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Ensinger PEI
DSM Biomedical Bionate® 55D 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:
    Available Properties
    • Specific Gravity, ASTM D792
    • Water Absorption, ASTM D750
    • Linear Mold Shrinkage, ASTM D955, 4.0 inch Disk
    • Linear Mold Shrinkage, Transverse, ASTM D955, Flame Bar
    • Melt Flow, ASTM D1238
    • Hardness, Shore D, ASTM D2240
    • Tensile Strength, Ultimate, ASTM D1708
    • Tensile Stress at Strain, ASTM D1708
    • Tensile Stress at Strain, ASTM D1708
    • Tensile Stress at Strain, ASTM D1708
    • Elongation at Break, ASTM D1708
    • 100% Modulus, ASTM D638
    • Flexural Strength, ASTM D790, at 5% deflection
    • Flexural Modulus, ASTM D790
    • Coefficient of Friction, ASTM D1894
    • Tear Strength, ASTM D624, Die 'C'
    • Taber Abrasion, mg/1000 Cycles, ASTM D1044, H-18 Wheel
    • Dielectric Constant, ASTM D150
    • Dielectric Strength, ASTM D149
    • CTE, linear, ASTM E-831
    • Vicat Softening Point, ASTM D1525
    • Processing Temperature, Optimum Extrusion Conditions
    • Rear Barrel Temperature
    • Middle Barrel Temperature
    • Front Barrel Temperature
    • Drying Temperature
    • Dry Time, to moisture < 0.05%
      
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    Manufacturer Notes:
    DSM Biomedical (Former Polymer Technology Group)

    Category Notes
    Plastic

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