Industries
Medical device electronics
Repeated disinfection, sterilisation cycles, body fluids and humidity — against a regulatory expectation that the process is documented as tightly as the product.
What the environment does
The stresses that decide the specification
Cleaning and disinfection chemistry
Alcohols, quaternary ammonium compounds, hypochlorite and hydrogen peroxide are applied to equipment surfaces daily, sometimes hourly. Ingress at a seam puts an aggressive chemical directly onto a board that was specified for humidity, not for solvent attack.
Sterilisation cycles
Autoclave, ethylene oxide and gamma routes each stress a coating differently — steam and pressure, chemical attack, or polymer chain damage. Which route the device sees has to be part of the coating specification, not discovered during validation.
Leakage current and patient isolation
Where an assembly sits inside a patient-connected circuit, the coating contributes to the insulation system. Dielectric performance and coverage at the isolation barrier stop being a reliability question and become a safety one.
Humidity and body fluids
Handheld and bedside equipment meets condensation, spills and aerosols routinely. Coverage at connectors, button apertures and enclosure seams is where the protection is actually won or lost.
Traceability and change control
A coating process feeding a regulated device is part of the device master record. An undocumented change of chemistry or thickness band is a compliance event, not a process improvement.
Coating systems
What is typically specified here
Sector convention is a starting point, not an answer — the environment specification decides. Our engineers will confirm the grade against your actual assembly.
Polyurethane (UR)
Strong resistance to cleaning and disinfection chemistry, plus a robust moisture barrier — the usual choice where surfaces are wiped down constantly.
Silicone (SR)
Where sterilisation heat, thermal cycling or flexibility over a wide range is the governing requirement.
Acrylic (AR)
Non-patient-contact and lower-exposure assemblies where serviceability and rework speed matter more than chemical resistance.
Full comparison: acrylic vs polyurethane vs silicone · Selection method: how to choose a conformal coating
ESD packing
Getting the assembly there intact
- Static shielding bags for assemblies moving between contract manufacturer and device assembly.
- Aluminium MBB with desiccant and humidity indicator for moisture sensitive devices and controlled shelf life.
- ESD thermoformed trays that hold sub-assemblies in fixed orientation through inspection and kitting.
- Clean, particle-controlled handling and clearly labelled lot identification throughout.
Standards
What gets specified
Medical assemblies commonly specify IPC-A-610 Class 3 where the device is life-supporting or life-sustaining, and Class 2 for lower-risk equipment. Material qualification is against IPC-CC-830B. Because the coating process sits inside the device master record, the process sheet, thickness band and inspection method should be fixed and change-controlled rather than left to the supplier’s discretion.
Standards explainerFrequently asked
Medical device electronics questions
Which conformal coating survives medical disinfectants?
Polyurethane is generally the most resistant of the common families to alcohols, quaternary ammonium compounds and hypochlorite-based cleaners, which is why it is the frequent choice for equipment wiped down constantly. The specific disinfectants and their contact frequency should be listed in the specification, because compatibility is a property of the grade rather than of the family as a whole.
Can conformal coating survive autoclaving?
It depends on the chemistry and on how the assembly is protected within the device. Steam autoclaving combines heat, pressure and moisture, and silicone systems generally handle that combination better than acrylic. The sterilisation route — autoclave, ethylene oxide or gamma — must be stated in the coating specification, since each one stresses the polymer differently.
Does the coating affect patient leakage current?
It can, where the coated assembly forms part of a patient-connected circuit. The coating adds dielectric across conductor spacings and contributes to the isolation barrier, so coverage and thickness at that barrier become safety-relevant rather than merely reliability-relevant, and should be verified as part of the isolation design.
Coating for medical device electronics?
Send us the assembly, the environment it has to survive and the standard you are working to. Our engineers come back with a coating system, an application method and a window.