CE-Marking on Class III Medical Device Products: How?

[BGL-Mark]

Dear All,

My first posting because I am desparate and even the accredited test lab gives me fuzzy information...

The problem:
We have several products (a small controller) that are sold with a 9V power adapter included.
So these products were tested as one set (the controller+the adapter in one test) and all passed the LVD-testing. So far so good.

Now we noticed that in different LVD test reports (in one case even from the same accredited test lab) the proposed marking on the products is different:

Marking proposed by lab A:
- The actual controller should be marked with a "class III" label.
- The power adapter should be marked with a "class II" label.
Argumentation: the controller has a low voltage input so it's class III. The power adapter has a 230V input so it's class II.

Marking proposed by lab B:
- The actual controller should be marked with a "class II" label.
- The power adapter should be marked with a "class II" label.
Argumentation: both the controller and its power adapter must be seen as one product so both should be labeled class II.
​

Personally I think that lab A is right but even in one case the same lab make both propositions.
Nowhere I can find exact information on which marking is the right one.
How can help me?
Any websites where I can get this information?

Thanks in advance!
Mark

 

[Ronen E]

Dear All,

My first posting because I am desparate and even the accredited test lab gives me fuzzy information...

The problem:
We have several products (a small controller) that are sold with a 9V power adapter included.
So these products were tested as one set (the controller+the adapter in one test) and all passed the LVD-testing. So far so good.

Now we noticed that in different LVD test reports (in one case even from the same accredited test lab) the proposed marking on the products is different:

Marking proposed by lab A:
- The actual controller should be marked with a "class III" label.
- The power adapter should be marked with a "class II" label.
Argumentation: the controller has a low voltage input so it's class III. The power adapter has a 230V input so it's class II.

Marking proposed by lab B:
- The actual controller should be marked with a "class II" label.
- The power adapter should be marked with a "class II" label.
Argumentation: both the controller and its power adapter must be seen as one product so both should be labeled class II.
​

Personally I think that lab A is right but even in one case the same lab make both propositions.
Nowhere I can find exact information on which marking is the right one.
How can help me?
Any websites where I can get this information?

Thanks in advance!
Mark

Hi,

LVD Article 1:

For the purposes of this Directive, ‘electrical equipment’ means any equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II.

Annex II:

Equipment and Phenomena outside the Scope of this Directive
(...)
Electrical equipment for radiology and medical purposes
(...)

Cheers,
Ronen.

 

[BGL-Mark]

Hi Ronen,

Thanks for your reply.

Attention:
Your thinking is right if the product (in this case "the controller") is sold without the power adapter.
If the products and the power adapter are sold together, things change: in that case both should be tested together because the "set" has 230V mains input.

My problem is how to label the 2 parts of the set?
- Controller (9V input): class II or class III ? (class III seems logical but test labs say it's not)
- power adapter (230V input): class II (seems logical to me)

B Regards,
Mark

 

[Ronen E]

Hi Ronen,

Thanks for your reply.

Attention:
Your thinking is right if the product (in this case "the controller") is sold without the power adapter.
If the products and the power adapter are sold together, things change: in that case both should be tested together because the "set" has 230V mains input.

My problem is how to label the 2 parts of the set?
- Controller (9V input): class II or class III ? (class III seems logical but test labs say it's not)
- power adapter (230V input): class II (seems logical to me)

B Regards,
Mark

Thanks for that.

What is the legal text you are referring to? Annex II exclusion above doesn't seem to be that specific.

If the product is a medical device, I would have referred to the MDD and its rich guidance re. labelling.

Cheers,
Ronen.

 

[BGL-Mark]

Well the I don't have the legal text on hand, otherwise maybe I would also have the answer to my labeling question as well.

However several test labs confirmed my statement independently from each
other.

If somebody could give me confirmation on the labeling as well I would be a very very happy man...

B Regards,
Mark

 

[Ronen E]

Well the I don't have the legal text on hand, otherwise maybe I would also have the answer to my labeling question as well.

However several test labs confirmed my statement independently from each
other.

If somebody could give me confirmation on the labeling as well I would be a very very happy man...

B Regards,
Mark

Well then, I was thinking you were relying on something firm, but I understand that it's not quite so... I'd say that, unless someone would refer us to some other authoritative text, the relevant legal text is the Medical Device Directive (93/42/EEC). In that case you have the text at hand on-line, and most answers are either in it or in the guidance documents also available on-line (MEDDEV's etc.). If you need a hand with the details just give us a shout.

Please note that as respectable as a test house might be, most are not positioned to make a call in such issues (applicability of directives). The proper address would be a Notified Body within the context of medical devices. I assume that the responses you got from the test houses related to the labelling question, had the device/system been subject to the LVD, and that they didn't really look into the directive's applicability to the device. A more appropriate scheme for electrical medical devices / accesories / systems testing would be based on EN 60601-1 (in the broader context of meeting the MDD's essential requirements).

Good luck!
Ronen.