Applied Silicone Implant Grade Liquid Silicone Rubber (LSR) 10:1 Systems are available in 25 and 30 durometer hardness.  They are a two part, pourable, 100% solids, liquid, dimethy silicone elastomer, designed to be mixed at 10 parts base (Part A) to 1 part crosslinker (Part B).  The mixture will cure to a high strength, clear flexible elastomer.  The crosslinker ration can be adjusted to yield a softer elastomer.  These materials are engineered to cure at room temperature, to meet the highest standards of purity and quality, for applications in implantable medical devices.

LSR 10:1 Systems cure unlimited thick section with no cure by-product.  Cure can be accelerated to seconds with proper mold design and temperature.  The resulting elastomer is very stable and can be sterilized with steam, gamma radiation or ethylene oxide.  Custom formulation of radiopaque or colored masterbatches is available upon request.

Important characteristics include:

•  Pourable consistency
•  Physical and electrical stability
•  Low shrinkage when cured at room temperature
•  Unlimited thick section cure
•  Heat accelerable cure

•  Requires no special molding equipment

This material is intended for long term implant applications and was designed and tested to meet many of the ISO 10993 requirements.  A sample from each manufactured lot is subjected to an MEM Tissue Culture test.  Additional testing is available upon request.

Manufacturing of this product is performed under stringent quality control and is fully traceable per ISO 9001:2000 procedures.  An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available.

Users 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.

Applied Implant Grade Liquid Silicone Rubber (LSR) 10:1 Systems are designed to be mixed in the ratio of 10-part by weight Part A to 1-part by weight Part B.  The firmness can be adjusted by reducing the proportions of the Part B component.  The cure may be accelerated by heating. 

Weigh out the desired quantities of Part A and Part B.  Combine and mix thoroughly.  Degassing under vacuum at 28" to 30" Hg for about thirty minutes is often necessary to cast void free parts.  Applied Silicone offers specially designed vacuum chambers for easy air free quick mixing.  Pour or inject mixed material into mold and cure.  When high pressure molding processes are used, vacuuming is not necessary.  Post cure is recommended to stabilize properties.

Airless mixing, metering and dispensing equipment is recommended for production operations.  Special care must be taken to assure clean molds and a clean work area.  

A Material Safety Data Sheet is supplied with shipment.  Avoid contact with the eyes; contact may cause temporary eye discomfort.

Liquid Silicone Rubber (LSR) 10:1 Systems are available in kits of 8.8 pounds, 44 pounds and 440 pounds.  This material should be stored under cool and dry conditions below 30°C.

Suggested retest date is six months from the date of shipment.

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

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 08.21.07