ASTM F2694-07(2013)
活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

被代替

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标准号

ASTM F2694-07(2013)

发布

2007年

发布单位

美国材料与试验协会

替代标准

ASTM F2694-16

当前最新

ASTM F2694-16(2020)

 

 

适用范围

5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may be a unilateral or bilateral design.

5.2 Spinal Testing Apparatus:

5.2.1 Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.

5.2.2 Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.

5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.

5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads.

Note 1—This setup would require two rotational actuators and one translational actuator.

FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet Loading

Note 1—This setup would require two rotational actuators and one translational actuator
.

FIG. 2 Diagrams of Possible Test Apparatus for Allowing Simultaneous Flexion-Extension and Lateral Bending Motions with Anterior-Posterior Directed Facet Loading

5.2.5 Load and Motion:

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