Medical Devices Manufacturing - 1 - Bluestar Silicones
Medical Devices Manufacturing - 1 - Bluestar Silicones
Medical Devices Manufacturing - 1 - Bluestar Silicones
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SILBIONE ® DISPERSIONS<br />
Silbione ® Product Typical Applications Typical Properties<br />
Silbione ® Dimethyl<br />
Elastomer Dispersion<br />
Silbione ® HS Elastomer<br />
Dispersion, RTV in Xylene<br />
Silbione ® Product Regulatory Biocompatibility<br />
Silbione ® Dimethyl<br />
Elastomer Dispersion<br />
Silbione ® HS Elastomer<br />
Dispersion, RTV in Xylene<br />
Specialty Fluids,<br />
Dispersions<br />
and Defoamer<br />
FDA Master File (MAF)<br />
FDA 21CFR 347.10<br />
Indicates test performed on the material; successfully passed.<br />
Indicates test not performed on the material; however, it is substantially<br />
equivalent to another tested Silbione ® product.<br />
Fabricating high strength, elastic<br />
silicone membranes and balloons<br />
of any shape/thickness.<br />
Dipping<br />
Coating<br />
Cytotoxicity<br />
For detailed commercial contacts please visit our website:<br />
www.bluestarsilicones.com<br />
healthcare@bluestarsilicones.com<br />
<strong>Bluestar</strong> <strong>Silicones</strong> France SAS<br />
21, avenue Georges Pompidou<br />
F-69486 Lyon Cedex 03 - France<br />
Tel. : +33 (0)4 72 13 19 00 - Fax : +33 (0)4 72 13 19 88<br />
Typical applications for <strong>Bluestar</strong> <strong>Silicones</strong>’ Silbione ® fl uids and dispersions<br />
include lubricious or hydrophobic coatings and demolding.<br />
Silbione ® Simethicone may be used for defoaming applications.<br />
Systemic Toxicity<br />
Intracutaneous Tox<br />
Viscosity (cps)<br />
Mutagenicity<br />
% Solids<br />
4500 35 Platinum 1,10 40 12 800 33<br />
Teratology<br />
Cure System<br />
800 40 Acetoxy 1,08 24 6.9 1000 28<br />
28-Day implant<br />
Specifi c Gravity<br />
90-Day Implant<br />
Durometer, ShA<br />
Tensile, MPa<br />
2-year Chronic Toxicity<br />
Elongation, %<br />
The information contained in this document is given in good faith and based on <strong>Bluestar</strong> <strong>Silicones</strong> current knowledge.<br />
<strong>Bluestar</strong> <strong>Silicones</strong> makes no representation or warranty as to the accuracy, completeness of such information<br />
or as to the compatibility of such information with the user’s intended application : information is supplied on an<br />
“as-is” basis and is not binding on <strong>Bluestar</strong> <strong>Silicones</strong>. Nothing contained herein is intended as a recommendation<br />
to use the products so as to infringe any patent.<br />
<strong>Bluestar</strong> <strong>Silicones</strong> assumes no liability for users’ violation of patent or other rights and disclaims any liability for loss,<br />
injury or damage which may result from the use of the products. Therefore, information contained herein must not<br />
be used as a substitute for necessary prior tests which are the sole responsibility of the user and which alone can<br />
ensure that a product is suitable for a given use.<br />
Silbione ® is a registered trademark of <strong>Bluestar</strong> <strong>Silicones</strong>.<br />
©2009 <strong>Bluestar</strong> <strong>Silicones</strong>. All rights reserved.<br />
Tear Strength, kN/m<br />
SIL 09 006 3-1 MED1 pemaco - Photos: Shutterstock: JCElv, <strong>Bluestar</strong> <strong>Silicones</strong><br />
<strong>Medical</strong> <strong>Devices</strong><br />
<strong>Manufacturing</strong> - 1<br />
Trouble-Free Molding and Easy Release<br />
With High Performance Properties<br />
<strong>Bluestar</strong> <strong>Silicones</strong> is designed specifi cally to meet<br />
the diverse and demanding needs of the medical<br />
device market. Combining the expertise of its<br />
designers, engineers and production experts,<br />
<strong>Bluestar</strong> <strong>Silicones</strong> continuously innovates and<br />
improves products to better match customer<br />
needs and meet the growing demands<br />
of the medical device market.<br />
From balloon catheters to wound drains to needle-less<br />
valves, to peristaltic pump tubing, to respiratory masks,<br />
to device coatings, <strong>Bluestar</strong> <strong>Silicones</strong> has the silicones<br />
solution to meet your need.<br />
<strong>Bluestar</strong> offers a complete range of Silbione ® silicone<br />
technologies for medical devices including Liquid<br />
Silicone Rubber (LSR), Heat Cured Rubber (HCR), RTV<br />
Adhesives, Specialty Fluids and Dispersions to meet<br />
your specifi c need.<br />
<strong>Bluestar</strong> <strong>Silicones</strong>. Delivering Your Potential.
SILBIONE ® LSR<br />
<strong>Medical</strong> <strong>Devices</strong><br />
<strong>Manufacturing</strong><br />
The best in class tailor<br />
made technology<br />
Silbione ® Product Typical Applications Typical Properties<br />
LSR 4305 A/B PEX<br />
Orthopedic insoles and cushioning;<br />
prosthetic liners; rollers<br />
5 3,1 1100 10 1,07<br />
(Viscosity<br />
= 40k cps)<br />
LSR 4310 A/B PEX Cushioning 10 5,1 1090 20 1,08 270 clear<br />
LSR 4325 A/B PEX Balloons 23 8,2 950 29 1,12 130 clear<br />
LSR 4330 A/B Molded healthcare & medical parts