Applied’s Implant Grade High Strength RTV Silicone Elastomer Dispersion PN 40021 is designed for use in fabricating high strength, elastic silicone membranes of virtually any shape and thickness. A membrane is generally formed by coating processes such as dipping, casting, spraying, knife coating, or brushing. After evaporating the solvent, the silicone is room temperature vulcanized (RTV'd) by exposure to ambient moisture in the air, and a tough elastic membrane is formed.

The product is supplied as a one part dispersion in xylene, an aromatic solvent. It can be diluted with an aliphatic or aromatic solvent. The dispersion is designed to exhibit high thixotropy providing exceptional build at low processing viscosities. Important characteristics include:

•  Ready to use and easily applied or shaped
•  Cures at room temperature
•  Resistant to cure inhibition
•  High elongation

This material was 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. 

An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available. Additional testing is available upon request.

This product is ready for use.  When multiple coats are applied, most of the solvent should be evaporated before a subsequent coat is applied. Typically during the coating process, mild heat (up to 35º C) and air circulation are used to remove solvent vapors. 

Under conditions of rapid devolatilization of the thin sections, 90% cure could be achieved in about two hours at 90º F and fifty percent relative humidity.  Ultimate cure physical properties will be achieved after twenty-four hours of stabilization.

A material safety data sheet is supplied with the shipment.  The dispersion contains the solvent xylene which is a flammable liquid and a health hazard. During cure, the material liberates  acetic acid.  The dispersion should not come in contact with eyes, skin, or clothing.  Do not breathe the vapor.  Keep away from open flame, sources of sparks, and heat. When transferring the dispersion, ground all vessels to prevent sparks.  The user is urged to be familiar with the properties of acetic acid and xylene. 

Contact with alcohol or other moisture containing solvents should be avoided. Contamination can result in an unreliable cure. Failure to achieve rapid devolatilization during cure may alter ultimate cure properties.

Multiple dip processes should be performed at short (approximately  minute) intervals to avoid "mudcracking."

This product is available in 1 gallon cans, 5 gallon pails, and 55 gallon drums. 

The dispersion is a  flammable liquid and must be stored and transported in accordance with applicable Federal, State, and Local regulations. 

Store in the original sealed container below 30ºC. Keep container tightly closed when not in use. 

Each production lot is certified as having passed Cytotoxicity and physical testing. Additional testing is available upon request.

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 10.07.03