ASTM F2759 - 19

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

    Active Standard ASTM F2759 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.02


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    Significance and Use

    4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders.

    4.2 This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.

    4.3 The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model.

    4.4 Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.

    4.5 Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.

    4.6 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review.

    (A) For materials terminally sterilized by gamma or e-beam irradiation.

    1. Scope

    1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.

    1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.

    1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.

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

    1.5 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.

    1.6 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 10993 Biological Evaluation of Medical Devices

    ISO 14242–1 Implants for SurgeryWear of Total Hip-Joint Prostheses. Part 1: Loading and Displacement Parameters for Wear-Testing Machines and Corresponding Environmental Conditions for Test

    ISO 14242–2

    ISO 14243–3 Implants for SurgeryWear of Total Knee-Joint Prostheses. Part 3: Loading and Displacement Parameters for Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test

    ISO 18192–1 Implants for SurgeryWear of Total Intervertebral Disc Prostheses. Part 1: Loading and Displacement Parameters for Wear Testing and Corresponding Environmental Conditions for Test

    ISO 3451–1 Plastics: Determination of Ash Part 1: General Methods

    ISO 527 Plastics: Determination of Tensile Properties

    ISO 5834–1 Implants for SurgeryUltra High Molecular Weight Polyethylene. Part 1: Powder Form

    ISO 5834–2

    ASTM Standards

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

    D638 Test Method for Tensile Properties of Plastics

    D695 Test Method for Compressive Properties of Rigid Plastics

    D883 Terminology Relating to Plastics

    D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics

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

    E647 Test Method for Measurement of Fatigue Crack Growth Rates

    F619 Practice for Extraction of Medical Plastics

    F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

    F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

    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

    F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

    F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices

    F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

    F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

    F2102 Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

    F2214 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

    F2381 Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

    F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

    F2625 Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry

    F2695 Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

    F2977 Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    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/F2759-19

    Citation Format

    ASTM F2759-19, Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices, ASTM International, West Conshohocken, PA, 2019, www.astm.org

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