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ASTM F382 Metallic Bone Plates fatigue bending test

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ASTM F382 is an authoritative American standard that specifies the geometric and performance characteristics of metallic bone plates used in orthopedic surgeries, and defines two core mechanical test methods (static and fatigue bending tests). It is of great significance for ensuring the safety and reliability of metallic bone plates, which are widely used to align and fix bone segments in orthopedic reconstructive surgeries. 


Core Scope and Objectives

  1. Applicable Scope: It is tailored for metallic bone plates applied in the surgical internal fixation of the human skeletal system. Notably, it does not mandate the use of all its test methods; users can choose the appropriate test items based on the specific design of the bone plate. Besides, it does not set specific product design standards or predict clinical performance in individual cases, as such predictions require more personalized clinical data support.


  2. Core Objectives: It provides unified and standardized testing specifications for metallic bone plates, including requirements for materials, labeling, processing, and mechanical testing. The main goal is to accurately measure key mechanical properties such as bending stiffness, bending strength, and fatigue life of bone plates. This not only helps manufacturers optimize product materials and structural designs but also provides a reliable technical basis for regulatory agencies and testing institutions to evaluate the performance of such orthopedic devices.


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 F382 Metallic Bone Plates fatigue bending testASTM F382 Metallic Bone Plates fatigue bending test


Two Key Test Methods

The standard focuses on two core test methods, both of which rely on a four-point bending fixture. This fixture is composed of two loading rollers near the center and two supporting rollers at both ends, and rollers of different sizes can be selected according to different bone plate specifications.


Test MethodSpecific ProceduresKey Outcomes
Single Cycle Bend Test

Fix the metallic bone plate specimen on the four-point bending fixture, ensuring the long axis of the plate is perpendicular to the axis of the loading rollers. Then apply an increasing load continuously and record the load-displacement curve during the whole process until the specimen deforms and bends.


Calculate the bending stiffness, bending structural stiffness, and bending strength of the bone plate. These data can reflect the bone plate’s ability to resist bending deformation under static loads during clinical bone fixation.
Bending Fatigue TestFirst, determine the applicable load level. Then install the specimen on the fixture, making sure the load is evenly distributed at the loading points. The test is carried out at a standard frequency of 5Hz to avoid the influence of strain sensitivity on the test results. The test continues until the specimen breaks or reaches the preset cycle limit.Obtain the fatigue life of the bone plate under specific maximum bending load levels or a certain range of such levels. Meanwhile, record the maximum moment during the test, the cycle count when the test ends, as well as the failure mode and location of the specimen. These data can evaluate the durability of the bone plate under long-term cyclic bending forces in clinical applications.


The standard requires testing equipment that can perform both static and dynamic tests. Recommend UnitedTest static and dynamic bone plate testing system. In addition, the dedicated four-point bending fixture is an essential accessory, which can accurately simulate the bending movement of the bone plate in the human body and ensure the accuracy of test data.


Application Significance

In the R&D phase, this standard enables researchers to compare the performance differences between different materials and structural designs of bone plates, thus guiding the optimization of product schemes. In the mass production stage, it serves as a key quality control tool to ensure that each batch of bone plates meets the unified mechanical performance standards. For manufacturers, test data compliant with this standard is also an important basis for applying for FDA approval of their products, which is crucial for the products to enter the market smoothly and be used clinically.

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