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.pdf

标准号：ISO 18192-1-2008
实施状态：作废
中文名称：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
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：2008-01
被替代标准：ISO 18192-1-2011
代替标准：ISO/FDIS 18192-1-2007
采用标准：BS ISO 18192-1-2009,IDT
起草单位：ISO/TC 150
标准简介：This part of ISO 18192 defines a test procedure for the relative angular movement between articulating
components, and specifies the pattern of the applied force, speed and duration of testing, sample
configuration and test environment to be used for the wear testing of total intervertebral spinal disc
prostheses.
Both lumbar and cervical prostheses are addressed. This part of ISO 18192 does not address partial disc
replacements, such as nucleus replacements or facet joint replacements. The test method focuses on wear
testing. 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 obtained
with this test method will enable comparison between different types of implants but can differ from the clinical
wear performance. The user of this part of ISO 18192 should consider running additional wear tests
addressing specific safety issues of the individual implant design to be tested.
文件格式：PDF
文件大小：581.54KB
文件页数：30
（以上信息更新时间为：2019-11-22）



文档语言及版本参照下方封面截图：