ASTM WK52025

    New Specification for Metallic Bone Plates Used in Small Bone Fracture Fixation

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    Developed by Subcommittee: F04.21 | Committee F04 | Contact Staff Manager



    WK52025

    1. Scope

    1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load bearing anatomical areas of the far extremities, such as the fingers and toes, and in the cranium and upper face. Lower face/mandible, wrist, and ankle fixation plates would generally be larger and carry a substantial amount of load and should not be evaluated under this standard. 1.2 Test standards ASTM F382 and ISO 9585 are currently available for the testing of metallic bone plates. However, due to plate size, the difficulty in set-up and execution of ASTM F382 and ISO 9585 tests for small bone plates can be increased. Thus, this standard offers alternative test methods that are more appropriate for metallic bone plates used in small bone fracture fixation. It must be noted that since ASTM F382 and ISO 9585 are active bone plate standards, the user can choose to use any of the tests in these standards for small bone plates as well. 1.3 This standard is not intended to address the mechanical performance of screws used in small bone plates. 1.4 This standard is intended to provide a basis for the mechanical comparison of experimental and reference small bone plates. Due to the complex and varying biomechanics found in the areas of the body where these plates are used, this standard should only be used to compare the in vitro mechanical performance of small bone plates and not used to infer in vivo performance characteristics. 1.5 This standard describes static tests by specifying load types and specific methods of applying these loads. Tests for evaluating and characterizing these loads include the following: static torsion, static cantilever beam bending, static lateral bending, and static three-point bending. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 Multiple tests are cited in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. 1.8 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.


    Keywords

    Bone plate, small bone fracture fixation, extremities, fingers, toes, digits, jaw, midface, upper face, cranium, upper face, lower face, mandible, static testing.

    Rationale

    Because of the smaller size of plates used in small bone fracture fixation, this test method is intended to offer test methods that are more appropriate for small bone plates.

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    11-02-2015

    Technical Contact:
    Joseph Turner

    Item:
    001

    Ballot:
    F04 (21-04)

    Status:
    Ballot Item Approved

    Item:
    010

    Ballot:
    F04 (20-12)

    Status:
    Negative Votes Need Resolution