Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Importancia y uso:

A2.5 Significance and Use

A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles.

A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in situ loading configuration. The user should note that the test results generated by this test method cannot be used to directly predict the in vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs.

A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.

A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.

A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.

Subcomité:

F04.21

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

angled devices; bend testing; blade plate; compression hip screw; fatigue test; orthopedic medical devices; surgical devices; surgical implants;