ASTM F1264 Intramedullary Fixation Device Torsion & Bend Fatigue Test

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ASTM F1264 is a standard specification used to describe the design and mechanical function of intramedullary fixation devices (IMFDs). This specification covers IMFDs used for surgical fixation of the skeletal system. In addition to classification, terminology, labeling, and material specifications, it also includes four standard testing methods:

1, static four point bending test method (Annex A1),

2, static torsion test method (Annex A2),

3, bending fatigue test method (Annex A3),

4, bending fatigue test method for IMFD locking screws (Annex A4).

The UTDS series Dynamic/Fatigue Testing machine used for bone needle, bending intramedullary nail fatigue test is mainly used for biomechanical performance testing of various materials, including artificial blood vessels, soft tissues, bones, bone plates, and vertebrae Interfusion device, knee joint, spine Dynamic and static mechanical tests on materials such as column fixators, metal coatings, hip joints, and intramedullary nails, including tension, compression, bending, and torsion.

ASTM F1264 Intramedullary Fixation Device Torsion

Core Scope and Objectives

Applicable Scope: It applies to intramedullary fixation devices designed for surgical fixation of the human skeletal system. These devices are inserted into the medullary cavity of bones and fixed with locking screws to treat fractures. Notably, users do not need to apply all the test methods in the standard; instead, they can select appropriate tests based on the specific design of the device.
Core Objectives: The standard aims to characterize the design and mechanical functions of IMFDs. It provides unified test methods to measure key properties like bending strength, torsional stiffness, and fatigue resistance. This helps manufacturers optimize product designs, assists quality inspection agencies in conducting standardized evaluations, and offers a reliable basis for regulatory authorities to review the safety of orthopedic devices. It should be emphasized that it does not specify device performance levels or predict clinical outcomes in individual patients, as such predictions require more personalized clinical data.

Four Key Test Methods

The standard includes four core test methods in its annexes, each targeting different mechanical performance aspects of IMFDs:

Test Method	Specific Procedures	Key Calculations/Outcomes
Static Four-Point Bending Test	Place the prepared IMFD specimen on a four-point bending fixture. Apply a compressive load at a constant displacement rate and record the load-displacement curve throughout the process.	Calculate the bending strength and bending structural stiffness of the device, which reflect its ability to resist bending deformation under static loads during fracture fixation.
Static Torsion Test	Secure the straight and uniform section of a specified-length IMFD specimen in a torsion testing system. Apply a pure torsional moment to the specimen and record the resulting angular deflection as well as the torque-rotation curve.	Compute the torsional stiffness, evaluating the device’s resistance to twisting forces—critical for scenarios where the implanted area is subject to rotational stress (e.g., during limb movement).
Bending Fatigue Test for IMFDs	Mount the IMFD specimen on the four-point bending fixture of a fatigue testing system. Conduct a sinusoidal cyclic loading test at a specified frequency. The test stops when the specimen fails, reaches a set limit, or completes a predetermined number of cycles.	Determine the fatigue strength and fatigue life of the main IMFD body, assessing its durability under repeated bending forces during long-term use.
Bending Fatigue Test for IMFD Locking Screws	Fix the locking screw specimen on a three-point or four-point bending fixture. Perform a sinusoidal cyclic test at the specified frequency until the screw fails or the test meets the preset termination conditions.	Calculate the fatigue strength and fatigue life of the locking screws. As a key component for securing the IMFD to bones, the fatigue resistance of these screws is vital to prevent implant loosening.

Recommended Equipment

To meet the test requirements, specific professional equipment is required, mainly including an UnitedTest universal testing machine (for static four-point bending and static torsion tests) and a UnitedTest dynamic fatigue testing machine (for the two fatigue tests). Matching fixtures are also essential, such as four-point bending fixtures for bending tests, torsion grips for torsion tests, and three-point bending fixtures for screw fatigue tests.

ASTM F1264 Intramedullary Fixation Device Torsion & Bend Fatigue Test details introductions:

Static Four-Point Bend Test Method—Annex A1.
This test method is intended to evaluate the bending strength or bending stiffness of the working length of the IMFD, and may not be appropriate for all situations. When the structurally critical region of the IMFD is shown to be located at the proximal or distal extremity of the IMFD, it may be necessary to evaluate the bending strength or bending stiffness of this region of the IMFD using a different test method. This is because it may not be physically possible to fit the proximal or distal extremity between the inner rollers of a four-point bend test. Structurally critical regions may be identified through such methods as hand calculations, finite element analysis, etc. Screw holes or other interlocking features are typically located at the proximal and distal extremities of an IMFD, and may result in structurally critical regions at these locations.
Static Torsion Test Method—Annex A2.
This test method covers the test procedure for determining the torsional stiffness of intramedullary fixation devices (IMFDs). The central part of the IMFD, with a straight and uniform cross-section and away from screw holes or other interlocking features, is tested in a static test.
Bending Fatigue Test Method—Annex A3.
This test method covers the test procedure for performing cyclic bending fatigue testing of intramedullary fixation devices (IMFDs). The central part of the IMFD, with a straight and uniform cross section and away from screw holes or other interlocking features, is tested in cyclic four-point bending. This method may be used to determine the fatigue life at a specified maximum bending moment or to estimate the fatigue strength for a specified number of cycles
Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.
This test method covers the test procedure for performing cyclic bending fatigue testing of locking screws used for the fixation of intramedullary fixation devices (IMFDs). The central part of the screw is tested in cyclic three-point or four-point bending. This method may be used to determine the fatigue life at a specified maximum bending moment or to estimate the fatigue strength for a specified number of cycles.

This standard is widely used in the R&D, production, and quality inspection of orthopedic devices. For manufacturers, it guides the optimization of IMFD structural designs and material selections. For testing and regulatory institutions, it provides a unified technical framework to verify whether products meet safety and reliability standards before they enter the market. By simulating the mechanical stresses IMFDs endure in the human body, the test results effectively guarantee the devices’ stability and durability in clinical applications, reducing the risk of implant failure or secondary injuries to patients.

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