Test Methods For Intervertebral Body Fusion Devices
|Publication Date:||1 June 2018|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
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.
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.
The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies.
These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).
Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies.
Some intervertebral body fusion device assemblies may not be testable in all test configurations.
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.
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.
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.