ASTM F2346-18 PDF

1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs.

1.3 These test methods describe 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 artificial intervertebral discs.

1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or 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, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs.

1.6 Some artificial intervertebral discs 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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.