Medical Grade Silicone
Medical grade silicone is a level of testing done on silicone materials. Some tests performed to classify medical grade silicone are USP class VI biological testing, histopathology, intramuscular implantation, and tissue cell-culture testing. Other testing could include skin sensitization, pyrogenicity, and hemolysis, although not all tests may be conducted to qualify the material as medical grade silicone. Dow Corning uses the term "medical grade" which has become widely accepted industry practice. Other testing of medical grade silicone is performed to determine compatibility with human implantation. (See Dow Corning Website).
Medical grade silicone is often used in injection molding medical components. Medical grade silicone has properties that demonstrate superior compatibility with human and animal tissue and body fluids. It is an inert material and can be used with implantable devices. It also can withstand extreme temperatures, allowing it to be used in sterilization environments. Medical grade silicone is soft and pliable, making it ideal for contact with human skin. Injection molding of medical grade silicone is cost efficient for high volume or single-use applications. Medical grade silicone can be used in gum form and compression molded for low volume requirements.