IMPLANT GRADE SILICONE SHEETING
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.
- MediSil provides 9" x 12" and 8" x 6" sheets in the following thickness standards: 0.010", 0.020", 0.030", 0.040", 0.050" and 0.060"
- This sheeting is protected on both sides by polyethylene and available in 10 sheets per pack.
- Custom sizes, thickness and pigmentation are available upon request.
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
Remove polyethylene protective sheets. Post cure to stabilize properties if required. Press or hot air cure between 110°C and 200°C. Post cure to stabilize properties and remove peroxide residues. Typical post cure is 2 hours at 165°C to 1 hour at 200°C. Clean with isopropyl alcohol or other appropriate cleaner.
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 30°C. Containers should be sealed to prevent absorption of airborne contaminants.
Suggested retest date is six months from the date of shipment
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.
*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 120°C|
POST CURED, 1 HOUR AT 175°C
|Appearance, Visual||Clear to Translucent, Colorless|
|Durometer, shore A units (ASTM D2240)||50|
|Tensile Strength, psi||1600|
|Tear Strength, ppi||190|
|Specific Gravity (ASTM D792)||1.16|
|Cytotoxicity, MEM Tissue Culture||Non-Toxic|
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.