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DESCRIPTION Applied Silicone Implant Grade RTV Silicone Adhesives PN 40064 and PN 40076 are high strength one-part products designed for use in fabricating elastic bonds to silicone, polyester and other substrates. The adhesives are room temperature vulcanized (RTV'd) by exposure to ambient moisture in the air to form a tough, elastic bond. While curing, the silicone adhesive gives off acetic acid vapor. Following cure, it is of the same chemical composition as other implant grade silicone elastomers. It contains no solvents or plasticizers. Implant Grade RTV Silicone Adhesive is designed to exhibit high thixotropy in thin sections, but will self level in thick sections. Special features include: • Cures at room temperature
Medical Implant Grade RTV Silicone Adhesive PN 40064 is recommended for silicone- to- silicone bonding applications. PN 40076 is recommended for bonding unlike substrates when 40064 gives inadequate bond strength. |
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BIOCOMPATIBILITY Applied Silicone Medical Implant Grade RTV Silicone Adhesives are designed and tested to meet ISO 10993 requirements for long term implantation. A sample from each manufactured lot is subjected to an MEM Tissue Culture test. FDA Master File references including formulation, manufacturing methods, testing and toxicology are available. Additional testing is available on request. |
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APPLICATIONS Applied's Medical Implant Grade RTV Silicone Adhesives are ready for use. A bond thickness of 0.010" minimum is recommended to achieve optimum strength. Surfaces to be bonded or built-up with RTV Silicone adhesive should be pre-scrubbed thoroughly with a clean, soft sponge or soft-bristled brush in hot water-soap solution to remove possible surface contaminants. Do not use synthetic detergents or oil-based soaps, as these soaps may be absorbed and may subsequently leach out to cause a tissue reaction or reduce bond strength. Rinse copiously in hot water, follow with a thorough rinse in distilled water and dry thoroughly. Apply adhesive then mate surfaces together with light pressure. Partial cure is typically achieved in about twenty minutes. If exposed to ambient moisture, ultimate cure and optimum physical properties will be achieved after 24-120 hours of stabilization. Ultimate rate varies on the amount of material exposed to ambient moisture. Each application must be tested for optimum cure time. Adhesives may be dispersed in a variety of dry aromatic and aliphatic solvents for dipping and coating applications. |
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STERILIZATION Uncured Applied Silicone Medical Grade RTV Silicone Adhesive may be sterilized in the unopened tube by dry heating the sealed tube about two hours at 150º C. After the tube contents are dry heat sterilized, the tube exterior may be sterilized by ethylene oxide or steam autoclave. Gamma sterilization is not suitable for uncured adhesive. Cured adhesive may be sterilized by ETO, steam, dry heat or gamma radiation. It is the responsibility of the user to validate any sterilization method and cycle chosen. |
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PRECAUTIONS A material safety data sheet is supplied with the shipment. The uncured adhesive should not come in contact with eyes, skin, or clothing. Do not breathe the vapor. A small amount of slightly yellowish, watery liquid may accumulate at the tip of the tube. Squeeze out the liquid and proceed to use as normal. During cure the adhesive gives off glacial acetic acid which is a health hazard and tissue irritant. Acetic acid residues should be allowed to dissipate before packaging or using. Use the adhesive with adequate ventilation. The uncured adhesive should not come in contact with eyes, skin, or clothing. Contact with alcohol or other moisture containing solvents should be avoided. Contamination can result in unreliable cure. Low humidity and excessive shelf storage may alter properties. |
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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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PACKAGING AND STORAGE Packaging is available in 90 gram tubes. Custom packaging is available upon request. The adhesive must be stored and transported in accordance with applicable Federal, State, and Local regulations. Store in the original sealed container below 30ºC. 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. Revised 01.28.08 |
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