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

ICS11.040.40

C35

YY

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-

Cobaltchromiummolybdenumalloycastings

2005-12-07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··················································································································……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

YY0117.3-2005

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