Are Coating, Painting and Labels part of the Enclosure of ME Equipment

T

temujin

#1
Hi,

I am currently gathering data (material, flame rates)on the enclosure of our medical equipment, which consist of metal/plastic parts which are coated (powder coated or wet painted).

Should the paint material be counted as Enclosure? What kind of certificates would it be necessary to have on the coating material?

edit: What I really need to know is: Is there any requirements related to the paint/coat material (flamability etc ) for medical devices or parts of medical devices that are painted with either powder coating of wet paint...

regards
t.
 
Last edited by a moderator:
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Al Rosen

Staff member
Super Moderator
#3
Hi,

I am currently gathering data (material, flame rates)on the enclosure of our medical equipment, which consist of metal/plastic parts which are coated (powder coated or wet painted).

Should the paint material be counted as Enclosure? What kind of certificates would it be necessary to have on the coating material?

edit: What I really need to know is: Is there any requirements related to the paint/coat material (flamability etc ) for medical devices or parts of medical devices that are painted with either powder coating of wet paint...

regards
t.
You can find the answer to your question in the iec 60601 standards. I believe that the enclosure is tested with the paint. The extent of the testing is determined by the size of the enclosure.
 
J

joshua_sx1

#4
Should the paint material be counted as Enclosure? Depends on your product specifications… you can go back to your design & development planning and see how your Design & Development Department categorized & defined your enclosure…

What kind of certificates would it be necessary to have on the coating material? Certificate of Compliance is usually being issued for this purpose… specifying the standard you use to test, verify & validate the coating material you used… but there are other certificates for this purpose e.g. a certificate from third party testing laboratory…

Is there any requirements related to the paint/coat material (flamability etc ) for medical devices or parts of medical devices that are painted with either powder coating of wet paint...

…there are… I have a friend who is working in painting company and dealing with the same scenario as yours… I’m not sure if he is still working there but I’ll try to send him an email after posting this reply… and I will update you if I receive one… but anyway, as far as I remember, their requirements are always based on their customer requirements such as the standards they have to comply with, or in other cases, as specify by the customer itself… and these are part of their contract review & planning of product realization...
 
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