ASTM F2345 - 03(2013)

    Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

    Active Standard ASTM F2345 | Developed by Subcommittee: F04.22

    Book of Standards Volume: 13.01

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    Significance and Use

    4.1 These test methods can be used to determine the effects of head and cone materials, design variables, manufacturing, and other conditions on the static and cyclic load-carrying ability of modular femoral heads mounted on the cones of femoral stem prostheses.

    4.2 These test methods may use actual femoral prostheses or neck-cone models of simplified geometry with the same geometrical and material characteristics as in the implants. In either case, the matching metallic cone region of the test specimen selected shall be of the same material, tolerances, and finishing as the final femoral stem prosthesis.

    4.3 The static test data may yield valuable information about the relative strengths and merits of different head and cone designs for particular applications. Due to the high forces anticipated for this type of destructive test (>40 kN), the boundary conditions and load levels far exceed possible in vivo loading parameters and therefore may not necessarily be applicable as a quantitative indicator of expected in vivo device performance.

    4.4 In the fatigue test methods, it is recognized that actual loading in vivo is quite varied, and that no one set of experimental conditions can encompass all possible variations. Thus, the test methods included here represent a simplified model for the purposes of comparisons between designs and materials. These test methods are intended to be performed in air.

    4.5 The test data may yield valuable information about the relative strengths of different head and cone designs.

    1. Scope

    1.1 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.

    1.2 These test methods were primarily developed for evaluation of ceramic (Specifications F603 and F1873) head designs on metal cones but may have application to other materials.

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

    1.4 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.

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

    Other Documents

    DIN 4768 Determination of Surface Roughness Ra, R z, and Rmax with Electric Stylus Instruments; Basic Data Available from Beuth Verlag GmbH (DIN--DIN Deutsches Institut fur Normung e.V.), Burggrafenstrasse 6, 10787, Berlin, Germany.

    FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems (draft Jan. 10, 1995) Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857.

    ASTM Standards

    E4 Practices for Force Verification of Testing Machines

    F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application

    F1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications

    F1875 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

    ICS Code

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

    UNSPSC Code

    UNSPSC Code 42321700(Hip joint implants)

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

    DOI: 10.1520/F2345-03R13

    Citation Format

    ASTM F2345-03(2013), Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads, ASTM International, West Conshohocken, PA, 2013,

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