YY0017-2002骨接合植入物金属接骨板.pdf

《YY0017-2002骨接合植入物金属接骨板.pdf》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、ics11.040.40C35yy中华人民共和国医药行业标准YY0017-2002代替YY0017-1990,YY0121-1993骨接合植入物金属接骨板Implantsforosteosynthesis-Metallicboneplates2002一09一24发布2003一04一01实施国家药品监督管理局发布YY0017-2002目次前言························································································

2、··························⋯⋯11范围··············································································································⋯⋯12规范性引用文件·················。······························································。，·············⋯⋯13分类与命名··

3、···。。·······························································。································。⋯14要求·······································································································。·，··⋯⋯115试验方法···································

4、··································，··································⋯⋯126检验规则··········································。·······。······················································⋯⋯127使用说明书··········。··，····················································

5、················。。··················⋯⋯128标志·····4·‘········································································，·····“···，·············⋯⋯129包装。··················。··。。·················································································

6、······⋯⋯1210运输和贮存·································································································⋯⋯1211使用要求··················································。··················································⋯⋯12YY0017-2002NUJ吕本标准按照YY0341-200

7、2《骨接合用非有源外科金属植人物通用技术条件》的基本要求，对YY0017-1990(金属直型接骨板》和YY0121-1993《金属异形接骨板》进行了合并、修订。本标准中的孔、槽的尺寸参照采用了ISO5836:1988(外科植入物—金属接骨螺钉—与非对称螺纹和头部表面为圆球形的螺钉相对应的孔》,ISO9269:1988(外科植人物—金属接骨板—与头部下表面为圆锥体螺钉相一致的孔和槽》。本标准自实施之日起，YY0017-1990《金属直型接骨板》和YY0121-1993《金属异形接骨板》同时废止。本标准由国家药品监督

8、管理局提出并批准。本标准由全国外科植人物和矫形器械标准化技术委员会(CSBTS/TC110)归口。本标准起草单位:上海医疗器械(集团)有限公司手术器械厂。本标准主要起草人:刘伟群。YY0017-2002骨接合植入物金属接骨板范围本标准规定了骨接合植人物—金属接骨板的分类与命名、要求、试验方法、检验规则、标志、使用说明书、包装、运输、贮存及使用要求。本标准适用于供骨科手术时