PRODUCT INFORMATION SHEET

APPLIED SILICONE CORPORATION

IMPLANT GRADE DIMETHYL SILICONE DISPERSION IN XYLENE

•  Fully formulated system
•  Available in one or two component systems
•  Excellent physical properties

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.  Additional testing is available upon request.

FDA Master File references including formulation, manufacturing methods, testing and toxicology are available.
 

When supplied as a two part system, this product was designed to be combined in the ratio of  0.7 parts by weight crosslinker to 100 parts by weight of silicone solids (not dispersion).  Weigh out the desired amount of dispersion and determine the weight of silicone solids present.  The composition of the dispersion is expressed in terms of percent solids by weight.  This value is supplied with the shipment.  Add the appropriate quantity of crosslinker and mix thoroughly.

The fully formulated dispersion can be applied to a mold or substrate.  When multiple coats are applied, most  of  the solvent should be evaporated before a subsequent coat is added.  Typically during the coating process, mild heat (up to 50ºC) is applied and air circulation is used to remove solvent vapors.

After the last coat is applied, and when most of the solvent has evaporated, the material can be cured with the application of heat.  Time and temperature requirements will be dependent on the particular application, and should be determined by the user.  As a guideline, thirty minutes at 150ºC is generally sufficient.

A Material Safety Data Sheet (MSDS) is supplied with the shipment. The dispersion contains the solvent xylene which is a flammable liquid and a health hazard. The dispersion should not come into contact with eyes, skin, or clothing.  Do not breathe the vapor.  Use the dispersion with adequate ventilation. Keep away from open flame, sources of sparks, and heat. When transferring dispersion, electrically ground all vessels. The user is urged to be familiar with the properties of xylene.

Accurate measuring and complete mixing are important factors in obtaining consistent results. Contamination can result in an unreliable cure. Avoid sulfur or amine containing gloves which can poison the platinum catalyst.

The crosslinker is a polysiloxane and may cause temporary eye discomfort.  Avoid contact with eyes.

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

The dispersion is available in 1 gallon cans, 5 gallon cans, and 55 gallon drums. The crosslinker is added at the factory. The suggested retest date is ninety days from the date of shipment. The crosslinker may be supplied separately as a two part system, and retested  six months from the date of shipment.

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

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