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Ensinger PEI

DSM Biomedical Bionate® II 55D 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<\ul>

    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 0.54 %0.54 %ASTM D570
    Molecular Weight 231000 g/mol231000 g/molMw; GPC
    Linear Mold Shrinkage 0.0080 - 0.0231 cm/cm0.0080 - 0.0231 in/inASTM D955
    Melt Flow 35 g/10 min
    @Temperature 224 °C
    35 g/10 min
    @Temperature 435 °F
    ASTM D1238
     
    Mechanical PropertiesMetricEnglishComments
    Hardness, Shore D 5656ASTM D2240
    Tensile Strength at Break 61.8 MPa8960 psiASTM D1708
    Tensile Stress at Strain  13.29 MPa
    @Strain 50 %
    1927 psi
    @Strain 50 %
    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 MPa511 psiat 5% deflection; ASTM D790
    Flexural Modulus, 1% Secant 95.1 MPa13800 psiASTM D790
    Coefficient of Friction, Dynamic 0.460.46ASTM D1894
    Taber Abrasion, mg/1000 Cycles 1111H-18 wheel; ASTM D4060
     
    Electrical PropertiesMetricEnglishComments
    Dielectric Constant 3.71
    @Frequency 60 Hz
    3.71
    @Frequency 60 Hz
    k'; ASTM D150
    Dielectric Strength 16.5 kV/mm420 kV/inASTM D149
     
    Thermal PropertiesMetricEnglishComments
    Melting Point 180 °C356 °FASTM E1356
    Vicat Softening Point 106.9 °C224.4 °FASTM D1525
    Glass Transition Temp, Tg 1.00 °C33.8 °FASTM E1356
     
    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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