EBME Forums Forums Maintenance Technical Assistance Recording,Storing and Analysing Electrical Safety

In similar vein:- here is a thread (that some may have missed) about recording PM results.

I make the assumption that only accessories that have a serial number are be included as tracking anything else is, as you point out, virtually impossible.


Well it has a BS number, BS EN 62353, so is as sanctioned as anything is!

The MHRA DB2006(05) document calls for records to be maintained and requires electrical safety tests to be performed to comply with the requirements of the HSE and EWR but indicates not to use the type tests of IEC 60601-1!

Therefore that only leaves 62353!


Indeed you have to make a note (in a tick box) of the method employed for the leakage tests.

I have read so much regarding ME electrical safety testing and listened to many experts and there appears little consensus of opinion regarding electrical maintenance testing of Medical Equipment.

Why can’t a simple PAT be applied to ME items? A PAT includes a visual check (most important in my opinion) and an electrical result for each device. Does this not satisfy both HSE and Electricity at Work Act? It seems to me that the only people worrying about IEC 60601, 62353 standards etc, etc are EBME technicians (and the manufacturers of the test equipment) because unless I am very much mistaken no-one else gives a damn.

It's an interesting take the issue, Barney.

But what does a "simple PAT" actually entail?

1) Protective earth resistance
2) Insulation resistance

Sounds kind of familiar!

What current does the PAT guys shove down the earth conductor?

Whilst I take your point about the legalities of the situation, I doubt that a smart lawyer would be swayed by the argument (unfortunately).

The clue is "medical equipment". Which, as we all know only too well, has a whole box of safety standards all of its own. Which is just how it should be, in my opinion.

Perhaps (with all this talk of PE, testing currents and the like) you're forgetting, what for me is the more interesting point, namely:- leakage current(s)!

If I was on "Desert Island Discs", and could take only one test with me, it would have to be this one:-

Enclosure leakage. If that one shows less than *100 µA with the earth both open (1) circuit and then closed (2), then all must be well.

1) Represents the "worse case" (or Risk Current) that could flow through someone grabbing hold of the kit when the earth is faulty (missing).
2) If less than (1) - as it should be, and if you can actually measure it - proves that there is an "earth".

* The limit is 500 µA with the earth lifted, of course.

I totally agree Geoff ME should be tested at a medical standard(especially regarding leakage currents), but other than EBME technicians or manufacturers who cares?

Three weeks ago I spent much time commissioning a large amount of equipment and PPMing existing equipment in a newly built hospital. Today I returned only to be greeted by the sight of Joe Pattester labels covering my (in date)labels on ECG, BP, Defib machines etc etc. This sorry waste of our Taxes really annoys me. I flag it up to line managers, matrons and bore the nursing staff with the fact that they are paying for my medical electrical test as well as Joe Pattester's but all falls on deaf ears. The same occurs at Doctors' Surgeries year after year, no one understands and no one cares. "You're getting paid and so is Joe, so why worry?" appears to be the attitude. Surely if a standard for medical electrical equipment is far more exacting than that for a portable fan or hairdrier then an appropriate test should be applied that is mandatory?

However as far as I understand all that is required is a PAT. If anyone can refer me to any literature that says differently I would be grateful for the reference.

Dare I mention IEC-62353 (and its British Standard equivalent)? Or, if you like, the famous DB-2006(05) (vague* though it undoubtedly is).

I hear what you're saying there, Barney, having been through similar experiences myself.

But when it comes to the question "who cares"? I usually say something like:- "Yes, who cares what they think"?

In other words (and as I have said many, many times over the years) someone has to give a [censored] about it all, so it may as well be us! To be honest, there isn't anyone else.

* Talking about stuff like "...a general duty to take necessary steps to protect staff from danger...". Yes, yes - but what about the patients?

I (again)agree with you, however a Pratice Manager at a Surgery has to get their equipment electrically tested and all they need to claim some brownie points is a PASSED ELECTRICAL SAFETY TEST label on the equipment and the fancy certificate. At present the only requirement is for portable electrical equipment to meet the specification of the Portable Appliance Test, class 1, 2 and occasionally 3, with no consideration of the further medical classes B, BF, or CF. I argue that a piece of medical equipment should not have a label stating PASSED ELECTRICAL SAFETY TEST unless it has indeed been tested to an approved standard such as IEC 62353 as do most EBME technicians but it appears we are in somewhat of a minority due to no one in authority caring.

I agree with you Mate. Any properly designed electrical safety sticker (medical or otherwise) should make it clear which standard the thing was tested to, should it not?

Meanwhile, as we that dwell in Britain know only too well ... the law can be (and often is) an ass! We have laws that prohibit all sorts of [censored], not to mention infringements on our so-called rights and freedoms, but stuff that actually matters often just gets left to be covered (if at all) by "guidelines" and weak BS like that!

Not only that, but those who are supposedly paid to enforce those laws are, shall we say, a bit picky about which ones actually get enforced.

But, as I say, let the common herd do as they may ... my own conscience remains clear enough.

In practical terms (that is, for testing purposes), what is the maximum number of Applied Parts that anyone can remember coming across?

Most Electrical Safety Testers seem to expect up to ten (usually marked to indicate the connections of the 12-lead ECG). One that I know of only has five AP sockets, whilst another allows up to 14 when using an adaptor.

In case anyone is wondering (?), I'm interested in this as I want to set a sensible maximum number in a database.

It depends if you are only testing to 62353 or intend to perform testing to 60601-1? Since if using 62353 all applied parts of the same function are connected together this generally limits the number of tests. So for example on an ultrasound machine you may have a 5-lead CF ECG, 4 transducers of BF and 2 transducers of CF so would need to record only three values. Even if you tested the transducers separately you would only need one applied part entry for each probe.