BS EN 1639-2004 牙科学.牙科用医疗装置.器械

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【英文标准名称】:Dentistry-Medicaldevicesfordentistry-Instruments
【原文标准名称】:牙科学.牙科用医疗装置.器械
【标准号】:BSEN1639-2004
【标准状态】:作废
【国别】:英国
【发布日期】:2004-06-11
【实施或试行日期】:2004-06-11
【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】:特性;医疗设备;牙科器械;消毒;交货条件;医学科学;电气安全;仪器;试验;性能要求;牙科设备;材料性能;安全要求;设计;分类系统;规范(验收);制造日期;定义;使用说明;牙科学;危害;化学性质;医疗器械;微生物分析;信息;加标签;医疗产品;物理性能;作标记
【英文主题词】:Checkindication;Chemicalproperties;Classificationsystems;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,sterilization,packaging,marking,labelling,andinformationsuppliedbythemanufacturer.ThisEuropeanStandarddoesnotapplytoanynecessaryenergysourcetowhichaninstrumentneedstobeconnected.Theseenergysourcesarecoveredbythelevel2andlevel3standards,fordentalequipment.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