EBME Forums Forums Maintenance Technical Assistance 62353:2008 - Medical electrical equipment.

Don't worry, I doubt that it's a choice that people have to make every day!

My only worry is that there are those who don't want to see the benefits of this agreed standard put into practice and therefore create a less safe environment.

It would be nice to see all those who service or install medical electrical equipment have to undergo a mandatory training course to certify their competence, in much the same way as electricians have to do in order to perform their work. I am not allowed to install a few mains sockets in my new extension but there is nothing to stop a Part P trained electrician servicing or installing any medical device!

Hopefully more will see the light and embrace 62353 for the breath of fresh air it is.

It is always good to see those benefits you can derived from a new standard but do see those disadvantages as well. Since this is a Bristish Standard, I would assume all over UK, the hospitals are embracing it. So do you put your IEC60601-1 tester aside to make way for the new tester?

IEC60601-1 has been around for years and would definitely not disappear from the eyes of the biomed even though we know this standard is for in-service and post repair!

I believe it takes time for people to win over the standard and start using it though IEC60601-1 is still useable in the biomed's context.

Hi Roger
How's life in Singapore? Please note 62353 is an internationally accepted standard that can be used in Singapore as much as anywhere else. There is no other standard that is such widely accepted for routine testing of medical devices. You'll see one of the leading hospitals in Singapore test to this standard soon. Although IEC 60601 has been around for decades, you'll find little guidance in the standard dealing with your circumstances ie routine testing (and PPM) Thus the tests you are doing are simply ones interpretation of IEC 60601. Do you do the Hipot test at 1500V and 4000 V as well? Do you carry out earthbond at 25A for 10-30 secs and wait for all connections to heat up and perhaps to fuse? Do you carry around an isolation transformer with you so all testing is done at isolated supply (and at 110% of mains)? Do you apply 230V on the communication ports and check for patient leakage? Do you test in a temp / humidity controlled environment (you probably do but not many people do)?
This is what IEC 60601 is about... type testing and making sure the design is safe. People mainly "pick and mix" (see earlier posts)from the 60601 standard and claim they test to IEC 60601. The problem is, you can walk into 10 different hospitals and all will do something different as it is their interpretation, experience, know-how, recommendation etc that tells them what to do. Following IEC 60601 is not wrong, in fact it is very solid however, 62353 provides many benefits over the 60601.

I hope this answered your question in some way. There are already 1000's of biomeds now testing to 62353 (worldwide) and this number is likely to increase because of the benefits it provides (and clarity).

regards,
John

Embrace change, don’t run away from it.

Why on earth would any hospital-based tech want to carry out what are (as everybody knows them to be) "type tests", John? For years techs in the real world have been carrying out routine tests that were deemed to be applicable to the circumstances they work under. They (we) don't need to wait for "guidelines" to come along to tell them (us) what to do.

Everyone who has taken an interest in this issue is aware that 62353 is in fact a kludge that was not fully supported by the Experts from the UK that sat on the drafting committee.

Tell that to IPEM & MHRA who produce sound guidelines. The problem is they (as already pointed out) only cover the UK and parts of Ireland.

I'm not having a go at the UK best practise, just answering questions from other members of the forum that are questioning testing outside the borders of the UK. During my visits around the world, (including meeting Roger in Singapore!) I have come to appreciate that the UK best practise and standards are well ahead of other parts of the world. The IEC / EN / BS 62353 is trying to address this issue in making routine maintenance unambiguous to everyone.

This forum only touches on a small part of questions I'm being asked on routine electrical safety testing which shows that global safety testing is a pertinent issue and since this forum spreads all over the globe (and I consider myself one that promotes this website :[), you have to realise that not all correspondence is "a way of questioning the professionalism of the UK biomed" but merely a means of addressing a wider audience

No one is suggesting that electrical safety testing of medical equipment is not a pertinent issue. And (personally) I'm not particularly concerned about "the professionalism of the UK biomed". Like you, John, I seek a wider audience. But the fact remains that biomeds all over the world don't need to be preached to about IEC (et al) 62353. At the end of the day, electrical safety testing is just part of job, not the "be all and end all"! There's nothing wrong with "pick and mix" (ie, from 60601 or whatever) if that's all a tech has to hand (and that's all his present test kit allows). We are all interested in patient safety ... it's the bedrock that the "profession" (trade discipline) is based upon. Enough already!

But that is the problem! If all are allowed to take a pick & mix approach who is to say what is picked or missed is acceptable? That is the whole point in having a standard such as BS EN 62353. I personally have seen no evidence or technical arguments from "the experts" on the British committee as to why they think 62353 is not good enough. In fact I am appalled they were allowed to insert the wording they did at the front of the BS EN 62353 document.

We all agree that some testing (to whatever standard you like) is better than no testing at all but I don't see why there is not a more positive move to 62353 as and when new test equipment and training allows.

Every comment seems to involve a knocking of the standard without any technical argument. I go back to my original posting over how most people miss the point in 62353 about record keeping and comparisons with pervious test results as this is not common practice currently. I maintain if this comparison is made the 62353 standard will catch far more faults than 60601 ever would.

Be positive and supportive unless there is good technical reasons to complain as this is the best way to move forward and embrace change.

Why do you use words like "if they are allowed", "who is to say", and "I am appalled", Mike? You know, there are still some people about with the competence (and confidence) to draw their own conclusions on technical matters, and act accordingly, without "guidelines" to tell them what to do all day long.

Have you ever carried out electrical safety testing in Africa? Do you imagine that every hospital there has a Rigel 288 to hand?

I doubt that the Experts who documented those comments did so lightly. I am not appalled ... in fact, I applaud them for having what it takes to do that. Are you an Expert as well, then, Mike?

We are not knocking any standard. There is already a trend towards adoption of 62353. It doesn't have to happen over night, does it? And anyway (just like the buses), no doubt there will be another one along soon enough.

But do you have some special agenda here? Are you selling test equipment? If so, why not give us all a break and just spell it out?


Everyone is entitled to their opinions. Who says "this is the best way to move forward"? Move forward to what? Electrical safety testing is already universal. And it has been common practice to carry out such tests as part of PM, and following repairs, for as long as I can remember.

No expert and no agenda!

You applaud the experts for their comments but like them you do not back up your pontifications with any hard technical evidence.

I don't profess to be an expert in the field of electrical safety testing but I was tasked with providing training to our field service engineers. I did my homework and produced the training which has even been shown to those who have performed testing for more than 25 years and even made them think and re-visit the way they perform their tests. I am always willing to learn and be shown the error of my ways even with my 30 years of experience, are you?

Electrical safety testing is not rocket science but some act like it is! The goals of IEC 62353 to provide a simple and cost effective testing method have been met and when implemented correctly are safer than the simple limit mentality of 60601.

Most of my comments are directed at the UK market as what we do today, as best practice, will be followed tomorrow in the developing countries. It is therefore important for us to set a good example.

Geoff, you say everyone is entitled to their opinion but you don't seem to like it when they express it on this forum! I agree everyone is entitled to their opinion but when it is inserted into a technical document such as IEC 62353 I want it backed with facts and figures not feelings!