).

Lastly, it is my understanding (?) that in cases where the Alternative Method indicates currents around the edges of acceptable limits (or above them), then 62353 suggests using another Method (eg, Direct) to confirm them!!

Maybe we need a Poll (and we haven't seen one in a while) to find out what the various Departments are doing when it comes to 62353. smile

BTW: have the Standards Committee(s) made up their mind yet about what the Protective Earth Test Current should be? think

Re: IEC 62353 [Re: Geoff Hannis] #69269
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Originally Posted By: Geoff Hannis

I would argue myself that it doesn't actually measure leakage currents at all, but rather estimates (and usually an over-estimation at that) what they might be!
No, it measures the leakage currents very accurately! But you have to understand the reason for the higher values than when using the Direct test method. Essentially the Alternative test is the same as performing an open neutral 60601 Direct leakage measurement, when it is normal to expect about twice the standard leakage current. Remember in a normal Direct test we have a T-NS mains supply in which the Neutral is referenced (connected) to Earth. Therefore generally half the capacitance that makes up the leakage currents have no potential across them, whereas when the Neutral is open the full mains supply is presented to all these capacitances. This is why both the open neutral 60601 tests and 62353 Alternative method allow twice the leakage values (1mA instead of 0.5mA).

The reason 62353 mentions you have to measure using another method if the measured Alternative method exceeds 1mA (or 2mA for mobile X-ray units) is this indicates the earth leakage leakage current may be at the 60601-1:2005 5mA level so this requires the touch leakage to be measured to ensure it is below 0.5mA.

From 62353: If the value of the alternative method exceeds 1 mA, either the direct method or measurement of the TOUCH CURRENT shall be applied (allowable values in Table 3).

One you switch to using the Alternative method and have reference values, as you need for all 62353 tests anyway, you can rest easy in the knowledge you have performed adequate safety tests to meet any legal obligations and saved time and money in the process!

As for your last point the choice of protective conductor test current is up to you, anywhere between 200mA and 25A. But it is generally accepted the lower figure is the one least likely to cause damage if an incorrect point is touched and therefore would be my choice every time. Better a false failure due to an oxidised contact than generating a potential fault by using 25A!

Re: IEC 62353 [Re: MikeX] #69270
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Accurately measured, maybe; but how can they be the true (actual, real world, "as they would be in use") leakage currents if the kit being tested is not energised by the mains? think

Don't get me wrong, I'm a supporter of 62353 in general, but I can't help but think that it's a bit of a "missed opportunity". In short, there's probably too much "mix 'n' match" (or "take your pick") in there for many of the biomeds I have come across; most of whom seemed to prefer a "this is what you do" approach. frown

I cite your final revelation as an example ... so, even after forty-odd years of EST Standards, we still can't agree on the test current. Let's plumb for 10 Amps and be done with it! smile

Perhaps next time around we can get the Committee(s) to consider a "62353-Lite" ... one that ditches the possible confusion (complications) of the Alternative and Differential* Methods, and declares what the PEC test current should be.

* When would (could) you use it? It's "quick and easy", and measures total leakage current - but can't accurately measure low values of leakage (which is, after all, what we're hoping for)!

Re: IEC 62353 [Re: MikeX] #69271
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Mike suggets "So on a class I device only three electrical tests, Protective Earth Resistance, Alternative Equipment Leakage, Alternative Applied Parts Leakage. No need to power up (boot) the device". In all the years I have done electrical safety testing we have always been instructed to have the unit under test powered ON when carrying out an electrical safety test. Is it now standard practice guided by IEC62353 that this is no longer a requirement?

Re: IEC 62353 [Re: kit] #69272
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Only if you (or your boss, Department, company, organisation etc.) elect to use the Alternative Method.

I can only wonder if all this choice (about which Method to go for) is just going to end up with different hospitals adopting different procedures. As far as I'm concerned, the "jury's still out" as to whether this is really "progress". whistle

Here's a question:- do the three 62353 test Methods have equal value? Or are some Methods "better" than others? think

And lastly (as I have mentioned before), I see a need now to always record (on the test sheet, in the database and WHY) which Method was used. Note that 62353 calls for measurement results (and the Method used) to be documented anyway; the Standard calls these the "Reference Value".

Re: IEC 62353 [Re: umish] #69273
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If you do not power on a device you are only testing as far as the on/off switch. For example, if the live after the switch was attached to a patient lead you would get no applied part leakage so the equipment would pass the test. But I would not fancy getting attached to a piece of equipment where the applied part becomes live as soon as you turn it on.
To my mind testing equipment without powering it on is a nonsense.
Robert


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Re: IEC 62353 [Re: RoJo] #69276
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Mike's not going to be happy with that, Robert! frown



What if you switch on ... but still haven't plugged into the mains? Wouldn't you then be testing as Mike described a couple of days ago?

(BTW: for the "purposes of debate", I'm just playing Devil's Advocate here; I have no particular axe to grind apart from a preference for simplicity, common sense, practical, valid, purposeful, and "real world" testing of the kit)!

