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  • ASTM F 648 : 2014 : REDLINE

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

    Available format(s):  PDF

    Superseded date:  03-05-2021

    Language(s):  English

    Published date:  01-03-2014

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Specifies Ultra-High Molecular Weight Polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.

    Scope - (Show below) - (Hide below)

    1.1This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.

    1.2The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.

    1.3The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.

    1.4The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6).

    1.5The values stated in SI units are to be regarded as standard.

    1.6The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: This 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 Redline
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 763 : 2004 : R2010 Standard Practice for Short-Term Screening of Implant Materials
    BS 3531-20:1986 Surgical implants Specification for ultra-high molecular mass polyethylene in powder form
    BS ISO 5834-3:2005 Implants for surgery. Ultra-high-molecular-weight polyethylene Accelerated ageing methods
    CSA ISO 10993-12 : 98(R2002) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SAMPLE PREPARATION AND REFERENCE MATERIALS
    ASTM F 2665 : 2009 Standard Specification for Total Ankle Replacement Prosthesis
    ASTM F 1715 : 2000 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices
    ASTM F 1408 : 1997 : R2002 : EDT 1 Standard Practice for Subcutaneous Screening Test for Implant Materials
    ASTM F 1357 : 2014 : REDLINE Standard Specification for Articulating Total Wrist Implants
    ASTM F 2665 : 2009 : R2014 Standard Specification for Total Ankle Replacement Prosthesis
    ASTM F 1714 : 1996 : R2008 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
    NBR 15752-1 : 2015 IMPLANTS FOR ORTHOPEDICS - SHOULDER PROSTHESIS - PART 1: SPECIFICATIONS
    NBR 15719 : 2016 IMPLANTS FOR ORTHOPEDICS - HIP JOINT PROSTHESES - SPECIFICATION FOR ACETABULAR PROSTHESES
    NBR 15744-3 : 2013 IMPLANTS FOR SURGERY - TEST METHODS FOR ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE (UHMWPE) CHARACTERIZATION - PART 3: EVALUATING TRANS-VINYLENE YIELD IN IRRADIATED COMPONENTS BY INFRARED SPECTROSCOPY
    BS ISO 5834-2:2011 Implants for surgery. Ultra-high-molecular-weight polyethylene Moulded forms
    ASTM F 2224 : 2009 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ISO 5834-5:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method
    ASTM F 981 : 2004 : R2010 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
    ASTM F 1408 : 1997 : R2013 Standard Practice for Subcutaneous Screening Test for Implant Materials
    DIN ISO 5834-2:2014-02 IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS (ISO 5834-2:2011)
    ASTM F 1672 : 2014 : REDLINE Standard Specification for Resurfacing Patellar Prosthesis
    ASTM F 981 : 2004 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
    ASTM F 1814 : 2015 : REDLINE Standard Guide for Evaluating Modular Hip and Knee Joint Components
    ASTM F 755 : 1999 : EDT 1 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
    ASTM F 2565 : 2013 : REDLINE Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
    NF ISO 5834-2 : 2006 IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS
    ASTM F 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ASTM F 982 : 1986 : R2002 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
    ASTM F 732 : 2017 : REDLINE Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 763 : 2004 Standard Practice for Short-Term Screening of Implant Materials
    ASTM F 1714 : 1996 : R2002 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
    ASTM F 2759 : 2011 : REDLINE Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
    ASTM F 2003 : 2002 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    ASTM F 1408 : 1997 : R2008 Standard Practice for Subcutaneous Screening Test for Implant Materials
    ASTM F 981 : 2004 : R2016 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
    ASTM F 2091 : 2015 : REDLINE Standard Specification for Acetabular Prostheses
    ASTM F 755:1999 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
    04/30031040 DC : 0 ISO 5834-3 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 3: ACCELERATED AGEING METHODS
    ISO 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms
    04/30099319 DC : DRAFT APR 2004 ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD
    17/30360581 DC : 0 BS ISO 5834-2 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 2: MOULDED FORMS
    ASTM F 755 : 1999 : R2005 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
    ASTM F 982 : 1986 : R1998 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
    ASTM F 982 : 1986 : R2008 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
    ASTM F 763 : 2004 : R2016 Standard Practice for Short-Term Screening of Implant Materials
    ASTM F 1408 : 1997 Standard Practice for Subcutaneous Screening Test for Implant Materials
    ASTM F 2695 : 2012 : REDLINE Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
    ISO 5834-3:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 3: Accelerated ageing methods
    BS ISO 5834-5:2005 Implants for surgery. Ultra-high molecular weight polyethylene Morphology assessment method
    ASTM F 755 : 1999 : R2011 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
    ASTM PS 5 : 1994 Test Method for Static and Dynamic Test Method for Spinal Implants Assembly in a Corpectomy Model (Withdrawn 1997)
    ASTM F 2003 : 2002 : R2015 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    17/30360590 DC : 0 BS ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD
    ASTM F 1714 : 1996 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
    ASTM F 2887 : 2017 : REDLINE Standard Specification for Total Elbow Prostheses
    ASTM F 1714 : 1996 : R2013 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
    ASTM F 2183 : 2002 Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
    ASTM F 2003 : 2002 : R2008 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    ASTM F 2183 : 2002 : R2008 Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
    ASTM F 2083 : 2012 : REDLINE Standard Specification for Knee Replacement Prosthesis

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

    ISO 3451-1:2008 Plastics Determination of ash Part 1: General methods
    ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
    ISO 11542-2:1998 Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ASTM F 749 : 2013 : REDLINE Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    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
    ISO 9001:2015 Quality management systems — Requirements
    ASTM D 648 : 2016 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
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