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1、】〔511.040.30C35中华人民共和国医药行业标准YY1122-2005代替YY91122-1999,YY91134-1999咬骨钳(剪)通用技术条件Generaltechniquerequirementsfororthopaedicsclamp(scissor)2005-12-07发布2006-12-01实施国家食品药品监督管理局发布YY1122-2005目次前言······，，·········..........................................................
2、..................···················⋯⋯m1范围······。································，，，···············，·······“·······，·······················，········⋯⋯12规范性引用文件···············，·············，·，······························，···········，·········⋯⋯‘·····⋯⋯13型式和基本尺
3、寸、材料·························，·························································，······⋯⋯14要求····，···········，··4··················，，，·4·11···，，-··4·，，，，·····1····，，·......'........................··⋯Y5试验方法·二···】·········，·····。·······，····，···········，，·
4、，，·············甲，，，，，，····，······，，··，、·····⋯⋯26检验规则··。···································，································································⋯⋯27标志、使用说明书····，·········，·········，·······················，·，······················，，······，······“····⋯⋯
5、38包装、运轴、贮存···········，··································，·····································，·······⋯⋯3YY1122-2005月U言本标准参照德国国家标准，将咬骨钳、剪合并制定为一份标准。本标准代替YY91122-1999《侧角头双关节咬骨钳》和YY91134-1999《双关节骨剪》。本标准与YY91122-1999,YY91134-1999的主要差异如下:—增加了耐腐蚀性能要求;—扩大了制造咬骨钳(剪)的选材范围
6、;—修订了抽样方法;—取消了咬骨钳(剪)外表面电镀的要求。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术委员会(SAC/TC110)归口。本标准由上海医疗器械(集团)有限公司手术器械厂负责起草。本标准主要起草人:刘伟群。本标准所代替标准的历次版本发布情况为:-YY91122-1999,WS2-54-1974;—YY91134-1999,WS2-182-1974YY1122-2005咬骨钳(剪)通用技术条件范围本标准规定了咬骨钳(剪)的型式和基本尺寸、材料、要求、试验方法、检验规则、标志、
7、使用说明书、包装、运输和贮存。本标准适用于单关节或双关节咬骨钳(剪)，以下简称骨钳(剪)。2规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准.GB/T230.1-2004金属洛氏硬度试验第1部分:试验方法(A,B,C,D,E,F,G,H,K,N,T标尺)(ISO6508.1:1999,MOD)GB/T12
8、20-1992不锈钢棒(neqJISG4303;1988)GB/T1315厚纸板GB/T1910新闻纸GB/T2828.1-2003计数抽样检验程序第1部分:按接收质量限(AQL)检索的逐批检验抽样计划(ISO2859.1c1999,IDT)GB/T2829周期检查计数抽样程序及表(适用于过程稳定性的检验)YY/T0149-199
