ISO/DIS 23089-1

Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 1: Thoracolumbar pedicle screw systems

Scope

This document provides requirements for the pre-clinical mechanical assessment and fretting corrosion
assessment of the safety and effectiveness of Pedicle Screws Systems used in spinal arthrodesis
surgical procedures.
This document focuses on the mechanical requirements and associated fretting corrosion.
This document does not intend to cover all the requirements related to this specific kind of implants.
However, it does provide a minimum data set which shall be considered for the development of a safe
and effective spinal implant regarding its complex mechanical loading scenario.
This document does not cover semi-rigid, dynamic pedicle screw systems and surface coated pedicle
screws.