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ASTM F2624-12(2016)

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

1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.

1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).

1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.

1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.

1.5 This test method is not intended to address facet arthroplasty devices.

1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting.

1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner.


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