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    ASTM F2977 - 20

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

    Active Standard ASTM F2977 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.02

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    Significance and Use

    4.1 Miniature specimen testing techniques are used to characterize the mechanical behavior of polymer stock materials and surgical implants after manufacture, sterilization, shelf aging, radiation crosslinking, thermal treatment, filler incorporation, and implantation (1-3). Furthermore, experimental materials can be evaluated after accelerated aging, fatigue testing, and hip, knee, or spine wear simulation. Consequently, the small punch test makes it possible to examine relationships between wear performance and mechanical behavior. This test method can also be used to rank the mechanical behavior relative to a reference control material.

    4.2 Small punch testing results may vary with specimen preparation and with the speed and environment of testing. Consequently, where precise comparative results are desired, these factors must be carefully controlled.

    1. Scope

    1.1 This test method covers the determination of mechanical behavior of polymeric biomaterials by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter). The test method has been established for characterizing surgical materials after ram extrusion or compression molding (1-3)2; for evaluating as-manufactured implants and sterilization method effects (4, 5); as well as for testing of implants that have been retrieved (explanted) from the human body (6, 7).

    1.2 The results of the small punch test, namely the peak load, ultimate displacement, ultimate load, and work to failure, provide metrics of the yielding, ultimate strength, ductility, and toughness under multiaxial loading conditions. Because the mechanical behavior can be different when loaded under uniaxial and multiaxial loading conditions (8), the small punch test provides a complementary mechanical testing technique to the uniaxial tensile test. However, it should be noted that the small punch test results may not correlate with uniaxial tensile test results.

    1.3 In addition to its use as a research tool in implant retrieval analysis, the small punch test can be used as a laboratory screening test to evaluate new materials with minimal material waste (1).

    1.4 The small punch test has been applied to other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), and polyetheretherketone (PEEK) (2, 3, 5, 9, 10). This standard outlines general guidelines for the small punch testing of implantable polymers.

    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.

    ASTM Standards

    D695 Test Method for Compressive Properties of Rigid Plastics

    D883 Terminology Relating to Plastics

    E4 Practices for Force Verification of Testing Machines

    E83 Practice for Verification and Classification of Extensometer Systems

    E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods

    E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

    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

    F2102 Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for 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/F2977-20

    Citation Format

    ASTM F2977-20, Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants, ASTM International, West Conshohocken, PA, 2020, www.astm.org

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