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Has BS EN 60101-1 changed that significantly with regard to labelling?
We have had a new endoscopy stacking system delivered with no electrical safety markings on the any of the equipment, but the Class and Type are in the manuals.
Another item, an electrically powered dental sedation unit doesn't even have anything in the user manual.
The 2006 version of the standard states that labels ahall be in the manual and on the equipment (not round the back as the labels used to be, but in a position where the intended operator can see them. Am I getting old and missing something here? Grateful for any advice.
Graham

Is the equipment American? Over the years i've noticed that much of the equipment made in the states supposedly complies with 60101-1 but falls short on labelling.

Lee

The new version of the standard has more requirements for labelling than the previous one. In fact, due to the requirement to apply a risk management preocces in accordance with ISO 14971, it can be expected that labels in general willget a pump, as the manufacturer would be obliged to describe, by the risk management process, all residual risks that could not be controled by design into the equipment (and thus would require markings or info in the docs to keep the risk acceptable).

But, as Lee said, this would be true if the equipment is totally in conformance with the standard. As conformance is voluntary - the manufacturer can always adopt other solutions to keep risks acceptable - there could be cases in which there are less labelling (weird, i know)

The sedation unit is American, but with the changes to a more obvious labelling (instead of grovelling around the back of the equipment), I would have expected the basic B, BF etc symbols on all the equipment, clearly visible from the operators position. None of this equipment has any such labels with the exception of the mains supply etc at the rear of the kit.

Hello Graham,

What does the supplier say? Generally, if it hasn't been labelled correctly I would reject it.

In this situation i would also reccommend you ask them whether it conforms to MDD93/42 (Medical devices directive for Europe) What classification is it? 1, 2a or 2b? Which testing house they used, and a copy of the testing house certificate that states it is CE marked to the right directive. I have had equipment come in from companies based outside the EU that did not test their kit to the right standard but did have a CE mark (usually to some industrial standard).

The PPQ forms for the endoscopy equipment all have the MDD93/94 boxes ticked and all are class 1, with the exception of the light source which is class 2a.
I have spoken to the supplier who has stated that they have 2 years to comply with the 3rd edition of BS EN 60101-1 which was published in 2006, so I took the 1990 version home and there in clauses 5 and 6 is the "shall" term in relation to markings.
This system was made outside the EU but is a major international player in the endoscopy field.
I will be back onto them today and quote the previous edition to them.
Problems like this are where the EBME website excels and I am obviously grateful for all the advice and comments.
Graham
Thanks for all your help and advice
Graham

Hello Grahan

Standards are voluntary in the MDD (and also in EUA, Canada, etc...it seems to me that they are obligatory just on Brazil, this being a shame :-() So, the fact the standard says "shall" does not mean very much. Even when the new edition of IEC 60601 enters the list of harmonized standards (and your supplier information is in fact wrong - the transition period for equipment which has particilar standards is not yet defined due to the alignment of particular standard with the third edition of the general one), they do not have to follow requirements from the standards. They have to demonstrate that all risks related to the equipment are acceptable.

This is a real problem because this is general is on the risk management file, which manufacturer generally do make make public.

Hello Mantunes,

Under the Medical devices directives (MDD93/42), only class 1 can be self certified. All class 2a, 2b, and class 3 devices must me tested in accordance with the EU MDD by a registered testing house such as BSI, TUV, etc.

If manufacturers do not meet the standards, they are not allowed to sell their products in Europe.

Hello John

I was not talking about self-certifiction.

I will reproduce here my post from Elsmar Cove:

An important point is that the more general harmonised standards are particularly powerful in enabling manufacturers to demonstrate compliance with the essential requirements of the MDD (93/42/EEC) and globally, potentially, without having to "reinvent the wheel", so to speak. Being general they apply to all medical devices so they are important reference documents RE: safety aspects.

The standards provide enough technical detail to allow manufacturers to minimise the risks associated with design and manufacture of medical devices. The rationales in later standards actually provide information for the manufacturer to establish whether to apply a more risk-based approach or to adopt the approach outlined in the standards.

Examples such as markings are not a good example to use when discussing a "flexible" approach to applying standards since the symbols and requirements are actually quite prescriptive, i.e. fuse values, input power consumption, input tolerances, ratings, etc, must be labelled with the industry-standard symbols and markings.

As for applied parts it's absolutely necessary to declare what they are, what they consist of and to label the device appropriately - with the standard symbols or warnings we all recognise - even the 3rd edition standard specifies markings and how they're to be applied.

In other more technical aspects there is more flexibility, in my opinion, but rather less with labelling, marking and documentation, in practice. Requirements are laid down quite explicitly in all editions of the general standards and even more so in particular standards where essential performance is also discussed.

Requirements for essential performance and safety can be quite prescriptive in particular standards. I guess to meet equivalent levels of performance and safety using different, possibly risk-based, approaches to the problem gets more difficult as more specialised devices are considered.