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TECHNICAL BULLETIN

IMPLANT GRADE SILICONE SHEETING
REINFORCED VULCANIZED

Description
MediSil's Medical Grade Sheeting is a flexible, translucent, 50 durometer, silicone elastomer sheeting material designed for limited stress applications. The material can be insert molded or bonded with MediSil unvulcanized sheeting or silicone adhesive. The sheeting is provided in a vulcanized form with a woven or double knit polyester fabric which reinforces the sheeting for dimensional stability and tear resistance.

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. Typical post cure is about 1 hour at 165C. Clean with isopropyl alcohol or other appropriate cleaner. Silicone sheeting may be bonded at room temperature with silicone adhesive or hot press bonded with MediSil vulcanized silicone sheeting.

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.

Post cure is recommended to stabilize properties when necessary.

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

PROPERTY (CURED)
TestResults
Appearance, VisualClear to Translucent
Durometer, shore A units (ASTM D2240)50
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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