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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. It does not regulate materials other than certain dental materials.
Due to their inert nature, medical-grade Silastic-brand silicone elastomers are important materials in numerous medical and pharmaceutical devices including catheters, pacemaker leads, tubing, wound dressings, silos for abdominal wall defects, [2] and nasolacrimal duct obstruction. [3]
In its uncured state, silicone rubber is a highly adhesive gel or liquid. To convert it to a solid, it must be cured, vulcanized, or catalyzed.This is normally carried out in a two-stage process at the point of manufacture into the desired shape, and then in a prolonged post-cure process.
Tygon Medical Tubing S-54-HL was introduced in 1964 for use in medical applications. This material can be used in catheters , for intravenous or intra-arterial infusion and other surgical uses. Tygon S-54-HL can also be fabricated into cannulae or protective sheath products using thermoforming and flaring techniques.
Dow Corning was formally established in 1943 as a joint venture between the American conglomerates Dow Chemical and Corning Glass to explore the potential of silicone and was a manufacturer of products for use by the U.S. military in World War II. The company began operating its first plant, in Midland, MI, in 1945.
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.
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