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Parylene Coating Applications

Medical Technology and Medical Device Coatings

 

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.


Why Parylene for Medical Coatings?

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.

 

Certifications

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.

Key Coating Properties
  • Biocompatible and bio stable
  • Non-toxic
  • Conforms fully to substrate contours, crevices and edges
  • Thin, transparent film adds minimal weight and volume
  • Withstands repeated sterilization including autoclave
  • Offers dry film lubricity
  • High dielectric properties
  • Super barrier protection
Common Applications of Parylene Medical Device Coatings
  • Probes or Electrodes
  • Needles
  • Mandrels
  • Hearing Aids
  • Prosthetic Devices
  • Guidewires
  • Catheters
  • Cannulas
  • Epidural Probes
  • Electronic Circuitry
  • Molded Products
 
 
Medical Coating Assistance

Contact Curtiss-Wright Parylene Services with questions related to Parylene use in industrial and commercial coating applications, or for assistance with process development and full coating services for your products.


Additional Information

 

Parylene: Coating Solutions for the Medical Industry

Safeguarding Devices for Life

For applications that require a protective conformal coating that’s bio-medically compatible and conforms to USP Class VI and ISO 10993 standards, Parylene provides the answer. This unique coating is transparent and pin-hole free, with a thickness that is both critically controlled and extremely consistent.

It offers a level of protection for critical devices unequaled by other coating alternatives. Parylene is biocompatible, pinhole-free, extremely thin, and protects against the effects of fluids and solvents. The benefits of Parylene are clear:

parylene coated medical devices in operating room

  • Biocompatible, biologically stable and chemically inert
  • Non-toxic
  • Impervious to sterilization by E-beam, gamma ray, EtO, autoclave
  • Conforms precisely to contours • Excellent dry film lubricity
  • Protects against chemicals, moisture and bodily fluids
  • Ultra-thin with deep crevice penetration
  • Excellent dielectric properties
  • Adds minimal weight and volume

 

Parylene Coating for Medical Implants

parylene coated medical implantsParylene provides an ideal coating for coronary stents, pacemakers, defibulators and many other implantable medical devices. It protects the device as well as provides a surface suitable for tissue contact.

 

 

 

Parylene Medical Coating for Elastomers

Catheters, medical seals and similar products utilizing medical grade silicone or rubber require high flexibility, low friction coatings that resist contaminants and discoloration. Parylene, by Curtiss-Wright Surface Technologies answers those challenges.

Parylene Coated Medical Electronics

parylene coated medical electronicsElectronic devices require protection from moisture, body fluids and gases which will cause premature and critical use device failure. Parylene has proven to protect devices from the body and the body from the device.

 

 

 

Medical Wire Parylene Coatings

parylene coated stentsParylene offers significant advantages for coating mandrels and stylets. Its low coefficient of friction enhances the reusability of mandrels. In conjunction with its dry film lubricity and bio-stable / bio-inert characteristics, Parylene provides an ideal coating for stylets, such as extensively applied to vascular therapy devices including:

  • Stents
  • Stent grafts
  • Angioplasty catheters
  • Guiding catheters
  • Guide wires and diagnostic catheters
  • Embolic protection
  • Atherectomy devices
  • Septal defect repair and other occlusion devices

 

 

 

Parylene Coating and Dimer Testing

Study results for ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, USP, EU, ECHA standards.

parylene testing study results for various medical standards

Results of these studies are available on request. Additionally, we maintain device and drug master files with the US FDA. These files include the results of biological studies commissioned by CWST and are available for reference by commercial coating service customers.

HAVE QUESTIONS?

(800) 999-4942 info@parylene.com

We are ready to assist with your Parylene conformal coating needs and answer any questions about your specific product requirements.