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    ASTM F1264 - 16e1

    Standard Specification and Test Methods for Intramedullary Fixation Devices

    Active Standard ASTM F1264 | Developed by Subcommittee: F04.21

    Book of Standards Volume: 13.01

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    Significance and Use

    A1.4 Significance and Use

    A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD.

    A1.4.2 This test method may not be appropriate for all types of implant applications (that is, in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.

    1. Scope

    1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.

    1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.

    1.3 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.

    1.4 This specification includes four standard test methods:

    1.4.1 Static Four-Point Bend Test Method—Annex A1 and

    1.4.2 Static Torsion Test Method—Annex A2.

    1.4.3 Bending Fatigue Test Method—Annex A3.

    1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.

    1.5 A rationale is given in Appendix X1.

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

    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

    A214/A214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes

    A450/A450M Specification for General Requirements for Carbon and Low Alloy Steel Tubes

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

    E4 Practices for Force Verification of Testing Machines

    E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System

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

    E1823 Terminology Relating to Fatigue and Fracture Testing

    F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

    F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

    F543 Specification and Test Methods for Metallic Medical Bone Screws

    F565 Practice for Care and Handling of Orthopedic Implants and Instruments

    F1611 Specification for Intramedullary Reamers

    F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

    F2809 Terminology Relating to Medical and Surgical Materials and Devices

    AMS Standard

    AMS 5050

    SAE Standard

    SAE J524 Seamless Low-Carbon Steel Tubing Annealed for Bending and Flaring

    ICS Code

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

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

    DOI: 10.1520/F1264-16E01

    Citation Format

    ASTM F1264-16e1, Standard Specification and Test Methods for Intramedullary Fixation Devices, ASTM International, West Conshohocken, PA, 2016, www.astm.org

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