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DESCRIPTION Applied’s Medical Implant Grade System (HCRP) High Consistency Peroxide Cure Silicone Elastomer System is a one part, silicone elastomer for use in processes where high strength molded, calendared and extruded parts are desired in the Shore A durometer range of 50 and 65. Implant Grade HCRP contains 2,4-dichlorobenzoyl peroxide catalyst which will cure between 110° and 175°C. Postcure is required to remove peroxide residues. Custom formulation of color, radio-opacity, and other requirements is available upon request. |
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BIOCOMPATIBILITY This material was designed to pass ISO 10993 requirements for long term implantation. A sample from each manufactured lot is subjected to an MEM Tissue Culture test. An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available. Additional testing is available on request. |
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APPLICATIONS This product was designed to be used for standard rubber processing techniques such as two roll milling, extrusion, calendaring, compression and transfer molding. Cure is typically achieved in sixty seconds at 125ºC. post cure is necessary to stabilize physical properties and remove peroxide residues. Typical post-cure for a 4 mm thick sample is one hour at 200ºC or two hours at 170ºC. |
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PRECAUTIONS A material safety data sheet is supplied with the shipment. Contact with eyes may cause temporary discomfort. Avoid contact with eyes. Material should be two roll mill freshened before use. Avoid overheating when refreshing because this may cause premature vulcanization. |
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PACKAGING AND STORAGE This product is available in 50 pound kits. This product should be stored under cool dry conditions below 30ºC. Containers should be sealed to avoid contamination. Suggested retest at six months from the date of shipment. |
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LOT TESTING Each production lot has been Cytotoxicity tested and is certified as having passed toxicity and chemical tests assuring uniform chemical and biological properties. Other testing is available upon request. |
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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. Revised APRIL 2006 |
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