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Medical devices and instruments often require FDA compliant coating protection that is fully conformable, biocompatible and bio stable. Inert, vacuum deposited Parylene film meets rigorous medical coating requirements more effectively than any other conformal coating, making it the long-standing material of choice for items ranging from needles and catheters to epidural probes, medical device circuits, and mandrels.
This thin, transparent film resists the effects of moisture, organic and inorganic chemicals, organic solvents, acids, reagents, bio-fluids and oils. It forms a barrier to moisture and gases that is substantially more effective than alternate coatings. The film has a low coefficient of friction (similar to Teflon™), providing useful lubricity in medical device coating applications. All of these properties are achieved with very thin, low-mass coverage that does not interfere with device or component performance.
Various medical surfaces coated with Parylene including glass, metal, ceramic and plastics, can be repeatedly sterilized without degrading the coating.
Parylene is an FDA-approved, USP Class VI polymer. Para Tech obtained FDA drug and device master files in September 2011, and this FDA record allows customers to use our process information on premarket approval applications (PMAs), investigational device exemptions (IDEs), premarket notification submissions (510(k)s), reclassification petitions, color additive petitions or other FDA submissions pertinent to Parylene coating. Parylenes N and C supplied by Para Tech comply with USP biological testing requirements for Class VI plastics.
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