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Ensinger PEI

DSM Biomedical Bionate® II 90A Thermoplastic Polycarbonate Polyurethane (PCU)
Categories: Polymer; Thermoplastic; Polyurethane, TP; Polycarbonate-Urethane

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 Benefits

  • Biostable 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.

  • Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
     
    Physical PropertiesMetricEnglishComments
    Water Absorption 0.72 %0.72 %ASTM D570
    Molecular Weight 262000 g/mol262000 g/molMw; GPC
    Linear Mold Shrinkage 0.0083 - 0.0271 cm/cm0.0083 - 0.0271 in/inASTM D955
    Melt Flow 18 g/10 min
    @Temperature 224 °C
    18 g/10 min
    @Temperature 435 °F
    ASTM D1238
     
    Mechanical PropertiesMetricEnglishComments
    Hardness, Shore A 9292ASTM D2240
    Tensile Strength at Break 59.40 MPa8615 psiASTM D1708
    Tensile Stress at Strain  9.363 MPa
    @Strain 50 %
    1358 psi
    @Strain 50 %
    ASTM D1708
     13.16 MPa
    @Strain 100 %
    1909 psi
    @Strain 100 %
    ASTM D1708
     44.94 MPa
    @Strain 300 %
    6518 psi
    @Strain 300 %
    ASTM D1708
    Elongation at Break 385 %385 %ASTM D1708
    Flexural Yield Strength 2.16 MPa314 psiat 5% deflection; ASTM D790
    Flexural Modulus, 1% Secant 45.1 MPa6540 psiASTM D790
    Coefficient of Friction, Dynamic 0.430.43ASTM D1894
     
    Electrical PropertiesMetricEnglishComments
    Dielectric Constant 3.97
    @Frequency 60 Hz
    3.97
    @Frequency 60 Hz
    k'; ASTM D150
    Dielectric Strength 16.7 kV/mm423 kV/inASTM D149
     
    Thermal PropertiesMetricEnglishComments
    Melting Point 177 °C351 °FASTM E1356
    Vicat Softening Point 94.7 °C202 °FASTM D1525
    Glass Transition Temp, Tg -2.00 °C28.4 °FASTM E1356
     
    Processing PropertiesMetricEnglishComments
    Processing Temperature 180 - 210 °C356 - 410 °FExtrusion
     225 - 230 °C437 - 446 °FInjection
     
    Descriptive Properties
    ColorClear to Amber Pellets
    CytotoxicityNon-cytotoxic
    GenotoxicityNon-mutagenic
    HemocompatibilityNon-hemolytic
    ImplantationNon-irritant
    IrritationNo significant irritation or toxicity
    PyrogenicityNon-pyrogenic
    SensitizationNo evidence of sensitization; not considered a sensitizer
    Systemic ToxicityNo evidence of systemic toxicity

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