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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.
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. It can also be injection molded or 3D printed.
Silicone gel is made of medical-grade silicone polymers. [4] Silicone gel sheet consists of a soft, semi-occlusive sheet and a membrane that increases the durability of the sheet. [3] The sheet has a solid rubber-like appearance. Although the mechanism of action of silicone gel sheeting remains partially unknown, its efficacy is confirmed by ...
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.
They can vary in consistency from liquid to gel to rubber to hard plastic. The most common siloxane is linear polydimethylsiloxane (PDMS), a silicone oil. [citation needed] The second-largest group of silicone materials is based on silicone resins, which are formed by branched and cage-like oligosiloxanes. [citation needed]
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]
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