BS EN 12011-1998 与无源外科植入物一起使用的仪器.一般要求
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【英文标准名称】:Instrumentationtobeusedinassociationwithnon-activesurgicalimplants-Generalrequirements
【原文标准名称】:与无源外科植入物一起使用的仪器.一般要求
【标准号】:BSEN12011-1998
【标准状态】:作废
【国别】:英国
【发布日期】:1998-05-15
【实施或试行日期】:1998-05-15
【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】:化学成分;材料;铁素体钢;选择;灭菌;等级(质量);生产;沉淀硬化;手术器械;设计;外科设备;成份允差;外科植入物;奥氏体钢;不锈钢;马氏体钢;使用说明;医疗器械;性能;检验;包装
【英文主题词】:Bearings;Biologicalhazards;Checks;Clinical;Composition;Damage;Definitions;Design;Evaluations;Generalconditions;Implants(surgical);Inactive;Instructionsforuse;Instruments;Marking;Materials;Measurement;Medicalequipment;Medicalsciences;Packages;Production;Protection;Selection;Specification(approval);Sterile;Sterilization(hygiene);Surgery;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Transport
【摘要】:ThisEuropeanStandardspecifiesgeneralrequirementsforinstrumentstobeusedinassociationwithnon-activesurgicalimplants.Theserequirementsapplytoinstrumentswhentheyaremanufacturedandwhentheyarere-suppliedafterrefurbishment.Thisstandardappliestoinstrumentswhichmaybeconnectedtopowereddrivensystems,butdoesnotapplytothepowereddrivensystemitself.Thisstandardisnotapplicabletoinstrumentsassociatedwithdentalimplants,transendodonticandtransradicularimplantsandophthalmicimplants.Withregardtosafely,thisstandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,packagingandinformationsuppliedbythemanufacturer.
【中国标准分类号】:C35
【国际标准分类号】:11_040_30
【页数】:14P;A4
【正文语种】:英语
【原文标准名称】:与无源外科植入物一起使用的仪器.一般要求
【标准号】:BSEN12011-1998
【标准状态】:作废
【国别】:英国
【发布日期】:1998-05-15
【实施或试行日期】:1998-05-15
【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】:化学成分;材料;铁素体钢;选择;灭菌;等级(质量);生产;沉淀硬化;手术器械;设计;外科设备;成份允差;外科植入物;奥氏体钢;不锈钢;马氏体钢;使用说明;医疗器械;性能;检验;包装
【英文主题词】:Bearings;Biologicalhazards;Checks;Clinical;Composition;Damage;Definitions;Design;Evaluations;Generalconditions;Implants(surgical);Inactive;Instructionsforuse;Instruments;Marking;Materials;Measurement;Medicalequipment;Medicalsciences;Packages;Production;Protection;Selection;Specification(approval);Sterile;Sterilization(hygiene);Surgery;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Transport
【摘要】:ThisEuropeanStandardspecifiesgeneralrequirementsforinstrumentstobeusedinassociationwithnon-activesurgicalimplants.Theserequirementsapplytoinstrumentswhentheyaremanufacturedandwhentheyarere-suppliedafterrefurbishment.Thisstandardappliestoinstrumentswhichmaybeconnectedtopowereddrivensystems,butdoesnotapplytothepowereddrivensystemitself.Thisstandardisnotapplicabletoinstrumentsassociatedwithdentalimplants,transendodonticandtransradicularimplantsandophthalmicimplants.Withregardtosafely,thisstandardgivesrequirementsforintendedperformance,designattributes,materials,designevaluation,manufacture,sterilization,packagingandinformationsuppliedbythemanufacturer.
【中国标准分类号】:C35
【国际标准分类号】:11_040_30
【页数】:14P;A4
【正文语种】:英语
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