ISO/TC 150/SC 5/WG 2 - Spinal devices

This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.

ISO 18192-3:2017 defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.

ISO 12189:2008 specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. It is intended to provide a basis for the assessment of intrinsic static and dynamic strength of spinal implants.