Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

Importancia y uso:

4.1 This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37 °C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.

4.2 This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs See Fig. 2, Fig. 4, and Fig. 5. See also Table 1.

4.3 Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.

Subcomité:

F04.25

Referida por:

F3292-25

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

cervical; dynamic test methods; extra-discal; lumbar; lumbosacral; posterior instrumentation; single level; spinal implant; static test methods; thoracic; thoracolumbar; wear; wear assessment; weight loss method;