YY 0591-2005骨接合植入物 金属带锁髓内钉.pdf

ICS 11.040.40 C 35 yy 中华 人 民共 和 国医药 行 业标 准 YY 0591-2005 骨接合植入物 金属带锁髓内钉 Implantsforosteosynthesis-Metalliclockableintramedullarynail 2005-12-07发布 2006-12-01实施 国家食品药品监督管理局 发 布 YY 0591- 2005 目 次 前言 ·················································································································…… 皿 1 范围 ·····················································，·························································…… 1 2 规范性引用文件 .·…… 1 3 分类 ·······························································，·························，····················…… 1 4 要求 ···············································································，·······························…… 7 5 试验方法 ·······························，······························，··········································一· 8 6 检验规则 ················································································，························…… 8 7 使用说明书 ·······················，···················，··················.················.·…… 8 8 标志 ····································，··········································································…… 8 9 包装 ·········································································，·····································…… 9 G 1 运输和贮存 n 使用要求 … YY 0591- 2005 目11 吕 本标准是在YY0341-2002《骨接合用非有源外科金属植人物通用技术条件》基础上制定的，参考 了ISO15142-1;2003外《科植人物— 金属髓内钉系统— 第 1部分:髓内钉》,ISO15142-2;2003《外 科植人物— 金属髓内钉系统— 第2部分:锁定部件》国际标准。 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