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【英文标准名称】:Instrumentationforuseinassociationwithnon-activesurgicalimplants-Generalrequirements(ISO16061:2008,Correctedversion2009-03-15);GermanversionENISO16061:2009
【原文标准名称】:与非活性外科植入物联合使用的仪表装置.一般要求(ISO16061-2008,修正版本2009-03-15).德文版本ENISO16061-2009
【标准号】:DINENISO16061-2010
【标准状态】:现行
【国别】:德国
【发布日期】:2010-01
【实施或试行日期】:2010-01-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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;手术器械;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】:ThisInternationalStandardspecifiesgeneralrequirementsforinstrumentstobeusedinassociationwithnon-activesurgicalimplants.Theserequirementsapplytoinstrumentswhentheyaremanufacturedandwhentheyareresuppliedafterrefurbishment.ThisInternationalStandardalsoappliestoinstrumentswhichmaybeconnectedtopower-drivensystems,butdoesnotapplytothepower-drivensystemsthemselves.WithregardtosafetythisInternationalStandardgivesrequirementsforintendedperformance,designattributes,selectionofmaterials,designevaluation,manufacture,sterilization,packagingandinformationtobesuppliedbythemanufacturer.ThisInternationalStandardisnotapplicabletoinstrumentsassociatedwithdentalimplants,transendodonticandtransradicularimplantsandophthalmicimplants.
【中国标准分类号】:C31
【国际标准分类号】:11_040_30
【页数】:27P.;A4
【正文语种】:英语