Class III Medical Devices

The problem

UV curing in Class III Medical Devices

Class III device manufacturing is where UV curing is held to its strictest standard. The bond is inside a product that goes into a patient, so it is not enough for it to cure — the dose has to be measured, recorded and reproducible across every unit, shift and lamp change.

That is why ETIA sells radiometry alongside every medical installation. Closed-loop lamp systems hold intensity constant over lamp life, traceable radiometers document it, and the resulting numbers are what stand up in an ISO 13485 audit or an IQ/OQ/PQ package.