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TECHNICAL BULLETIN

IMPLANT GRADE SILICONE SHEETING
NON-REINFORCED VULCANIZED

Description
MediSil's Medical Grade Sheeting is a flexible, translucent, 50 durometer, silicone elastomer sheeting material designed for custom forming and bonding applications. This Non-Reinforced Vulcanized Sheeting is provided in a vulcanized form with excellent physical properties.

Biocompatibility
This material was designed to meet ISO 10993 requirements for long term implantation and testing is based on the May 1993 FDA Guidelines Supplement to the CFR 90300204 for Dow Corning Medical Grade replacements. A sample from each manufactured lot is subjected to an MEM Tissue Culture test. Additional testing is available on request.

This product is manufactured to conform to GMP guidelines defined in CFR 21, Part 820. Compendiums, supported by FDA Master Files, are available.

Applications
Remove polyethylene protective sheets. Post cure to stabilize properties as required. Typical post cure is about 1 hour at 165C. Rinse with isopropyl alcohol to clean.

Precautions
A material safety data sheet is supplied with the shipment. No special precautions are necessary.

Silicone absorbs contaminants from the environment. Keep packages closed. Avoid moisture when bonding to sheeting.

Packaging and Storage
This sheeting is supplied in 9" x 12" and 8" x 6" sheets. Custom sizes and thickness is also available. For pricing and availability information and to place an order, please contact us at: 805-525-5657 or by email at siliconesales@MediSil.com.

This product should be stored under cool, dry conditions. Containers should be sealed to prevent absorption of airborne contaminants.

Suggested retest date is six months from the date of shipment

Lot Testing
Each production lot has been Cytotoxicity tested and is certified as having passed toxicity and chemical tests to assure uniform chemical and biological properties. Other testing is available upon request.

Typical Properties
*Please note that these values are not intended for use in preparing specifications

THICKNESS 10 mil 20 mil 30 mil 40 mil 50 mil 60 mil
PROPERTY (CURED)
TestResults
Appearance, VisualClear to Translucent
Durometer, shore A units (ASTM D2240)50
Tensile Strength, psi (ASTM D412)1600
Elongation, % (ASTM D412)850
Tear Strength (ASTM D624)250
Cytotoxicity, MEM Tissue CultureNon-Toxic

Disclaimer
MediSil 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. 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. MediSil Corporation disclaims any expressed or implied warranty against the infringement of any patent. Any suggestion of use by MediSil should not be taken as inducement to infringe on any particular patent.

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