There are now more than a dozen plastic materials approved by the FDA for medical use. Most medical uses do not include body implantation but do include medical devices, treatment products, diagnostic instrumentation and patient care appliances and fixtures.
These FDA compliant plastics have all the manufacturing advantages of plastic, but also contain properties that make them compatible for medical uses.
The list of FDA approved plastics includes at least some grades of:
- Acetal Copolymer
- Delrin aka (also known as) acetal homopolymer
- PET-P = polyethylene terphthalate polyester
- Fluorosint = mica-filled PTFE = polytetrafluoroethylene
- Halar = ECTFE = ethylene-chlorotrifluoro-ethylene
- Hydex = PBT-P = polybutylene terephthalate-polyester
- Kynar aka PVDF = polyvinylidene fluoride
- Noryl aka PPO = polyphenylene oxide
- PEEK = polyetheretherketone
- Polyethylenes including LDPE, HDPE and UHMW
- Polypropylene homopolymer
- PPSU = Polyphenylsulfone
- PSU = Polysulfone
- Radel A = polyethersulfone
- Radel R = polyarylethersulfone
- Rulon 641
Medical plastics can be sterilized with high energy radiation including gamma rays or electron beams, or sterilized chemically with ethylene oxide which will not cause permanent discoloration. They offer a level of chemical resistance that makes them usable in cytotoxic and nuclear medicine. They have the chemical stability that makes them suitable for long-term contact with human tissue. Medical grade plastic films are skin friendly. The plastic film can be semi-permeable which means that they can be water repellent on the outside but allow water vapor to escape. Antibacterial plastics cut down on infection.
Plastics have the advantages of low manufacturing costs, low friction and wear in moving parts, low mass and weight. Plastics enable the manufacture of flexible ergonomic designs, not possible with more rigid, less malleable materials. They can be designed to maintain their physical properties under high levels of physical, thermal, chemical and electrical stresses. They can be abrasion resistant, shatter resistant, they can be engineered to have various electrical properties, and these medical grade plastics comply with set medical regulations. They also have the benefit of being manufactured to very precise tolerances.
Colorado Plastic Products is a full-service distributor of a complete range of plastic sheets, rods and tubing. We also offer custom fabrication with a wide range of aplications. Please contact us to learn more about our services and how we can help you achieve your plastic needs.