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

62353:2008 - Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment

This new EU regulation has been brought to my attention but I have been unable to find anything on the internet.
Just wondering if anyone is familiar with the new requirements and if so could they share their findings?
Best regards,
Chris

Here's a good place to start, Chris.

Thanks Geoff,
One of our German competitors (calibration equipment)is claiming haemodialysis machines must be run for a minimum 2 hour period post repair/calibration and all the parameters (conductivity,temperature,ultrafiltration rate,ph etc.) electronically trended for stability before being put back into service,if true the consequences in terms of manpower and spare equipment resources would be enormous.
Does anyone with a copy of the document know if this is the case?
Thanks,
Chris

Well, we all know that our German friends have an enviable reputation for thoroughness!

But see here.

Thanks Geoff,
Just registered hopefully should now be able to see for myself.
Much appreciated.
ATB
Chris

First thing 62353 is not in the UK a manditory standard. This means that in effect you can ignore it if you wish. In effect it is therefore just a best practice "standard".

However when you read it most of what it says is just common sense and the majority of us are doing it any way or some parts of it at least all the time.

It chiefly relates to the question of device electrical safety testing post repair and what or what not to test. Therefore it does not relate in shape or form to the sort of testing etc that we would perform post repair or as part of maintenance in regard to aspects of actual device performance.

In the case of the equipment to which the orginal poster refers what is to be tested is in effect as always down to the individual and the identifed working or service procedures for the device.

To follow the equipment manufacturers instuctions is a matter of an individual risk asscessment for the maintenance organisation supporting the device. Device maintenance should as always be a matter for the maintaining organisation to judge, based on the usual mixture of what is suggested, what is actually possible and organisation historical experiance of the device.

Thanks Paul.
Just in case we have any International members could anyone tell me if it is mandatory anywhere in the EU specifically Benelux which is where my original customer query came from.

By the way top marks to Rigel one of their tech specialists has just rung me to clarify,now that is what I would call efficient,well done Rigel excellent service.
ATB
Chris

Hi Chris
the 62353 is not mandatory in any country. However, that doesnt stop people from using it (or specifying it from a manufacturers point of view). Paul's suggestion to ignore 62353 based on the fact its not mandatory is one I do not share. Ignoring such standards would mean we can ignore just about any standard / guideline document / best practise in the UK (or Europe) as none are mandatory (with the exception of the VDE 0751 in Germany / Austria).

Never the less, in the Benelux, people mostly carry out the IEC 60601 tests based on the capabilities of their testers and what they feel is applicable and leave out potentially destructive tests (their opinion).

Its more than likely that in the near future "European" manufacturers will specify IEC / EN BS 62353 in their service recommendations. Therefore, it would make sense to make yourself familiar with this standard.

Good luck.
john

When this standard was written quite a lot of the UK people involved did not want it as it was thought not really applicable to what we wanted in the UK.

However as it has been passed by the majority of the IEC representative bodies it has therefore been accepted into use almost everywhere except the UK who have as they are required to do published it, BUT have not accepted it into manditory use.

So in answer yes it is.

Thanks Paul, you are right, 62353 is not mandatory (its not mandatory in any of the IEC member states), it was never meant to be mandatory as it is an advisory level standard and not at the level of IEC 60601 / IEC 61010 (which are mandatory). This doesnt however, stop organisations anywhere in the EU to use the 62353 should they wish.