1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.
1.3 The test method describes static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.
1.4 This test method does not purport to address expulsion testing of intervertebral body fusion device assemblies. However, since expulsion is a potential clinical failure mode, the user should address the implant's resistance to expulsion.
1.5 Guidelines are established for measuring displacements, determining the yield load or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
1.6 Some intervertebral body fusion device assemblies 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.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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