Over deze norm
1.1 This practice provides guidance for the static and dynamic testing of Lumbar Total Facet Prostheses (FP). These implants are intended to allow motion and lend support to one or more functional spinal unit(s) through replacement of the natural facets.
1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic FP. These test methods allow comparison of devices with different methods of application to the lumbar spine. These test methods are intended to enable the user to mechanically compare devices and do not purport to provide performance standards for them.
1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads.
1.4 These test methods do not purport to address all clinically relevant failure modes for FP, some of which will be device specific. For example, these test methods do not address implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods.
1.5 Requirements are established for measuring displacements and evaluating the stiffness of FP.
1.6 Some devices may not be testable in all test configurations.
1.7 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
|Engelse titel||Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses|