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DSM Biomedical CarboSil® 20 80A Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

Category Polymer , Thermoplastic , Polycarbonate (PC) , Polyurethane, TP , Silicone Polyurethane, Polycarbonate Based
Manufacturer DSM Biomedical
Trade Name CarboSil®
Port Shanghai port,China
Trade Terms FOB, CFR, CIF
Payment Terms L/C, T/T, Western Union
Download PDF DSM Biomedical CarboSil® 20 80A Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU).pdf
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Material Notes:
A ground-breaking copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes The silicone portion of CarboSil® TSPCU works synergistically with the polycarbonate component to improve stability. This medical grade polymer is highly biocompatible and well suited to be used in many types of medical devices. Flexible CarboSil® TSPCU is comparable in tensile strength to traditional polycarbonate urethanes and derives additional biostability from the silicone portion. The material is adaptable to various fabrication techniques to accommodate many different device shapes. It can be extruded, injection or compression molded, solvent bonded, dipped coated and sprayed. Widely Used Because of its tensile strength, biocompatibility and flexibility, CarboSil® TSPCU is used in a wide range of medical applications, including cardiovascular and nervous system electrostimulation, continuous glucose monitoring, drug eluting and orthopedic implants. Tailor Made CarboSil® TSPCU can be enhanced with SME® technology to incorporate end groups that can address the needs of specific device applications (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 Thromboresistant Enhanced with SME® technology Comprehensive FDA Master File Grade denotes silicone content (%) Information provided by DSM Biomedical.
Physical Properties Metric English Comments
Specific Gravity 1.16 g/cc
1.16 g/cc
ASTM D792
Melt Flow 52 g/10 min

@Load 2.16 kg,
Temperature 224 °C
52 g/10 min

@Load 4.76 lb,
Temperature 435 °F
ASTM D1238
Mechanical Properties Metric English Comments
Hardness, Shore A 80
80
ASTM D2240
Tensile Strength, Ultimate 35.05 MPa
5084 psi
ASTM D1708
Tensile Strength, Yield 4.85 MPa

@Strain 50.0 %
704 psi

@Strain 50.0 %
ASTM D1708
6.52 MPa

@Strain 100 %
945 psi

@Strain 100 %
ASTM D1708
17.12 MPa

@Strain 300 %
2483 psi

@Strain 300 %
ASTM D1708
Elongation at Break 473 %
473 %
ASTM D1708
Thermal Properties Metric English Comments
Glass Transition Temp, Tg -7.00 °C
19.4 °F
ASTM D3418
Processing Properties Metric English Comments
Processing Temperature 190 - 210 °C
374 - 410 °F
Optimum Extrusion Conditions
Descriptive Properties Value Comments
26 week Carcinogenicity Study in the Transgenic ras H2 Mouse Model No increase in induced tumor formation
Chronic Toxicity, Subcutaneous Implant No evidence of systemic toxicity
Color Clear to Amber Pellets
Cytotoxicity No evidence of causing cell lysis or toxicity
Genotoxicity: Bacterial Reverse Mutation (95% ethanol extract) Non-mutagenic
Genotoxicity: Bacterial Reverse Mutation (saline extract) Non-mutagenic
Genotoxicity: In Vitro Chromosomal Aberration Non-genotoxic
Hemolysis Non-hemolytic
ISO Intracutaneous Irritation No evidence of significant irritation
ISO Maximization Sensitization No evidence of causing delayed dermal contact sensitization
Mouse Bone Marrow Micronucleus Non-genotoxic
Muscle Implantation, 12 weeks Non-irritant
Muscle Implantation, 2 weeks Non-irritant
USP and ISO Systemic Toxicity No evidence of systemic toxicity
USP Pyrogen Study Non-pyrogenic
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