标准编号：ISO 18192-1:2011
中文名称：外科植入物 整个脊椎间盘假体的磨损 第1部分：磨损试验用负荷和位移参数以及相应的试验环境条件
英文名称：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
发布日期：2011-03
标准范围
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 for use for the wear testing of total intervertebral spinal disc prostheses.Both lumbar and cervical prostheses are addressed. This part of ISO 18192 is not applicabe to 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 enables comparison between different types of implants, but can differ from the clinicalwear performance. The user of this part of ISO 18192 can consider running additional wear tests addressingspecific safety issues of the individual implant design under test.
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