YY0117.3-2005外科植入物骨关节假体锻、铸件钴铬钼合金铸件.pdf

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1、ICS11.040.40C35YY中华人民共和国医药行业标准YY0117.3-2005代替YY0117.3-1993外科植入物骨关节假体锻、铸件钻铬钥合金铸件Implantsforsurgery-Forgings,castingsforbonejointprostheses-Cobaltchromiummolybdenumalloycastings2005-12-07发布2006-12-01实施国家食品药品监督管理局发布YY0117.3-2005目次月U舀········································

2、··········································································⋯⋯皿1范围···············································································································⋯⋯12规范性引用文件··········································.·........................

3、......·....·..........⋯⋯13要求···············································································································⋯⋯14试验方法····················⋯⋯八··········································································⋯⋯25检验规则··················

4、······················，····························································⋯⋯26质量证明·········································································································⋯⋯37标志、包装、运输、贮存···························································

5、·······························⋯⋯4附录A(规范性附录)关于外科植人物—骨关节假体钻铬钥合金铸件缺陷补焊的专项要求⋯5YY0117.3-2005nil舌YY0117的总标题为《外科植人物骨关节假体锻、铸件》，由下列几部分组成:—第1部分:Ti6A14V钦合金锻件;—第2部分:ZTi6A14V钦合金铸件;—第3部分:钻铬钥合金铸件。本部分在原YY0117.3-1993(外科植人物骨关节假体锻、铸件钻铬铝合金铸件)}行业标准基础上进行修订。本部分对YY0117.3-1993所做的修改包括:—删除“锻件分类”

6、章节;—材料的化学成分和力学性能的要求及其实验方法执行新版的国际标准和国家标准;—检验规则更加细化;—对某些章节的编排做了相应调整。本部分主要根据国际标准ISO5832-4;1996(外科植人物—金属材料—第4部分:铸造钻铬铝合金》进行修订，在化学成分、力学性能、技术指标上等同该国际标准。本部分附录A为规范性附录。本部分代替YY0117.3-1993《外科植人物骨关节假体锻、铸件钻铬钥合金铸件》。本部分由国家食品药品监督管理局提出。本部分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。本部分起草单位:北京百慕航材

7、高科技股份有限公司。本部分主要起草人:周学玉、刘忠良、江霞、丁致平YY0117.3-2005外科植入物骨关节假体锻、铸件钻铬钥合金铸件范围本部分规定了外科植人物用钻一铬一铝合金材料制造外科植人物骨关节假体铸件的要求、试验方法、检验规则、质量证明、标志和包装等。本部分适用于骨关节假体钻铬钥合金铸件的生产和验收。2规范性引用文件下列文件中的条款通过本部分的引用而成为本部分的条款。凡是注明日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适于本部分，然而，鼓励根据本部分达成协议的各方研究是否可使用这些文件的最新版本。凡是不注

8、明日期的引用文件，其最新版本适用于本部分。GB/T223钢铁及合金化学分析方法GB/T228金属材料室温拉伸试验方法(GB/T228-2002,egvISO6892;1998)GB17100外科植人物用铸造钻铬铝合金(G