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DSM Biomedical Bionate® II 55D Thermoplastic Polycarbonate Polyurethane (PCU)

Category Polymer , Thermoplastic , Polyurethane, TP , Polycarbonate-Urethane
Manufacturer DSM Biomedical
Trade Name Bionate® II
Port Shanghai port,China
Trade Terms FOB, CFR, CIF
Payment Terms L/C, T/T, Western Union
Download PDF DSM Biomedical Bionate® II 55D Thermoplastic Polycarbonate Polyurethane (PCU).pdf
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Material Notes:
A proven family of highly biocompatible medical grade polymers with outstanding physical and mechanical properties Bionate® PCU is a medical grade polymer for use in long-term implants. It has been used in chronically implanted medical devices for nearly two decades. The Bionate® PCU family is one of the most extensively tested families of biomedical polymers and is backed by a comprehensive FDA Master File. Both Bionate® PCU and Bionate® II PCU are tough, biostable and biocompatible polymers with exceptional performance characteristics. Widely Used The Bionate® PCU family is currently being used in a wide range of applications, including neurostimulation, vascular, artificial heart, cardiac assist and diagnostic devices. Because of its exceptional load-bearing capability and biostability, it is also used extensively in orthopedic applications such as hip and knee joints and spinal motion preservation devices. Due to its biostability, flexibility, electrical properties and tensile strength, the Bionate® PCU family is an excellent candidate for lead insulation. Tailor Made Bionate® PCU can be modified with SME® technology to incorporate end groups that can enhance device performance. Bionate® II PCU also offers a wide range of potential surface characteristics by using DSM’s patented SAME® technology. Summary of Product BenefitsBiostable and biocompatible Extensively tested Backed by a comprehensive FDA Master File In use for nearly two decades Exceptional abrasion resistance, flexibility and tensile strength Adaptable with SME® and SAME® technology Information provided by DSM Biomedical.
Physical Properties Metric English Comments
Water Absorption 0.54 %
0.54 %
ASTM D570
Molecular Weight 231000 g/mol
231000 g/mol
Mw; GPC
Linear Mold Shrinkage 0.0080 - 0.0231 cm/cm
0.0080 - 0.0231 in/in
ASTM D955
Melt Flow 35 g/10 min

@Temperature 224 °C
35 g/10 min

@Temperature 435 °F
ASTM D1238
Mechanical Properties Metric English Comments
Hardness, Shore D 56
56
ASTM D2240
Tensile Strength at Break 61.8 MPa
8960 psi
ASTM D1708
Tensile Strength, Yield 13.29 MPa

@Strain 50.0 %
1927 psi

@Strain 50.0 %
ASTM D1708
18.17 MPa

@Strain 100 %
2635 psi

@Strain 100 %
ASTM D1708
48.99 MPa

@Strain 300 %
7105 psi

@Strain 300 %
ASTM D1708
Elongation at Break 372 %
372 %
ASTM D1708
Flexural Yield Strength 3.52 MPa
511 psi
at 5% deflection; ASTM D790
Flexural Modulus, 1% Secant 95.1 MPa
13800 psi
ASTM D790
Coefficient of Friction, Dynamic 0.46
0.46
ASTM D1894
Taber Abrasion, mg/1000 Cycles 11
11
H-18 wheel; ASTM D4060
Thermal Properties Metric English Comments
Melting Point 180 °C
356 °F
ASTM E1356
Vicat Softening Point 106.9 °C
224.4 °F
ASTM D1525
Glass Transition Temp, Tg 1.00 °C
33.8 °F
ASTM E1356
Electrical Properties Metric English Comments
Dielectric Constant 3.71

@Frequency 60.0 Hz
3.71

@Frequency 60.0 Hz
k'; ASTM D150
Dielectric Strength 16.5 kV/mm
420 kV/in
ASTM D149
Descriptive Properties Value Comments
Color Clear to Amber Pellets
Cytotoxicity Non-cytotoxic
Genotoxicity Non-mutagenic
Hemocompatibility Non-hemolytic
Implantation Non-irritant
Irritation No significant irritation or toxicity
Pyrogenicity Non-pyrogenic
Sensitization No evidence of sensitization; not considered a sensitizer
Systemic Toxicity No evidence of systemic toxicity
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