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Ensinger PEI

DSM Biomedical Bionate® 90A Thermoplastic Polycarbonate Polyurethane (PCU)
Categories: Polymer; Thermoplastic; Polycarbonate (PC); 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
    Specific Gravity 1.20 g/cc1.20 g/ccASTM D792
    Linear Mold Shrinkage 0.012 cm/cm0.012 in/in4.0 inch Disk; ASTM D955
    Linear Mold Shrinkage, Transverse 0.00 - 0.030 cm/cm0.00 - 0.030 in/inFlame Bar; ASTM D955
    Melt Flow 14 g/10 min
    @Load 1.20 kg,
    Temperature 224 °C
    14 g/10 min
    @Load 2.65 lb,
    Temperature 435 °F
    ASTM D1238
     
    Mechanical PropertiesMetricEnglishComments
    Hardness, Shore A 9191ASTM D2240
    Tensile Strength, Ultimate 55.11 MPa7993 psiASTM D1708
    Tensile Stress at Strain  7.991 MPa
    @Strain 50 %
    1159 psi
    @Strain 50 %
    ASTM D1708
     11.06 MPa
    @Strain 100 %
    1604 psi
    @Strain 100 %
    ASTM D1708
     36.85 MPa
    @Strain 300 %
    5345 psi
    @Strain 300 %
    ASTM D1708
    Elongation at Break 406 %406 %ASTM D1708
    Flexural Strength 1.90 MPa275 psiat 5% deflection; ASTM D790
    Flexural Modulus 0.0416 GPa6.03 ksiASTM D790
    Tear Strength 96.4 kN/m550 pliDie 'C'; ASTM D624
    Taber Abrasion, mg/1000 Cycles 9.19.1H-18 Wheel; ASTM D1044
     
    Electrical PropertiesMetricEnglishComments
    Dielectric Constant 4.8
    @Frequency 60 Hz
    4.8
    @Frequency 60 Hz
    ASTM D150
    Dielectric Strength 18.9 kV/mm480 kV/inASTM D149
     
    Thermal PropertiesMetricEnglishComments
    CTE, linear 160.7 µm/m-°C
    @Temperature 20.0 °C
    89.28 µin/in-°F
    @Temperature 68.0 °F
    ASTM E-831
    Vicat Softening Point 88.0 °C190 °FASTM D1525
     
    Processing PropertiesMetricEnglishComments
    Processing Temperature 180 - 210 °C356 - 410 °FOptimum Extrusion Conditions
    Rear Barrel Temperature 200 - 215 °C392 - 419 °F
    Middle Barrel Temperature 193 - 230 °C379 - 446 °F
    Front Barrel Temperature 193 - 230 °C379 - 446 °F
    Drying Temperature 82.0 °C180 °F
    Dry Time >= 4 hour>= 4 hourto moisture < 0.05%
     
    Descriptive Properties
    Acute Systemic ToxicityNo significant systemic toxicity
    Ames MutagenicityNon-mutagenic
    Carcinogenicity: 2 years in ratsNon-carcinogenic
    Chronic Toxicity: USP MuscleMacroscopic reaction not significant
    ColorClear to Amber Pellets
    Complement ActivationLess activation of the complement system
    HemolysisNon-hemolytic
    Humoral Immunological StudyNo humoral (serological) immune
    Intracutaneous ToxicityNo significant irritation or toxicity
    Platelet Deposition (ex vivo shunt)No difference in thrombogenicity
    Sensitization: Magnusson andNo dermal sensitization
    USP Cytotoxicity (MEM Elution)Non-cytotoxic
    USP Implantation Test: 7 daysMacroscopic reaction not significant
    USP PyrogenicityNon-pyrogenic

    Some of the values displayed above may have been converted from their original units and/or rounded in order to display the information in a consistent format. Users requiring more precise data for scientific or engineering calculations can click on the property value to see the original value as well as raw conversions to equivalent units. We advise that you only use the original value or one of its raw conversions in your calculations to minimize rounding error. We also ask that you refer to MatWeb's terms of use regarding this information. Click here to view all the property values for this datasheet as they were originally entered into MatWeb.

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