ASTM F3631-24

1.1 This test method covers the materials and methods for impact testing of lumbar intervertebral body fusion devices (IBFD).

1.2 This test method is intended to provide a basis for the mechanical comparison among nonbiologic IBFD assemblies (the IBFD and associated inserter tool). This test method is intended to enable the user to compare these IBFD assemblies under impact loads to simulate the intra-operative surgical technique used to insert the IBFD.

1.3 The test method describes the impact test by specifying impact energies and specific methods for applying these energies. The tests are designed to allow for the comparative evaluation of IBFD assemblies.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.

1.5 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.

1.6 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.