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现代材料分析技术在人体置入物检测中的应用
引用本文:刘斌.现代材料分析技术在人体置入物检测中的应用[J].中国组织工程研究与临床康复,2009,13(39).
作者姓名:刘斌
作者单位:国家食品药品监理局医疗器术审评中心,北京市,100810
摘    要:目的:结合现代分析技术领域中的一些最新研究动态,简要概述了置入材料组分分析和性能检测的一些主要方法及其应用实例.资料来源:英文资料的检索时间范围为1987/2009,检索关键词为"implantation,analytical method,testing";中文资料的检索时间范围为1997/2009,检索关键词为"置入材料,分析技术,检测".检索数据库:Medline(http://www.isiknowledge.com/MEDLINE),万方数据库(http://www.wanfangdata.com.cn).检索文献包括研究原著、综述、述评、经验交流、病例报告和荟萃分析等.总计检索75篇.资料选择:纳入近年发表的针对性强的文献,同一领域的文献则选择近期发表或权威的杂志的文章.排除与置入材料的分析表征方法、应用无关,以及内容重复和陈旧的文献.结局评价指标:初检得到75篇文献,包括中文29篇,英文46篇.阅读标题和摘要进行初筛,排除研究目的与本课题无关的30篇,内容重复的研究15篇,保留30篇中英文文献进一步分析,其中综述、述评6篇,研究论文24篇.结果:随着医疗技术的发展,临床上对置入材料的需求越来越大,人体置入材料的检测越来越多地引起关注. 将现代材料分析表征技术应用到人体置入物的检测中,通过对材料的组成、结构和性能的剖析,探讨结构与性能的关系以及在制备、加工与应用过程中材料性能的变化规律,不仅是材料表征的重要组成部分,而且将对规范人体置入物产品,以及判定不良事件等都起到重要的作用.结论:现代分析技术在置入材料的检测以及置入产品的失效分析中都起到了重要作用.

关 键 词:置入物  分析方法  性能  检测

Application of modern analytical technology on testing implants
Liu Bin.Application of modern analytical technology on testing implants[J].Journal of Clinical Rehabilitative Tissue Engineering Research,2009,13(39).
Authors:Liu Bin
Abstract:OBJECTIVE: Based on the point of introducing novel analytical methods into the testing of implanted materials, this article will summarize the principle and development of those effective analysis technologies, and the applications in testing and evaluation of medical implantations.DATA SOURCE: We retrieved Medline database (http://www.isiknowledge.com/MEDLINE) from 1987 to 2009 and Wanfang database (http://www.wanfangdata.com.cn) from 1997 to 2009, with the key words of "implantation, analytical method, testing". A total of 75 literatures of original articles, review, commentary, exchange of experience, case report and meta-analysis were retrieved.DATA SELECTION: The literatures published in recent years with strong directions were included, and those in the same field published recently or in authoritative journals were used. The literatures of analytical syndrome method and application of implant material, or with repetitive and old contents, were excluded.MAIN OUTCOME MEASURES: Totally 75 literatures, including 29 Chinese articles and 46 English articles, were included.Following reading titles and abstracts, 30 articles of unrelated research objective, and 15 articles of repetitive content were excluded. Finally 30 articles were used, composing 6 reviews and commentaries and 24 original articles.RESULTS: The requirement of implantations are growing with the development of clinic technology, along with much more attentions have been paid on the testing and evaluation of implanted materials and products. Modern analytical technology should be introduced into testing of implanting materials, which could not only clarify the relations between structure and performance, but also standard the testing method and judge the failures in medical accident.CONCLUSION: Modern analytical technology plays an essential effect on detecting implantation materials and on failureanalysis of implantation products.
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