Re: IEC 62353 [Re: umish] #69279
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I can see the logic in Rojos point, and in practice I see large differences in leakage current measurements between the device being powered off and on, personally I would think it pointless measuring leakage currents from a device that is not powered on. The interesting thing is, there is still many differences of opinion in interpretation from highly experienced technicians on how to routinely test electro-medical devices. Why should this be the case after all these years, personally Ive given up trying to figure it out as it seems to be a matter of opinion depending on where you work.

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Re: IEC 62353 [Re: kit] #69282
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Originally Posted By: kit

... in practice I see large differences in leakage current measurements between the device being powered off and on


Yes ... but that would be using the Direct Method (or a 60601 testing regime), I should imagine.

Maybe the best "way forward" is to adopt 62353, but (for the time being at least) stick to the Direct Method of measuring leakage current.

Regarding your second point:- yes, I agree. smile

Re: IEC 62353 [Re: umish] #69283
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Geoff, I honestly had not heard of this alternative method. I am even afraid to ask what it is as I can imagine there is another wave of confusion coming my way. The only saving grace is I know Im not alone, having asked another 3 experienced techs if they know what this alternative method is, I was met with 3 blank expressions.

Re: IEC 62353 [Re: kit] #69284
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OK, but 62353 has been around for a number of years now.

Although (as mentioned before) my aim here is simply to "continue the discussion" (and I believe it is one that needs to be discussed), I do wonder why the committees of electrical safety Grandees felt the need to introduce the extra (both the Alternative and Differential) testing methods. Where did the "push" come from? Certainly not from the "shop floor", as far as I can tell. frown

On the other hand, the Alternative method may be useful for testing PC-based kit (not energised [no "boot-up"]) such as ultrasound units, lab analyzers and er, PC's; whilst the and Differential method may be useful for "heavy current" kit such as mobile x-ray units and so forth.

I have linked to this article by John Backes before. It gives a good precis of the stuff we have been discussing. It is a bit old now, so if anyone can link to a better one, feel free to go ahead! smile

This .pdf also offers some clues about which Method to apply.

Quote:

... selection of which should be based on the design of the device


Re: IEC 62353 [Re: umish] #69285
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Oh yes, dont get wrong Geoff, I am aware of the existence of 62353 and I recall our department was given a talk about this when it initially came out about 8 years ago. But after intial discussions and then waiting on definitive changes to our Procedures it seemed to fall by the wayside, so no one in our dept has changed their method of electrical safety testing. Ive had a quick look online and I see what you mean about the different methods, direct, differential and alternative, but alas it is not even on the radar among the techs in our dept.

Re: IEC 62353 [Re: kit] #69286
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I believe (hope?) that manufacturers' documentation and (or) service manuals should clearly declare which 62353 testing Method is appropriate and recommended for each piece of equipment ...

... failing that, it would be nice if some Learned Fellow came up with such a list to cover typical examples of equipment normally encountered in hospitals these days. smile

Re: IEC 62353 [Re: umish] #69288
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I get the impression that many who are performing medical electrical safety tests like to speed a long time doing these tests! If you use typical 60601 tests on a PC based ultrasound with ECG and say 5 probes with a typical boot up/down of 10 to 15 mins then you could easily spend a few hours performing the tests.

Using 62353 Alternative methods, assuming you had ensured the power switch is in the on position, it would take about 5 mins to do the tests and then just the time it takes to boot up and perform a function test (as required by 62353) and your done.

Many manufactures are now updating their service material to 62353 and often choose the Alternative method for speed and safety. I know Siemens have recently updated their Ultrasound product electrical safety service instructions to 62353 and have adopted the Alternative method.

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My own suspicions are that the folk we have been hearing from don't get around to carrying out EST on ultrasound systems very often! whistle

As an aside, I wonder why 62353 explictly includes the requirement that a functional test be carried out? Myself, I have always considered EST to be part of PM (and not the other way around). smile

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Quote:
What if you switch on ... but still haven't plugged into the mains?

An electrical safety test with no electricity involved what a perfect way to make sure everything passes and is "safe". think

As to the matter of time....a good ES tester should be able to power the device on, then when it has booted you then start the tests in normal polarity. you then power it down, reverse polarity, boot the device and do the tests again. I was using a tester that did this well over 10years ago..... and what device takes 10minutes to boot? No modern stuff surely.
But yes there is plenty of old stuff around still.
But surely EST is about making sure the device is safe rather than cutting corners to tick the "I have done it" box in as short a time as possible.
Robert


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Re: IEC 62353 [Re: RoJo] #69302
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Can we take it that you're not a great fan of 62353 then, Robert? whistle

Re: IEC 62353 [Re: RoJo] #69305
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Originally Posted By: RoJo
An electrical safety test with no electricity involved what a perfect way to make sure everything passes and is "safe". think

Well, if you read IEC 62353 you would know the Alternative method tests apply an AC voltage equal to the mains voltage to perform the test. So we do indeed have electricity involved!

