BS EN ISO 16061-2008 与非有源外科植入物共同使用的器械.一般要
【英文标准名称】: Instrumentation for use in association with non-active surgical implants - General requirements 【原文标准名称】: 与非有源外科植入物共同使用的器械.一般要求 【标准号】: BS EN ISO 16061-2008 【标准状态】: 作废 【国别】: 英国 【发布日期】: 2009-05-31 【实施或试行日期】: 2009-05-31【发布单位】: 英国标准学会(GB-BSI)【起草单位】: BSI【标准类型】: ()【标准水平】: ()【中文主题词】: 检验;组分;结构细节;定义;设计;一般条件;植入物(外科);钝性的;作标记;材料;医疗设备;医学科学;包装件;生产;规范(验收);灭菌;外科学;外科设备;外科植入物;外科器械;试验【英文主题词】: Checks;Composition;Construction details;Definitions;Design;General conditions;Implants (surgical);Inactive;Marking;Materials;Medical equipment;Medical sciences;Packages;Production;Specification (approval);Sterilization (hygiene);Surgery;Surgical equipment;Surgical implants;Surgical instruments;Testing【摘要】: This International Standard specifies general requirements for instruments to be used in association with nonactivesurgical implants. These requirements apply to instruments when they are manufactured and when theyare resupplied after refurbishment.This International Standard also applies to instruments which may be connected to power-driven systems, butdoes not apply to the power-driven systems themselves.With regard to safety, this International Standard gives requirements for intended performance, designattributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information tobe supplied by the manufacturer.This International Standard is not applicable to instruments associated with dental implants, transendodonticand transradicular implants and ophthalmic implants.【中国标准分类号】: C35【国际标准分类号】: 11_040_40;11_040_99【页数】: 28P.;A4【正文语种】: 英语您好，请问您有ISO 16061-2008 这个标准么？您这上面没有提供下载，我是新手，请问可以发份给我吗？感激不尽！ 947877177@qq.com 楼主需要资料啊，我需要看看
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