Standard Specification and Test Method for Metallic Bone Plates

Importancia y uso:

A2.5 Significance and Use

A2.5.1 This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. 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. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.

A2.5.2 This test method utilizes a simplified bone plate 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 bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate 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 bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit nonlinear elastic behavior.

A2.5.5 This test method is restricted to the testing of bone plates within the linear-elastic range of the material. 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.

Subcomité:

F04.21

Referida por:

F0897-19, F0564-17, F0384-24, F3437-23, F2502-24, F2193-20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

bend testing—surgical implants; bone plate; fatigue test; orthopedic medical devices—bone plates; surgical devices; test methods—surgical implants;