Biocompatibilitydata

HelixMark™ Silicone Tubing
Choice of Four Silicone Materials:

Dow Corning Silastic®, Wacker Silicones Corporation,
General Electric Company or NuSil Technology
Biomedical/Pharmaceutical Grade Platinum-Cured Silicone

HelixMark™ Biomedical/Pharmaceutical grade silicone tubing is offered in a full range of competitive sizes for standard, close tolerance or peristaltic pump applications. All of our tubing offerings are platinum-cured, containing no additives, plasticizers or peroxide components. The tubing is nonadherent and resists clotting, sticking or encrustation. With an indefinite shelf life and able to operate at elevated temperatures, it will not oxidize or deteriorate. Rigorous testing, including expanded biocompatibility, provides quality assurance for the most demanding Biomedical/Pharmaceutical industry standards. All HelixMark™ tubing meets USP Class Vl-XXIII biocompatibility requirements. Helix Medical, Inc.’s proprietary manufacturing process within our medical device facility maximizes our ability to deliver the highest quality tubing that will meet your exacting specifications. Choose from Dow Corning Silastic®, Wacker Silicones Corporation, General Electric Company or NuSil Technology platinum-cured elastomers for standard, close tolerance or pumping applications.
All HelixMark™ platinum-cured silicone tubing is manufactured in our FDA registered medical device facility, following Good Manufacturing Practices (GMPs) in accordance with the Quality System Regulation. Helix Medical, Inc. has been certified to meet ISO 9001/EN 46001 quality standards. Custom sizes and/or materials are available on request.
TESTS PERFORMEDDOW CORNING
SILASTIC®
WACKER
SILICONES
NUSIL
TECH.
GE
SILICONE
Hemolysis, PercentYesYesYesYes
PyrogenicityYesYesYesYes
Intracutaneous InjectionYesYesYesYes
Systemic InjectionYesYesYesYes
Intramuscular Implant-90 daysYesYesYesYes
Cytotoxicity: MEM ElutionYesYesYesYes
Cytotoxicity: Agarose OverlayYesYesYesYes
Heavy MetalsYesYesYesN/A
Physio-Chemical Tests: Non-volatile ResidueN/AYesN/AN/A
Physio-Chemical Tests: Residue on IgnitionN/AYesN/AN/A
Physio-Chemical Tests: Buffering CapacityN/AYesN/AN/A
Infrared AnalysisN/AYesN/AN/A