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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Bending strength and stiffness information and fatigue life of the device are determined in this specification.

ASTM F – 99 Standard Specification and Test Method for Metallic Bone Plates

However, it must be noted that the user is not obligated to test using all of the described methods. Rigid extension segments work well to sufficiently lengthen small bone plates so that they can be tested per the four point bend method. Abnormally shaped bone plates will obviously be much trickier to set up and test. Historical Version s – view previous versions of standard.

This test method may be used to determine a fatigue life of the bone plate f82 either a specific maximum bending moment or over qstm range of maximum bending moment conditions.

The user is cautioned to consider the appropriateness of the method in view of the devices being tested and astj potential application. No other units of asgm are included in this standard.

Either way, there are appropriate occasions when the user may deviate from a test standard. Alternatively, the test method may be used to estimate a bone plate’s fatigue strength for a specified number of fatigue cycles. While on the subject of test setup, we should also discuss the use of rigid extension segments.

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More content from this author Learn about our Engaged Experts. 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.

ASTM F382 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 provides guidelines for this case.

The concave surface of the bone plate which will come into contact with the bone during surgery should zstm upward in testing, toward the load rollers. For ASTM F testing, the orientation wstm the bone plate will have a direct effect on the strength of the part in a four point bend scenario. 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.

Important Guidelines for ASTM F382 Bone Plate Testing

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.

There are occasions when the test must deviate from the spec in order to successfully carry out the experiment. When comparing test results of prototype devices and predicate devices, make sure ashm 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 d382.

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 asmt the skeletal system.

Have a question about conducting the test for this standard? The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.

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The user should be aware of f32 that will influence the outcome of a test. 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.

Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior. ASTM F covers testing methods for mechanical properties of metallic bone plates. The four point flexural bend fixture consists of f3882 loading rollers near the center and two support rollers at the ends of the fixture.

When working with the FDA or another regulatory body, one will have to justify their reason for deviating from a specification. The convex surface, where accompanying bone screws will be inserted, should face downward, towards the support rollers. 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. In most instances, only a subset of the herein described test methods will be required.

There are instances when we test prototypes and new devices without an established test specification.

ASTM F Flexural Fatigue Bone Plate Fixation Devices Test Equipment

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. View more articles about More Sectors. If the test data is for internal use, then one can deviate more loosely.