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    ASTM F648 - 21

    Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

    Active Standard ASTM F648 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.01


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    Abstract

    This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) powder and fabricated forms for use in surgical implants. UHMWPE powder shall be of virgin polymer manufactured from a homopolymer of ethylene, while the fabricated forms shall be manufactured from the same UHMWPE powder without any stabilizers or processing aids. Tests for viscosity number, elongation stress, ash content, extraneous matter, and trace elements shall be performed for UHMWPE powders, while tests for density, ash content, tensile strength, yield strength, elongation, and impact strength shall be performed for fabricated forms. All tests shall conform to the requirements specified.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

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

    1.2 The 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.

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

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

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

    1.6 The 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ISO Standards

    ISO 11542/2 PlasticsUltra-High Molecular Weight Polyethylene (UHMWPE) Moulding and Extrusion MaterialsPart 2: Preparation of Test Specimens and Determination

    ISO 13485 Medical DevicesQuality Management SystemsRequirements for Regulatory Purposes

    ISO 9001

    ASTM Standards

    D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

    D638 Test Method for Tensile Properties of Plastics

    D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

    D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

    D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

    D1505 Test Method for Density of Plastics by the Density-Gradient Technique

    D1898 Practice for Sampling of Plastics

    D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials

    F619 Practice for Extraction of Materials Used in Medical Devices

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

    F756 Practice for Assessment of Hemolytic Properties of Materials

    F763 Practice for Short-Term Screening of Implant Materials

    F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

    F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

    F2759 Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F0648-21

    Citation Format

    ASTM F648-21, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, ASTM International, West Conshohocken, PA, 2021, www.astm.org

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