YY 0117.3-2005外科植入物 骨关节假体锻、铸件 钴铬钼合金铸件.pdf

ICS 11.040.40 C 35 YY 中华 人 民共和 国医药 行 业标 准 YY 0117.3-2005 代替 YY 0117.3-1993 外科植入物 骨关节假体锻、铸件 钻铬钥合金铸件 Implantsforsurgery-Forgings,castingsforbonejointprostheses- Cobaltchromiummolybdenum alloycastings 2005-12-07发布 2006-12-01实施 国家食品药品监督管理局 发 布 YY 0117.3- 2005 目 次 月U舀 ··················································································································…… 皿 1 范 围 ···············································································································…… 1 2 规范性引用文件 ··········································.···…… 1 3 要求 ···············································································································…… 1 4 试验方法 ····················…… 八··········································································…… 2 5 检验规则 ········································，····························································…… 2 6 质量证明 ·········································································································…… 3 7 标志、包装、运输、贮存 ··························································································……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 … 5 YY 0117.3- 2005 nil 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