ISO 16436-1

Implants for surgery — Wear of total shoulder-joint prostheses — Part 1: Methodology for simulator wear testing of anatomic total shoulder-joint prostheses

Apstrakt

This document describes a wear testing method of anatomic total shoulder-joint prostheses that specifies relative motion between the implant components and the pattern of the applied forces. This document includes the basic configuration of the simulator, sample number and alignment, test environment, speed and duration of testing, verification of inputs, measurement of kinematics and other details of the procedure and reporting.
The primary outcome is the evaluation of wear performance of total anatomic shoulder-joint prostheses, which includes both qualitative and quantitative methods. The qualitative methods of wear evaluation are included in this document and the methods of quantitative wear measurement are covered in ISO 14243-2.