Medical Devices Manufacturing - 1 - Bluestar Silicones

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

SILBIONE ® LSR
Medical Devices
Manufacturing
The best in class tailor
made technology
Silbione ® Product Typical Applications Typical Properties
LSR 4305 A/B PEX
Orthopedic insoles and cushioning;
prosthetic liners; rollers
5 3,1 1100 10 1,07
(Viscosity
= 40k cps)
LSR 4310 A/B PEX Cushioning 10 5,1 1090 20 1,08 270 clear
LSR 4325 A/B PEX Balloons 23 8,2 950 29 1,12 130 clear
LSR 4330 A/B Molded healthcare & medical parts