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  • ASTM F 639 : 2009 : R2015

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    Standard Specification for Polyethylene Plastics for Medical 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)

    CONTAINED IN VOL. 13.01, 2015 Defines polyethylene plastics (as defined in Terminology D 883) intended for use in medical Device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices.

    Scope - (Show below) - (Hide below)

    1.1This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.

    1.2This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.

    1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.4This 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 Standard
    Product Note Reconfirmed 2015
    Publisher American Society for Testing and Materials
    Status Current

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

    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    ASTM D 671 : 1993 Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
    ASTM D 4976 : 2006 Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 1238 : 2013 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 4976 : 2000 : REV B Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 1238 : 2010 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 4976 : 2004 : REV A Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 4976 : 2004 Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1505 : 2003 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 4976 : 2012 Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 4976 : 2002 Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 1898 : 1968 : R1989 Standard Practice for Sampling of Plastics (Withdrawn 1998)
    ASTM E 117 : 1964 : R1989 Method for Spectrographic Analysis of Pig-Lead by the Point-To-Plane Technique (Withdrawn 1995)
    ASTM D 1238 : 2004 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1505 : 1968 : R1979 Standard Test Method for Density Of Plastics By The Density-Gradient Technique
    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 1505 : 2010 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 1505 : 2018 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 4976 : 2002 : EDT 1 Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
    ASTM D 1505 : 1998 : EDT 1 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 1238 : 2001 : EDT 1 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
    ASTM D 1238 : 2004 : REV A Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ASTM D 1238 : 1985 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 4976 : 2012 : REV A Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
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