YY0118-2005髋关节假体.pdf

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1、ICS11.040.40C35yy中华人民共和国医药行业标准YY0118-2005代替YY0118-1993TM关节假体Hipjointprostheses2005-12-07发布2006-12-01实施国家食品药品监督管理局发布YY0118-2005目次前言····················································································，··················⋯⋯1范围···················，···········，····················

2、···························...·················.·⋯⋯2规范性引用文件······，···················，，，··················，，·················⋯⋯““““‘一”““3术语和定义、分类···············1·······11，。。·，，··，，，··················11···⋯⋯4要求·········································，·······································

3、················，⋯⋯35试验方法·········································································....⋯⋯，.···⋯⋯，..⋯56检验规则················，···········································，·······⋯⋯，........··..·····...⋯⋯67使用说明书····，····，·························，，，·············..........⋯⋯，.⋯卜卜.

4、......⋯⋯，⋯78标记················‘············································，，·······································，⋯79包装····································，························，·······································⋯⋯810运输和贮存···················································，·····

5、··，··········⋯⋯，，，...··⋯⋯，.⋯⋯8附录A(规范性附录)已认可的用于制造髓关节假体的材料标准一览表9附录B(规范性附录)已认可的和不认可的用于制造髓关节假体关节面的材料一览表··⋯10附录C(规范性附录)已认可的和不认可的髓关节假体非关节接触面的金属组合一览表··⋯11参考文献········，············...⋯⋯，，....··.·........................................⋯⋯，.........⋯⋯12YY0118-2005月U吕本标准3.2,4.3,4.4为推荐性条款。本标准主要参考了IS07

6、206-1《外科植入物--一全髓和部分髓关节假体第1部分:分类与尺寸标注》、工SO7206-2《外科植人物一全髓和部分髓关节假体—第2部分:金属、陶瓷和塑料材料关节面》,ISO14630《无源外科植人物一通用要求》,ISO21534《无源外科植人物—关节置换植人物一特殊要求》,ISO21535《无源外科植人物—关节置换植入物—髓关节置换假体的专用要求》、YY/T0340(外科植入物—基本原则》和YY0341《骨接合用非有源外科金属植人物—通用技术条件》。本标准代替YY0118-1993(髓关节假体》。本标准与YY0118-1993相比主要差异为:—第3章中“定义”，采用了国

7、际标准ISO21535《无源外科植人物—关节置换植人物—髓关节置换假体的专用要求》中的定义部分;—在技术内容上参考了国际标准、国家标准和行业标准最新版本的内容要求，对各项技术内容进行了重新编写。本标准的附录A、附录B和附录C均为规范性附录。本标准由国家食品药品监督管理局提出。本标准由全国外科植人物和矫形器械标准化技术委员会(SAC/TC110)归口。本标准起草单位:北京百慕航材高科技股份有限公司本标准主要起草人:田彬、沈思宏、乔镇。YY0118-2005髓关节假体范围本标准规定了全髓和部分靛关节假体的定义、分类、要