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TECHNICAL BULLETIN

IMPLANT GRADE SILICONE SHEETING
NON-REINFORCED UNVULCANIZED

Description
MediSil's Medical Grade Reinforced Unvulcanized Silicone Sheeting is a flexible, translucent, 50 durometer, uncured silicone elastomer sheeting material designed for limited stress, custom forming and bonding applications. Once vulcanized, the material can be cut and bonded with silicone adhesives. This reinforced Non-Reinforced Unvulcanized Sheeting is provided in a pre-catalyzed with a dichlorobenzoyl peroxide catalyst.

Biocompatibility
This material was designed to meet ISO 10993 requirements for long term implantation. A sample from each manufactured lot is subjected to an MEM Tissue Culture test.

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

Applications
Remove polyethylene protective sheets. Post cure to stabilize properties if required. Press or hot air cure between 110C and 200C. Post cure to stabilize properties and remove peroxide residues. Typical post cure is 2 hours at 165C to 1 hour at 200C. Clean with isopropyl alcohol or other appropriate cleaner.

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

Post cure residue (2,4 dichlorobenzoic acid) must be properly handled in accordance with local, state and federal regulations.

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 below 30C. 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
PRESS CURED, 5 MINUTES AT 120C
POST CURED, 1 HOUR AT 175C
TestResults
Appearance, VisualClear to Translucent, Colorless
Durometer, shore A units (ASTM D2240)50
Tensile Strength, psi1600
Elongation, %700
Tear Strength, ppi190
Specific Gravity (ASTM D792)1.16
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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