Reinisch G, Judmann K P, Plitz W, Schörg J
Biomechanische Forschungs-Gesellschaft m.b.H., Wien.
Biomed Tech (Berl). 2001 Dec;46(12):362-5.
The continuing development of new, highly sophisticated materials for the articulating surfaces of total hip endoprostheses involves the need for testing, not only of biocompatibility and dynamic loadability, but also of tribological properties (friction, wear, lubrication). For decades, the wear resistance of these materials has been tested in wear simulators. In consequence of the currently often widely differing test methods, the technical committee (TC 150) of the ISO (International Organization for Standardization) has been concerned to develop an International Standard (ISO/FDIS 14242 1 and 2: Implants for Surgery--wear of total hip joint prostheses--on the basis of kinetic and kinematic data from gait analysis. This new standard will be the basis for ensuring the comparability of scientific data obtained from tribological testing of total hip endoprothesis. The new hip simulator, E-SIM, presented in this paper, complies with the currently published FDIS (Final Draft International Standard), and enables testing in accordance with these specifications.
用于全髋关节假体关节表面的新型高科技材料不断发展,这不仅需要测试生物相容性和动态负载能力,还需要测试摩擦学特性(摩擦、磨损、润滑)。几十年来,这些材料的耐磨性一直在磨损模拟器中进行测试。由于目前测试方法往往差异很大,国际标准化组织(ISO)的技术委员会(TC 150)一直致力于制定一项国际标准(ISO/FDIS 14242 1和2:外科植入物——全髋关节假体的磨损——基于步态分析的动力学和运动学数据)。这项新标准将成为确保从全髋关节假体摩擦学测试中获得的科学数据具有可比性的基础。本文介绍的新型髋关节模拟器E-SIM符合当前发布的FDIS(国际标准最终草案),并能够按照这些规范进行测试。