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ISO 18192-1-2008 外科植入物.全椎间盘假肢的磨损.第1部分:磨损测试用负荷和位移参数及相应的试验环境条件

ISO 18192-1-2008 外科植入物.全椎间盘假肢的磨损.第1部分:磨损测试用负荷和位移参数及相应的试验环境条件

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【英文标准名称】: Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
【原文标准名称】: 外科植入物.全椎间盘假肢的磨损.第1部分:磨损测试用负荷和位移参数及相应的试验环境条件
【标准号】: ISO 18192-1-2008
【标准状态】: 作废
【国别】: 国际
【发布日期】: 2008-01
【实施或试行日期】:
【发布单位】: 国际标准化组织(IX-ISO)
【起草单位】: ISO/TC 150
【标准类型】: ()
【标准水平】: ()
【中文主题词】: 磨蚀试验;脊椎;电容性负载;定义;材料;机械测试;医学科学;方位;矫形外科设备;外科矫形植入物;修复术;修复装置;试剂;外科学;外科植入物;试验报告;试样;测试;磨损
【英文主题词】: Abrasion tests;Backbone;Capacitive loads;Definitions;Materials;Mechanical testing;Medical sciences;Orientation;Orthopaedic equipment;Orthopaedic implants;Prosthesis;Prosthetic devices;Reagents;Surgery;Surgical implants;Test reports;Test specimens;Testing;Wear
【摘要】: This part of ISO 18192 defines a test procedure for the relative angular movement between articulatingcomponents, and specifies the pattern of the applied force, speed and duration of testing, sampleconfiguration and test environment to be used for the wear testing of total intervertebral spinal discprostheses.Both lumbar and cervical prostheses are addressed. This part of ISO 18192 does not address partial discreplacements, such as nucleus replacements or facet joint replacements. The test method focuses on weartesting. Additional mechanical tests such as fatigue testing can be required.This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear data obtainedwith this test method will enable comparison between different types of implants but can differ from the clinicalwear performance. The user of this part of ISO 18192 should consider running additional wear testsaddressing specific safety issues of the individual implant design to be tested.
【中国标准分类号】: C35
【国际标准分类号】: 11_040_40
【页数】: 25P;A4
【正文语种】: 英语

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