Medical Devices

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For medical applications that require a protective conformal coating, biomedical compatibility, meeting FDA Class VI requirements, and deposition to a thickness that is both critical and extremely consistent, parylene is the answer.

Parylene is a pin- hole free protective barrier against biofluids, moisture and chemicals. All coatings have small, but measurable, permeabilities such as water and common gases, however, parylene’s water vapor transmission is significantly lower than most conventional coatings.

Along with great barrier protection for medical devices, parylene also acts as a dry film lubricant. Parylene has a coefficient of friction measurement that approaches that of TEFLON®. Parylene type “N” is used typically in applications requiring this type of releasability or dry film lubricant.

Parylene Coating Services maintains an FDA device and drive master file that can be referred to in your IDE, PMA or 510(K) submissions.

Some typical medical applications for parylene

CATHETERS, MANDRELS- Catheters, being molded parts, can be parylene coated to improve lubricity. This will help in reducing the chatter of insertion or removal that is experienced when using a non-coated catheter. Parylene also affords barrier protection against biofluids. Mandrels, being precise wire forms used in the production of catheters, are coated with parylene for the ease of releasability of the newly formed catheter from the forming mandrel.

CARDIAC ASSISTED IMPLANTABLE DEVICES- Because of parylene’s excellent dielectric properties, not only are pace makers and implantable defibrillators protected against corrosive effects of biofluids, but the metal cases of these devices are also isolated electrically

Other applications include pressure sensors, medical instrumentation printed circuit boards, ultrasound transducers, guide wires, needles, epidural probes and elastomer products (silicone, latex gasket and seals), wherever lubricity and barrier protection is required.

See Technical Information for details.

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