ASTM F382 PDF
ASTM F Flexural Fatigue Testing Metallic Bone Plates. After orthopedic reconstructive ASTM F Metallic Angled Orthopaedic Fracture Fixation Devices. Although ASTM F (Four Point Bend) test standard may seem very straight forward, there are specific guidelines you must follow to maintain. Metallic Bone Plates need to undergo several tests before gaining approval as internal fixation devices of the skeletal system. One standard, ASTM F
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The four point flexural bend fixture consists of two loading rollers near the center and two support rollers at the ends of the fixture. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use. There are instances when we test prototypes and new devices without an established test specification. Abnormally shaped bone plates will obviously be much trickier to set up and test.
Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested. There are many steps a Test Engineer or Technician can take early in the testing stages to avoid the painful woes of mechanical testing. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.
ASTM F382 Flexural Fatigue Bone Plate Fixation Devices Test Equipment
TestResources has advanced experience in the biomedical field. This specification and test method establishes the consistent methods for classifying, and defining the geometric and performance characteristics of five types cloverleaf, cobra head, reconstruction, straight, and tubular of metallic bone plates used in the surgical internal fixation of the skeletal system.
The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Static and fatigue forces up to 50 kN 11, lbf Frequency ratings up to 75 Hz Oil-free, all electric actuator for clean test conditions Lower purchase, operating, and maintenance costs than hydraulic equivalents.
Active view current version of standard. Some specimens are unusual in shape, size and function.
There are occasions when the test must deviate from the spec in ast to successfully carry out the experiment. The concave surface of the bone plate which will come into contact with the bone during surgery should face upward in testing, toward the load rollers. Rollers are available in various sizes for different size bone plates.
Important Guidelines for ASTM F382 Bone Plate Testing
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. When working with the FDA or another regulatory body, one will have to justify their reason for deviating from a specification.
Give one of our application engineers a call today for help with creating the best budget and testing plan according to ASTM F Your test setup will undoubtedly have an impact on your mechanical testing results. Rigid extension segments work well to sufficiently lengthen small bone plates so that they can be tested per the four point bend method. For ASTM F testing, the orientation of the bone plate will have a direct effect on the strength of the part in a four point bend scenario.
More content from this author Learn about our Engaged Experts. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs.
ASTM F Flexural Fatigue Bone Plate Fixation Devices Test Equipment
The user should follow the standard as closely as possible when dealing with irregular geometries and ASTM F ff382 guidelines for this case.
As Mechanical Testing Engineers we can provide valuable insight into when to deviate from a test specification and when not to. In most instances, only a subset of the herein described test methods will be required. Alternatively, the test method may be used to estimate a bone plate’s fatigue strength for a specified number of fatigue cycles.
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F suggests using rollers of equal diameters within the range of 6 to 12 mm. Therefore, the method is not applicable for satm bone plates made from materials that exhibit non-linear elastic behavior.
Know when to deviate, and when not to. This neither defines the levels of performance or case-specific clinical performance for bone plates, nor describes specific designs for bone plates. In most instances, only a subset of the herein described test methods will be required. Link to Active This link will always route to the current Active version of the standard. For testing bone platesuse your best judgment — but also consult with the plate designer and any regulatory officials.
The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates.