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DSM Biomedical BioSpan® S SPU Segmented Polyether Polyurethane (SPU)

Category Polymer , Thermoplastic , Polyurethane, TP , Thermoplastic Polyurethane (TPUR), Polyether Grade
Manufacturer DSM Biomedical
Trade Name BioSpan®
Port Ningbo port,China
Trade Terms FOB, CFR, CIF
Payment Terms L/C, T/T, Western Union
Download PDF DSM Biomedical BioSpan® S SPU Segmented Polyether Polyurethane (SPU).pdf
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Material Notes:
The flex life exhibited by BioSpan® SPU enables good performance in many different types of medical devices. This elastomeric polymer has shown the ability to withstand millions of flex cycles.The combination of properties inspires exceptional devices In addition to excellent flex life, BioSpan® SPU offers a combination of additional properties, including low modulus, high tensile strength, high elongation, proven biocompatibility and good biostability. Because of these properties, it is used in ventricular assist devices as well as in artificial hearts, interventional cardiology balloons, drug eluting stents and spinal implants. Tailor Made BioSpan® SPU can be enhanced with SME® technology to incorporate different surface active end groups such as silicone and fluorocarbon. SME® technology eliminates the need for additional surface modification steps after the device component is fabricated.Summary of Product Benefits Excellent flex life Outstanding mechanical strength Hydrolytically stable Extremely elastic Biocompatible Adaptable with SME® technology Comprehensive FDA Master File Information provided by DSM Biomedical.
Physical Properties Metric English Comments
Water Absorption 1.08 %
1.08 %
ASTM D570
Mechanical Properties Metric English Comments
Tensile Strength, Ultimate 38.6 MPa
5600 psi
ASTM D1708
Elongation at Break 847 %
847 %
ASTM D1708
Modulus of Elasticity 0.01037 GPa
1.504 ksi
initial; ASTM D1708
Coefficient of Friction 6.4
6.4
ASTM D1894
Descriptive Properties Value Comments
Ames Mutagenicity Assay Non-mutagenic
Appearance Translucent
Balb/c-3T3 Cell Transformation Does not induce morphological cell transformation in activated or non-activated test systems
Chromosome Aberration Non-genotoxic
Contact Angle (°) 94
Hemolysis Non-hemolytic
Intracutaneous Injection Non-toxic
Kligman’s Maximization-CSO extract Weak allergic potential
Kligman’s Maximization-NaCl extract Weak allergic potential
Lee White Clotting No effect on the clotting time of whole blood
Primary Mucosal Non-irritant
Primary Skin Non-irritant
Repeat Dose IV Study Non-toxic
Solution Concentration by Weight (%) 20
USP Acute Systemic Non-toxic
USP Cytotoxicity (MEM Elution) Non-cytotoxic
USP Muscle Implantation (120 days/rats) Macroscopic-not significant tissue contact irritation, Microscopic-slight irritant
USP Muscle Implantation (14 days/rats) Macroscopic-not significant tissue contact irritation, Microscopic-Non-irritant
USP Pyrogen Non-pyrogenic
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