BS EN ISO 16061-2009 与非有源外科植入物共同使用的器械.一般要求

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【英文标准名称】:Instrumentationforuseinassociationwithnon-activesurgicalimplants-Generalrequirements
【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】:BSENISO16061-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-12-31
【实施或试行日期】:2009-12-31
【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】:轴承;生物危害;检验;临床的;组分;连接件;结构细节;损伤;定义;设计;评定;一般条件;植入物(外科);钝性的;使用说明书;仪器;处理;材料;测量;测量技术;医疗器械;医疗设备;医疗产品;医学科学;包装件;生产;保护(装置);选择;规范(验收);消毒;灭菌;外科学;外科设备;外科植入物;外科器械;试验;运输
【英文主题词】:Bearings;Biologicalhazards;Checks;Clinical;Composition;Connections;Constructiondetails;Damage;Definitions;Design;Evaluations;Generalconditions;Implants(surgical);Inactive;Instructionsforuse;Instruments;Marking;Materials;Measurement;Measuringtechniques;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Packages;Production;Protection;Selection;Specification(approval);Sterile;Sterilization(hygiene);Surgery;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Transport
【摘要】:ThisInternationalStandardspecifiesgeneralrequirementsforinstrumentstobeusedinassociationwithnonactivesurgicalimplants.Theserequirementsapplytoinstrumentswhentheyaremanufacturedandwhentheyareresuppliedafterrefurbishment.ThisInternationalStandardalsoappliestoinstrumentswhichmaybeconnectedtopower-drivensystems,butdoesnotapplytothepower-drivensystemsthemselves.Withregardtosafety,thisInternationalStandardgivesrequirementsforintendedperformance,designattributes,selectionofmaterials,designevaluation,manufacture,sterilization,packagingandinformationtobesuppliedbythemanufacturer.ThisInternationalStandardisnotapplicabletoinstrumentsassociatedwithdentalimplants,transendodonticandtransradicularimplantsandophthalmicimplants.
【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