Information on the most widely used ASTM standards within the materials testing industry
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
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.
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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 Method | Specific Procedures | Key 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 Test | First, 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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