RollingStock
Registered
Hello everyone.
In my company we manufacture intraoral scanners, and I'm unsure of the flammability requirements for our PAINTED outer plastic shell. This shell is not in patient contact, however, it is handled by practitioners. I've read several posts in this forum on flammability of plastic, however, none that specifically address the influence of paints (or generally coatings) on those requirements.
The plastic material is rated for UL94 V-0 @ 1.5mm. So far, I've gathered that EN 60601-1:2006/A2:2021 mandates V-2 or better for TRANSPORTABLE ME EQUIPMENT. I was not able to retrieve any flammability data for our cured paint.
My question is: How are the flammability requirements affected when a known plastic is painted (or in general: coated)? Is it normally considered by auditors? If yes, which tests and data will be required?
Any help is highly appreciated. Cheers
In my company we manufacture intraoral scanners, and I'm unsure of the flammability requirements for our PAINTED outer plastic shell. This shell is not in patient contact, however, it is handled by practitioners. I've read several posts in this forum on flammability of plastic, however, none that specifically address the influence of paints (or generally coatings) on those requirements.
The plastic material is rated for UL94 V-0 @ 1.5mm. So far, I've gathered that EN 60601-1:2006/A2:2021 mandates V-2 or better for TRANSPORTABLE ME EQUIPMENT. I was not able to retrieve any flammability data for our cured paint.
My question is: How are the flammability requirements affected when a known plastic is painted (or in general: coated)? Is it normally considered by auditors? If yes, which tests and data will be required?
Any help is highly appreciated. Cheers