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Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. [1] In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body.
Silicone rubber is an elastomer (rubber-like material) composed of silicone—itself a polymer—containing silicon together with carbon, hydrogen, and oxygen. Silicone rubbers are widely used in industry, and there are multiple formulations.
The Food and Drug Administration (FDA) approved an artificial ligament made of Gore-Tex for use in ACL reconstruction in 1986. [6] The design of artificial ligaments in the 1980s consisted of two major parts: a relatively stiff cable or tape, and silicone rubber cylinders on one or both ends. [2]
The rubbery, vinegary-smelling silicone caulks, adhesives, and aquarium sealants are also well-known. PDMS is also used as a component in silicone grease and other silicone based lubricants, as well as in defoaming agents, mold release agents, damping fluids, heat transfer fluids, polishes, cosmetics, hair conditioners and other applications.
Injection molding of liquid silicone rubber (LSR) is a process to produce pliable, durable parts in high volume.. Liquid silicone rubber is a high purity platinum cured silicone with low compression set, good stability and ability to resist extreme temperatures of heat and cold ideally suitable for production of parts, where high quality is required.
The ORIGAMI Female Condom (OFC) is fabricated in molded silicone for anatomical conformity. It was validated as 100% biocompatible and non-allergenic in independent pre-clinical lab testing. The condom is not yet approved for sale and must be reviewed by the WHO, the C-Mark (EU), and the FDA to meet regulatory safety requirements.
A wide variety of non-biodegradable polymers have been used for orthopedic applications including silicone rubber, polyethylene, acrylic resins, polyurethane, polypropylene, and polymethylmethacrylate. The primary role of many of these polymers was to act as a biocompatible cement in the fixation of prostheses and in the replacement of joints.
RTV silicone rubber can be used to cast materials including wax, gypsum, low-melt alloys/metals, and urethane, epoxy, or polyester resins (without using a release agent). A more recent innovation is the ability to 3D print RTV silicones.
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3785 Park Mill Run Dr, Hilliard, OH · Directions · (614) 777-6170