YY 0118-2005髋关节假体.pdf

ICS 11.040.40 C 35 yy 中华 人 民共 和 国 医药 行 业标 准 YY 0118-2005 代替 YY0118-1993 MT 关 节 假 体 Hipjointprostheses 2005-12-07发布 2006-12-01实施 国家食品药品监督管理局 发 布 YY 0118- 2005 目 次 前言 ····················································································，··················…… 1 范围 ···················，···········，···············································...·················.·…… 2 规范性引用文件 ······，···················，，，··················，，·················…… ““““‘一”““ 3 术语和定义、分类 ···············1 ·······11，。。 ·，，··，，，··················11· ··…… 4 要求 ·········································，·······················································，…… 3 5 试验方法 ··········································································……，.···……，..… 5 6 检验规则 ················，···········································，·······……，·.·.·····...…… 6 7 使用说明书 ····，····，·························，，，·············.. ……，.…卜卜 ……，… 7 8 标记 ················‘············································，，·······································，… 7 9 包装 ····································，························，········································…… 8 10 运输和贮存 ···················································，·······，··········……，，，...··……，.…… 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)