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 F382 Flexural Fatigue Bone Plate Fixation Devices Test Equipment
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 d382 the surgical internal fixation of the skeletal system.
Alternatively, the test method may be used to estimate a bone plate’s fatigue strength for a specified number of fatigue cycles.
In most instances, only a subset of the herein described test methods will be required. Also presented here are catalogs of standard specifications for material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical single cycle bend and bend fatigue characteristics determined to be important to the in vivo performance of bone plates.
Rigid extension segments work well d382 sufficiently lengthen small bone plates so that they can be tested per the four point bend method.
ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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. Become familiar with the test standard in order to perform the test accurately.
ASTM F – 99 Standard Specification and Test Method for Metallic Bone Plates
There are instances when we test prototypes and new devices without an established test specification. This abstract is a brief aastm of the referenced standard. Link to Active This link will always route to the current Active version of the standard. Historical Version s – view previous versions of standard.
Three general items come to mind when performing any mechanical test. View more articles about Atm Sectors. We are confident that we have what you are looking for. By means of our biomedical testing expertise and modular product design, we will help find the testing solution that is right for you. We offer machines, apparatus, testers, tensile grips, test fixtures, clamps, holders, jigs, faces, jaws, extensometers, environmental and humidity chambers, furnaces, baths and custom solutions for unique applications.
However, it must be noted that the user is not obligated to test using all of the described methods. Active view current version of standard. 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. However, it must be noted that the user is not obligated to test using all of the described methods. The concave surface of the bone plate which will ast into contact with the bone during surgery should face upward in testing, toward the load rollers.
Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior.
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. If the test data is for internal use, then one can deviate more loosely. 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.
It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application.
ASTM F covers testing methods for mechanical properties of metallic bone plates. By Engaged Expert Maciej Jakucki. F suggests using rollers of equal diameters within the range of 6 to 12 mm.
Plate bending ASTM F
Perfect the test setup. 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.
Astk user should be aware of items that will influence the outcome of a test. The standard calls for a special TestResources test fixture GF that replicates bending movement in a single cycle test, as well as fatigue evaluation of the plate design.
Your test setup will undoubtedly have an impact on your mechanical testing results. Either way, there are appropriate occasions when the user may deviate from a test standard. This article is geared towards bone plate testing within the medical device industry.
Bending strength and stiffness asmt and fatigue life of the device are determined in this specification. There are occasions when the test must deviate from the spec in order to successfully carry out the aetm. For testing bone platesuse your best judgment — but also consult with the plate designer and any regulatory officials.
When comparing test results of prototype atm and predicate devices, make sure the tests were conducted in a similar fashion, without major deviations or differences in test setup, the specimen, and method in which data was collected and analyzed.
The user is cautioned to consider the appropriateness of c382 method in view of the devices being tested and their potential application.
When working with the FDA or another regulatory body, one will have to justify their reason for deviating from a specification. Abnormally shaped bone plates will asmt be much trickier to set up and test. 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.