Think of it as a souped up insulation test, except you never get the same reading (infinity) with the DUT either plugged into the test meter or not! You get a accurate representation of the true device leakage, which is directly related to the 60601-1 open neutral value.

Also not many test meters I know can switch from performing equipment leakage tests to applied parts leakage tests without interrupting the mains supply to the EUT.

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Three years on ... does anyone have an up to date list of which testers are now available to carry out tests to 62353?

I'm thinking of portable types able to follow the Alternative Method.

Are any completely battery powered? smile

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Wouldn't a Rigel/Seaward 288 do the job Geoff?

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Indeed it would (does) ... but what about the others? think

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I think Fluke manufacture a few various devices Geoff, but it does state ' Tests Parts of IEC 62353 & 60601 '. We only use 288's though so I can't really comment on these shrug

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As far as I can see these are the currently available units:

Rigel (Seaward) 288+ (IEC 60601 & IEC 62353 Including Applied Parts)
Rigel (Seaward) 62353+ (IEC 60601 & IEC 62353 Including Applied Parts)
Rigel (Seaward) SafeTest 60 (IEC 60601 & IEC 62353)

Fluke ESA 609 (IEC 60601 & IEC 62353 but no Alternative method)
Fluke ESA 612 (IEC 60601 & IEC 62353 Including Applied Parts)
Fluke ESA 615 (IEC 60601 & IEC 62353 Including Applied Parts)
Fluke ESA 620 (IEC 60601 & IEC 62353 Including Applied Parts)

GOSSEN METRAWATT SECULIFE SR ( IEC 62353)
GOSSEN METRAWATT SECULIFE SB (IEC 60601 & IEC 62353 Including Applied Parts)
GOSSEN METRAWATT SECULIFE ST (IEC 60601 & IEC 62353 Including Applied Parts)

Bender UNIMET 300ST (IEC 62353)
Bender UNIMET 400ST (IEC 62353 Including Applied Parts)
Bender UNIMET 810ST (IEC 60601 & IEC 62353 Including Applied Parts)

BENNING ST 750 A (IEC 62353 Including Applied Parts - EU Plug only)

DATATREND Systems Inc vPad-Mini (IEC 60601 & IEC 62353 Including Applied Parts)
DATATREND Systems Inc vPad-Rugged 2 (IEC 60601 & IEC 62353 Including Applied Parts)
DATATREND Systems Inc vPad-ES 2 (IEC 60601 & IEC 62353 Including Applied Parts)

Clearly the Rigel (Seaward) and Fluke units are the most popular units.

I would never recommend purchasing any unit that could not perform the IEC 62353 Alternative Method, since this not only saves a lot of time but many manufactures now show this as the only method to use in their service documentation.

Anyone who is sceptical the Alternative test is not as safe or effective as the Direct or Differential methods should conduct a few tests of their own and compare values. In all cases you will see the Alternative will be about double the Direct or Differential method proving it is effective. Clearly at the end of all testing a functional test is required by IEC 62353 but this is always when the unit is not going to have any further tests or work performed on the device. I.e. confirming it is ready for return to the user.

Last edited by MikeX; . Reason: Added Benning & Datatrend units
Re: IEC 62353 [Re: MikeX] #73179
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That's good information Mike ... thanks for posting it. smile

Are any of them battery powered? think

I was also wondering about BC Group (I like their kit); but I don't see any mention of 62353 there. frown

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I don’t like most of the BC Group products as they only perform the protective conductor resistance test using 10mA. The minimum for many standards, like 62353, is 200mA. I see they do one model that is a re-badged Gossen Metrawatt device, so assume this will cover 62353.

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Yes; well spotted. I believe that many BC items are re-badged from OEMs. I suspect Dale in the case of the "10 mA" testers you mention. But their range overall is more or less complete, and their catalogue is very good.

I assume that the Gossen Metrawatt is the SA-2500. The manual for that one does indeed mention 62353 (and VDE 0751-1), as it does the "Alternative Measurement Method". As well as a 200 mA PE test current.

Meanwhile, here is a handy source of BC User Manuals. smile

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Another meter you can add to the list is the Metrel MI 3360 M. (Must have the M designation so it includes the IEC 62353 tests). Also the GMW TG euro 1 med and the Gossen Metrawatt Secutest Pro (M7050-V003) can perform IEC 62353 testing including applied parts. I see the GMC Secutest Pro is also listed on the RS website.

Also to answer the original posters question, IEC 62353 (BS EN 62353) should be used in the UK as mentioned in the MHRA Managing Medical Devices (2015) publication. This states not to use 60601-1 tests (page 22) and to use 62353 (page 24).

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Originally Posted by MikeX

Must have the M designation so it includes the IEC 62353 tests


M for Medical? think

And yes; that Secutest Pro really looks "the business"! smile


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