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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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
In most instances, only a subset of the herein described test methods will be required. As Mechanical Testing Engineers we can provide valuable insight into when to deviate from a test specification and when not to. Know when to deviate, and when not to.
If the test data is for internal use, then one can deviate more loosely. Become familiar with the test standard in order to perform the test accurately. Although the ASTM F Four Point Bend test standard may seem very straight forward, there f328 specific guidelines the user must follow in order to maintain test validity.
ASTM F382 Flexural Fatigue Bone Plate Fixation Devices Test Equipment
This neither defines the levels of performance or case-specific clinical performance for bone plates, nor describes specific designs for bone plates. For testing bone platesuse your best judgment — but also consult with the plate designer and any regulatory officials.
The strength and stiffness of the plate allows the bone to heal while providing structural support. 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. Abnormally shaped bone plates will obviously be much trickier to set up and test. Bone plates are used during orthopedic orthopaedic reconstructive surgery for alignment and fixation of bone segments.
Important Guidelines for ASTM F382 Bone Plate Testing
The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. Rigid extension segments work well to sufficiently lengthen small bone plates so that they can be tested per the four point bend method. We are confident xstm we have what you are looking for. Your test setup will undoubtedly have an impact on your mechanical testing results. Bending strength and stiffness information and fatigue life of the ff382 are determined in this specification.
Plate bending ASTM F
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. Make an inquiry today.
This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior. Give one of our application engineers a call today for help with creating the best budget and testing plan according to ASTM F Three general items come to mind when performing any mechanical test. However, it must asfm noted aastm the user is not obligated to test using all of the described methods.
Futhermore, it is not the intention of the standard to describe or specify specific designs for 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. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal asstm of the skeletal system.
When working with the FDA or another regulatory body, one will have to justify their reason for deviating from a specification. The user should note that the test results generated by this test method can not be used to directly predict the in vivo performance of the bone plate being tested. In most instances, only a subset of the herein described test methods will be required.
Alternatively, the c382 method may be used to estimate a bone plate’s fatigue strength for a specified number of fatigue cycles. Have a question about conducting the test for this standard?
This article is geared towards bone plate testing within the medical device industry. 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.
Link to Active This link will always route to the current Active version of the standard. F suggests using rollers of equal diameters within the range of 6 to 12 mm. Rollers are available in various sizes for different size bone plates. 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.
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 many steps a Test Engineer or Technician can take early in the testing stages to avoid the painful woes of mechanical testing. Some specimens are unusual in shape, size and function. 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. By Engaged Expert Maciej Jakucki. 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.