IDENTIFICATION OF THE PARAMETERS THAT INFLUENCE THE UNCERTAINTY SOURCES IN ORTOPHAEDIC IMPLANTS FATIGUE TESTS

Renato Reis Machado, Cláudio Afonso Koch, Rafael Soares de Oliveira, Ana Rosa Martins, Carlos Rodrigo Roesler, Ieda Caminha

Abstract

Orthopaedic implants should be designed and manufactured in such a way to protect the patient and user against imperfections and damages. These medical devices require specific tests to evaluate their performance like: tensile strength, resistance to wear and fatigue, among others. These tests represent a way to ensure that the implants are both reasonably safe and effective for their intended use. Due to design requirements dictated by the anatomy, and physiology of the skeletal structure of the human body, these devices present complex geometric forms and so fatigue tests often involve applying complex load profiles under multi-axial conditions using specialized test fixtures. In this context, the uncertainty evaluation of the fatigue test assumes a relevant role to ensuring that the mechanical qualification of the orthopedic implant is been performed in agreement with the metrological requirements. This study presents an inter-institutional working plan to evaluate the testing machine performance and the uncertainty associated with fatigue tests of orthopaedic implants, including the identification and quantification of uncertainty sources and the first steps leading to the development of a methodology for dynamic force calibration.

Keywords

dynamic force calibration, fatigue tests, orthopaedic implants, uncertainty evaluation

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IMEKO-WC-2009-TC3-425.pdf

DOI

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IMEKO TC

TC3 - Measurement of Force, Mass, Torque, and Gravity

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