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DSM Biomedical PurSil® 35 Thermoplastic Silicone Polyether Polyurethane (TSPU)

Category Polymer , Thermoplastic , Polyurethane, TP , Silicone Polyurethane, Ether Based
Manufacturer DSM Biomedical
Trade Name PurSil®
Port Shanghai port,China
Trade Terms FOB, CFR, CIF
Payment Terms L/C, T/T, Western Union
Download PDF DSM Biomedical PurSil® 35 Thermoplastic Silicone Polyether Polyurethane (TSPU).pdf
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Material Notes:
A novel copolymer that is strong yet flexible with proven biocompatibility and biostability Combining the benefits of both silicone elastomers and polyether urethanes, PurSil® TSPU has exceptional stability. Flexible PurSil® TSPU is comparable in tensile strength to traditional polyether urethanes with added biostability from the silicone component. It is adaptable to various fabrication techniques to accommodate many different device shapes and can be extruded, injection or compression molded, solvent bonded, dipped coated and sprayed. This highly flexible polymer is available in aromatic and aliphatic versions. Widely Used Because of its outstanding flexibility, oxidative stability and thromboresistance, PurSil® TSPU is used in a wide range of medical devices, including ophthalmic, anastomotic, and continuous glucose monitoring. Tailor Made PurSil® TSPU can be enhanced with SME® technology to incorporate end groups such as fluorocarbon and/or polyethylene oxide (silicone end groups are standard). This eliminates the need for additional surface processing steps after the device component is fabricated. Summary of Product Benefits Biostable and biocompatible Adaptable to many different processing techniques Excellent mechanical properties relative to conventional silicone elastomers Thromboresistant Enhanced with SME® technology utilizing various surface modifying end groups Comprehensive FDA Master File Grade denotes silicone content (%) Information provided by DSM Biomedical.
Physical Properties Metric English Comments
Specific Gravity 1.11 g/cc
1.11 g/cc
ASTM D792
Linear Mold Shrinkage 0.011 cm/cm
0.011 in/in
4.0 inch Disk; ASTM D955
Linear Mold Shrinkage, Transverse 0.0080 - 0.019 cm/cm
0.0080 - 0.019 in/in
Flame Bar; ASTM D955
Melt Flow 32 g/10 min

@Load 1.20 kg,
Temperature 224 °C
32 g/10 min

@Load 2.65 lb,
Temperature 435 °F
ASTM D1238
Mechanical Properties Metric English Comments
Hardness, Shore A 83
83
ASTM D2240
Tensile Strength, Ultimate 25.26 MPa
3664 psi
ASTM D1708
Tensile Strength, Yield 4.67 MPa

@Strain 50.0 %
677 psi

@Strain 50.0 %
ASTM D1708
6.32 MPa

@Strain 100 %
916 psi

@Strain 100 %
ASTM D1708
13.07 MPa

@Strain 300 %
1896 psi

@Strain 300 %
ASTM D1708
Elongation at Break 492 %
492 %
ASTM D1708
Flexural Strength 1.86 MPa
270 psi
at 5% deflection; ASTM D790
Flexural Modulus 0.0433 GPa
6.28 ksi
1% Secant Modulus; ASTM D790
Tear Strength 57.8 kN/m
330 pli
Die 'C'; ASTM D624
Taber Abrasion, mg/1000 Cycles 85
85
H-18 Wheel; ASTM D1044
Compression Set 29 %

@Temperature 25.0 °C
29 %

@Temperature 77.0 °F
22 hours; ASTM D395
Thermal Properties Metric English Comments
CTE, linear 193.5 µm/m-°C

@Temperature 20.0 °C
107.5 µin/in-°F

@Temperature 68.0 °F
ASTM E-831
Vicat Softening Point 67.0 °C
153 °F
ASTM D1525
Glass Transition Temp, Tg -12.0 °C
10.4 °F
ASTM D3418
Electrical Properties Metric English Comments
Dielectric Constant 5.8

@Frequency 60 Hz
5.8

@Frequency 60 Hz
ASTM D150
Dielectric Strength 16.5 kV/mm
420 kV/in
ASTM D149
Processing Properties Metric English Comments
Processing Temperature 182 - 204 °C
360 - 399 °F
Optimum Extrusion Conditions
Descriptive Properties Value Comments
Color Clear to Amber Pellets
Cytotoxicity (1X MEM Elution) Non-cytotoxic
Genotoxicity: Bacterial Reverse Non-mutagenic
Genotoxicity: in vitro Non-genotoxic
In Vitro Hemolysis Study Non-hemolytic
ISO Intracutaneous No evidence of significant irritation from
ISO Maximization Sensitization No evidence of causing delayed dermal
ISO Rabbit Pyrogen Non-pyrogenic
Mouse Bone Marrow No evidence of cellular toxicity
Plasma Recalcification Time No significant effect on recalcification time
Subchronic Intravenous Toxicity No significant evidence of systemic
USP and ISO Systemic Toxicity No mortality or evidence of significant
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