ISO/CD 23089-1

A draft is being reviewed by the committee.

Abstract

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.