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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ASTM F – 17 Standard Specification and Test Method for Metallic Bone Plates
Although the ASTM F Four Point Bend test standard may seem very straight forward, there are specific guidelines the user must follow in order to maintain test validity. This article is geared towards bone plate testing within the medical device industry. There are many steps a Test Engineer or Technician can take early in the ast, stages to avoid the painful woes of mechanical testing.
Three general items come to mind when performing any mechanical test. Become familiar with the test standard in aatm to perform the test accurately.
The user should be aware of items that will influence the outcome aztm a test. Your test setup will undoubtedly have an impact on your mechanical testing results. 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. The concave surface of the bone plate which will come into contact with the bone f3882 surgery should face upward in testing, toward the load rollers. The convex surface, where accompanying bone screws will be inserted, should face downward, towards the support rollers.
Abnormally shaped bone plates will obviously be much trickier to set up and test.
The user should follow the standard as closely as possible when dealing with irregular geometries and ASTM F provides guidelines for this case. For testing bone platesuse your best judgment — but also consult with the plate designer and any regulatory officials.
Plate bending ASTM F
Roller dimensions are another important factor. F suggests using rollers of equal diameters within the range of 6 to 12 mm. While on the subject of test setup, we should also discuss the use of rigid extension segments. Rigid extension segments work well to sufficiently lengthen small bone plates so that they can be tested per the four point bend method.
As Mechanical Testing Engineers we can provide valuable insight into when to deviate from a test specification and when not to. There are occasions when the test must deviate from the spec in order to successfully carry out the experiment.
Some specimens are unusual in shape, size and function. There are instances when we test prototypes and new devices f3822 an established test specification.
Either way, there are appropriate occasions when the user may deviate from a test standard. When working with the FDA or another regulatory body, one will have to justify their reason for deviating from a specification.
If the test data is for internal use, then one can deviate more loosely. When comparing test results of prototype devices and predicate devices, make sure the tests were conducted in a similar fashion, without major deviations or asm in test setup, the specimen, and method in which data was collected and analyzed.
Important Guidelines for ASTM F382 Bone Plate Testing
View more articles about More Sectors. By Engaged Expert Maciej Jakucki. More content from this author Learn about our Engaged Experts. Perfect f3382 test setup. Know when to deviate, and when not to. View more articles about More Sectors Find related articles to you through the Nucleus. Make an inquiry today.