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DESCRIPTION Applied Silicone Implant Grade Liquid Silicone Rubber (LSR) Systems are two part, 100% solids, pure dimethyl silicone elastomers, engineered for use in liquid injection molding (LIM) processes where high strength molded parts are desired for medical devices. Liquid Silicone Rubber (LSR) is a pumpable, colorless, translucent paste. When A and B components are mixed together in equal portions, the liquid will cure to a tough, rubbery elastomer via addition-cure chemistry. Custom formulation of radiopaque or color masterbatch is available upon request. This product is available in durometers of 10 to 50 Shore A. The LSR System is supplied in two component kits consisting of equal amounts of Part A and Part B. Advantages over peroxide catalyzed systems include: • Improved clarity
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BIOCOMPATIBILITY Applied Liquid Silicone Rubber (LSR) Systems are designed and tested to meet ISO 10993 requirements for long term implantation. A sample from each manufactured lot is subjected to MEM Tissue Culture testing. FDA Master File references, including formulation, manufacturing methods, testing and toxicology are available. Additional testing is available upon request. |
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APPLICATIONS Applied Implant Grade Liquid Silicone Rubber (LSR) Systems are designed to be mixed in equal parts using standard LIM processing equipment and techniques. Cure is typically achieved in twenty seconds at 160º C. Cure rate can be increased by increasing temperature. Postcure is suggested to stabilize physical properties for implant applications. LSR is especially designed for manufacturing health care devices by either liquid injection molding or liquid extrusion. Some specific applications include: • Precision molded
parts
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BLENDING Applied Liquid Silicone Rubber (LSR) Systems are supplied as A and B components which must be combined in equal portions prior to use. Airless mixing, metering, and dispensing equipment is recommended for production operations. Information is available from Applied Silicone Corporation on such systems. |
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PRECAUTIONS Accurate measuring and complete mixing are important factors in obtaining consistent results. Special care must be taken to assure clean molds and a clean work area no organic rubbers should be used on the same processing equipment because traces of foreign materials can poison the catalyst and inhibit the cure. All metering and mixing equipment should be thoroughly clean. Polymer systems which contain traces of amines, sulfur, nitrogen oxide, organotin compounds and carbon monoxide can interfere with the cure of this material and should be avoided. A Material Safety Data Sheet (MSDS) is supplied with shipment. Contact with the eyes may cause temporary eye discomfort. Avoid any contact with the eyes. |
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LOT TESTING Each production lot is certified as having passed Cytotoxicity and physical properties. Other testing is available upon request. |
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PACKAGING AND STORAGE Liquid Silicone Rubber is available in kits of 80 and 800 pounds. Suggested retest date is six months from date of shipment. |
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DISCLAIMER Applied Silicone Corporation
warrants that this product meets applicable
descriptions and specifications for a period of six months from shipment.
No other warranties, expressed or implied,
are intended. This product was designed for sophisticated users. The user must carefully
review literature for uses where adverse
effects are reported for certain applications of silicone in medical devices. The user
of this material must independently determine
that any product incorporating this material is safe and effective. The user of
this material must thoroughly test any application
consistent with industry requirements and/or standards. Applied Silicone Corporation
disclaims any expressed or implied warranty
against the infringement of any patent. Any suggestion of use by Applied Silicone should
not be taken as inducement to infringe
on any particular patent.
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