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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 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. The user should be aware of items that will influence the outcome of a test. This website uses cookies to improve user experience. Give one of our application engineers a call today for help with creating the best budget and testing plan according to ASTM F 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.

If t382 test data is for internal use, then one can deviate more loosely. Referenced Documents purchase separately The documents f832 below are referenced within the subject standard but are not provided as part of the standard.

However, it must be noted that the user is not obligated to test using all of the described methods. Your test setup will undoubtedly have an impact on your mechanical testing results.

ASTM F382 Flexural Fatigue Bone Plate Fixation Devices Test Equipment

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. Instead, the user should only select test methods that are appropriate ashm a particular device design.

However, it must be noted that the user is not obligated to test using all of the described methods. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. Futhermore, it is f38 the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.


ASTM F – Instron

The data generated from this test method can be used to conduct relative comparisons of different bone plate designs. The user should follow the standard as closely as possible when dealing with irregular geometries and ASTM F provides guidelines for this case. Roller dimensions are another important factor. By means of our biomedical testing expertise and modular product design, we will help find the testing solution that is right for you.

This neither f3822 the levels of performance or d382 clinical performance for bone plates, nor describes specific designs for bone plates. Know when to deviate, and when not to. Some specimens are unusual in shape, size and function. The strength and astj of the plate allows the bone to heal while providing structural support. 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.

When working with t382 FDA or another regulatory body, one will have to justify their reason for deviating from a specification.

ASTM F Flexural Fatigue Bone Plate Fixation Devices Test Equipment

When comparing test results of prototype devices 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 d382.

As Mechanical Testing Engineers we can provide valuable insight into when to deviate from a test specification and when not to. Active view current version of standard. 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. Alternatively, the test method may be used to estimate a bone plate’s fatigue strength for a specified number of fatigue cycles. It is the responsibility of the user of this standard to establish appropriate safety astj health practices and determine the applicability of regulatory limitations prior to use.


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.

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 f38.

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. By using our website you consent to all cookies in accordance with our Cookie Policy. View more articles about More Sectors Find related articles to you through the Nucleus.

The astj is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. Bone plates are asym during orthopedic orthopaedic reconstructive surgery for alignment and fixation of bone segments.

No other units of measurement are included in this standard. View more articles about More Sectors. This abstract is a brief summary of the referenced standard.

In most instances, only a subset of the herein described test methods will be required.

F3882 content from this author Learn about our Engaged Experts. The convex surface, where accompanying bone screws will be inserted, should face downward, towards the support rollers.

While on the subject of test setup, we should also discuss the use of rigid extension segments. 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.