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  • ASTM F 624 : 2009 : R2015 : EDT 1

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    Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-03-2015

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications.

    Scope - (Show below) - (Hide below)

    1.1This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.

    1.2The tests and methods listed in this guide may be referenced in specifications containing minimum required values and tolerances for specific end-use products.

    1.3Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

    1.4Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.

    1.5This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Guide
    Product Note Reconfirmed EDT 1
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 2240 : 2000 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM E 96/E96M : 2016 : REDLINE Standard Test Methods for Water Vapor Transmission of Materials
    ASTM D 2124 : 1999 : R2011 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique (Withdrawn 2020)
    ASTM D 1238 : 2000 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1238 : 2004 : REV C Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3137 : 1981 : R1994 Standard Test Method for Rubber Property—Hydrolytic Stability
    ASTM D 671 : 1993 Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
    ASTM D 3418 : 2012 : EDT 1 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 2857 : 1995 : R2001 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 3418 : 1982 : R1988 : EDT 1 Standard Test Method for Transition Temperatures of Polymers By Thermal Analysis
    ASTM D 150 : 2022 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
    ASTM D 1544 : 1998 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
    ASTM D 1434 : 1982 : R2003 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
    ASTM D 3418 : 1999 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
    ASTM D 2857 : 1995 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM E 96/E96M : 2022 : REV A Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
    ASTM D 1238 : 2013 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 3418 : 2021 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3137 : 1981 : R2013 Standard Test Method for Rubber Property—Hydrolytic Stability
    ASTM E 96/E96M : 2021 Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
    ASTM D 1238 : 2010 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 257 : 2014 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
    ASTM D 2240 : 2004 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM E 96/E96M : 2022 Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
    ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ASTM D 1544 : 2004 : R2018 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
    ASTM D 2990 : 2017 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 3418 : 2012 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3418 : 2003 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 2240 : 2004 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 3418 : 2015 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 2990 : 2001 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 3137 : 1981 : R2001 Standard Test Method for Rubber Property—Hydrolytic Stability
    ASTM D 2857 : 1995 : R2007 Standard Practice for Dilute Solution Viscosity of Polymers (Withdrawn 2016)
    ASTM D 2857 : 1970 : R1977 Standard Test Method for Dilute Solution Viscosity Of Polymers
    ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 1638 : 1974 : EDT 1 Methods of Testing Urethane Foam Isocyanate Raw Materials
    ASTM E 96/E96M : 2016 Standard Test Methods for Water Vapor Transmission of Materials
    ASTM D 2857 : 2022 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 1238 : 2004 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 2240 : 2015 : R2021 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 2990 : 2009 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 2990 : 1995 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 575 : 1991 : R1996 Standard Test Methods for Rubber Properties in Compression
    ASTM D 2240 : 2002 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM D 3137 : 1981 : R2018 Standard Test Method for Rubber Property—Hydrolytic Stability
    ASTM D 1434 : 1982 : R2015 : EDT 1 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
    ASTM D 2240 : 2015 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 2240 : 2003 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 3418 : 2008 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 1544 : 2004 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
    ASTM D 2240 : 2002 : REV B Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 1434 : 1982 : R2009 : EDT 1 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
    ASTM D 257 : 2014 : REDLINE Standard Test Methods for DC Resistance or Conductance of Insulating Materials
    ASTM D 570 : 2022 Standard Test Method for Water Absorption of Plastics
    ASTM D 2240 : 2015 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 1242 : 1995 : REV A Standard Test Methods for Resistance of Plastic Materials to Abrasion (Withdrawn 2004)
    ASTM D 1544 : 2004 : R2010 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
    ASTM D 1238 : 2001 : EDT 1 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 2124 : 1999 : EDT 1 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique
    ASTM D 3137 : 1981 : R2007 Standard Test Method for Rubber Property—Hydrolytic Stability
    ASTM D 2240 : 2005 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 150 : 2018 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
    ASTM D 1238 : 2004 : REV A Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 2240 : 2005 : R2010 Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
    ASTM D 2240 : 2002 : REV A Standard Test Method for Rubber Property—Durometer Hardness
    ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 257 : 2014 : R2021 : EDT 1 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
    ASTM D 1238 : 1985 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 2124 : 1999 : R2004 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique
    ASTM D 1434 : 1982 : R1998 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
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