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Ensinger PEI

DSM Biomedical Bionate® 65D 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 1.22 g/cc1.22 g/ccASTM D792
    Melt Flow 10 g/10 min
    @Load 2.16 kg,
    Temperature 224 °C
    10 g/10 min
    @Load 4.76 lb,
    Temperature 435 °F
    ASTM D1238
     
    Mechanical PropertiesMetricEnglishComments
    Hardness, Shore D 6666ASTM D2240
    Tensile Strength, Ultimate 62.16 MPa9015 psiASTM D1708
    Tensile Stress at Strain  25.39 MPa
    @Strain 50 %
    3683 psi
    @Strain 50 %
    ASTM D1708
     31.72 MPa
    @Strain 100 %
    4601 psi
    @Strain 100 %
    ASTM D1708
    Elongation at Break 281 %281 %ASTM D1708
     
    Processing PropertiesMetricEnglishComments
    Processing Temperature 190 - 220 °C374 - 428 °FOptimum Extrusion
     
    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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