ISO - DIS 23089-2
Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices
|Publication Date:||2 October 2020|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This document provides requirements for the mechanical assessment of spinal IBFDs used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments that may be necessary for various types of IBFDs. Additional assessments may be necessary to assess technical aspects of the device not completely covered by the assessments outlined in this document such as, but not limited to, coating characterization, impact testing, expulsion testing, and additive manufacturing process validations.