Parylene film sterilization methods reviewed.

Specialty Coating Systems (SCS, Indianapolis; 800/356-8260) has conducted a series of tests to determine the effects of common sterilization methods on parylene coatings. Laboratory-assisted test procedures included steam autoclave, gamma and E-beam radiation, H₂0₂ plasma, and EtO methods. Several parylene N and C samples were analyzed for changes in dielectric strength, water-vapor transmission, coefficient of friction, and tensile properties. Parylene, a pinhole-free protective film, is used in a wide range of medical applications, including electronic pressure sensors, cardiac assist devices, prosthetic components, catheters, and needles and cannulae. Poststerilization test results are available for reference by SCS customers through the company's FDA device and drug master files.