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I was just after some help i have today come to accept a medical device on our acceptance form it requires the device to have a label showing classification. Is this a requirement o the medical device directory, or DB9801 or IEC 60601-1??

Please Help

It's a standard requirement. Although not a big deal (in my opinion).

Which standards document are the people there expecting you to follow?

More important than the labeling is the correct notification on the acceptance form (computer database etc.) of the item's electrical class and type, as this will determine which electrical safety tests will be carried out in future (eg, during PM).

Sometimes the electrical classification of the equipment is obvious. What sort of kit are we talking about here, Nozza, something special?

Maybe this is useful!

Medical Device Classification according to its risks ...... Class I, IIa, IIb and III.

Medical Device Classification according to its electrical safety type and protection, Class 1 and 2; Type B, BF, CF.

Sorry Roger, but we don't like "Class" being used for both risk (perceived risk to the patient?) and electrical classification. People get confused enough as it is!

ESC:- Class and Type (according to the well known IEC rationale).

Risk:- some sort of scoring regime (ie, a number), or High, Medium, Low or what have you.

I believe that Nozza was (is) just trying to tick the boxes on his acceptance form.

Its not a special piece of equipment its class 1 B as found in the manual, my gripe is that my acceptance form as to db9801 says it should have a label on the equipment, but it doesn't i also notice that the CE marking does not have the 4 digits folowing it.

The company says it doesnt need to be on the equipment as long as its in supporting documentation.

I have looked on the internet and found that as to MDD93/42 the CE mark should be followed by 4 digits Medical Device Directorate for Europe.

What shall i do my boss says i shouldn't accept it but i want to be clear on what is right

As I said before:- which document are you following? What is MDD93/42 ... there have been many such documents that simply add to the overall confusion. Is it still valid?

Regarding the CE mark, there has been much discussion about this useless appendage on this forum. To my mind, it has nothing to do with raising standards, but in fact has the opposite effect (through allowing sub-standard junk to be sold in the UK market).

If your boss doesn't want to accept the item, then I guess that's up to him. But, is it a bit of kit that everyone else in the Kingdom is already happy with, I wonder?

PS: see this link.

Yes, probably so.

thats very helpful Geoff

But in respect to the basic question, is there anything that stipulate this device should have a label on it somewhere saying it is a class 1 B?

Again, you have to decide which standards document you are meant to be following! I don't consider myself to be really up to date on all this stuff (life's too short) ... but I believe that a manufacturer can "self-certify" (that is, make a declaration) in cases of Class 1 equipment.

After all, you can prove it's Class 1 by a simple test with your Electrical Safety Tester (or, come to that, your multimeter), can you not?

And what's the symbol for Type B?

Meanwhile (and just to muddy the waters a little further), what does the PPQ have to say, I wonder?

CE mark is a mark of conformity in the European Economic Area.

The identification number on the CE mark relates to the notified body and this number signifies the involvement during the design and production phases.

Generally, there should be a "Type" symbol affixed to the machine or else ask your vendor for the safety certification doc where it indicates the Class and Type identification.