【英文标准名称】:Dentistry-Medicaldevicesfordentistry-Instruments
【原文标准名称】:牙科学.牙科用医疗器械.仪器
【标准号】:BSEN1639-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【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】:检查指标;化学性质;分类;布;组件;连接;触点;制造日期;定义;交货条件;牙科设备;牙科器械;牙科学;设计;电能;电击;电气安全;电学;能量;能源;环境条件;危害;液压装置;杂质;指示;信息;使用说明;仪器;加标签;标志;材料性能;医疗器械;医疗设备;医疗仪器;医疗产品;医学科学;微生物分析;噪声(环境的);性能要求;物理性能;气动力学;性能;保护(装置);残留物;安全要求;规范(验收);状况;消毒;表面;符号;指示器;温度;测试;振动
【英文主题词】:Checkindication;Chemicalproperties;Classification;Cloth;Components;Connections;Contact;Dataofthemanufacturer;Definitions;Deliveryconditions;Dentalequipment;Dentalinstruments;Dentistry;Design;Electricenergy;Electricshock;Electricalsafety;Electricity;Energy;Energysources;Environmentalcondition;Hazards;Hydraulics;Impurities;Indications;Information;Instructionsforuse;Instruments;Labelling;Marking;Materialproperties;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Microbiologicalanalysis;Noise(environmental);Performancerequirements;Physicalproperties;Pneumatics;Properties;Protection;Residues;Safetyrequirements;Specification(approval);Status;Sterile;Surfaces;Symbols;Telltales;Temperature;Testing;Vibration
【摘要】:ThisEuropeanStandardspecifiesgeneralrequirementsforinstrumentsusedinthepracticeofdentistryandwhicharemedicaldevices.Itincludesrequirementsforintendedperformance,designattributes,components,reprocessing,packaging,marking,labelling,andinformationsuppliedbythemanufacturer.ThisEuropeanStandarddoesnotapplytoanynecessaryenergysourcetowhichaninstrumentneedstobeconnected.TheseenergysourcesarecoveredbyEN1640.TestsfordemonstratingcompliancewiththisEuropeanStandardarecontainedinthelevel3standards,ifappropriate.
【中国标准分类号】:C33
【国际标准分类号】:11_060_25
【页数】:18P.;A4
【正文语种】:英语