【英文标准名称】:Dentistry-Medicaldevicesfordentistry-Equipment;GermanversionEN1640:2009
【原文标准名称】:牙科学.牙科用医疗器械.设备.德文版本EN1640-2009
【标准号】:DINEN1640-2010
【标准状态】:现行
【国别】:德国
【发布日期】:2010-02
【实施或试行日期】:
【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】:校验指示;化学性质;布;组件;触点;制造日期;定义;牙科设备;牙科器械;牙科学;设计;电能;电气安全性;电学;能量;能源;环境条件;设备;外部;气体;危害;保健;液压装置;杂质;信息;使用说明书;加标签;作标记;材料;医疗器械;医疗设备;医疗产品;医学科学;噪声(环境的);物理性能;气动力学;特性;保护(装置);辐射;辐射防护;残留物;安全性要求;规范(验收);稳定性;表面;符号;指示器;温度;试验;振动
【英文主题词】:Checkindication;Chemicalproperties;Cloth;Components;Contact;Dataofthemanufacturer;Definitions;Dentalequipment;Dentalinstruments;Dentistry;Design;Electricenergy;Electricalsafety;Electricity;Energy;Energysources;Environmentalcondition;Equipment;External;Gases;Hazards;Healthprotection;Hydraulics;Impurities;Information;Instructionsforuse;Labelling;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Noise(environmental);Physicalproperties;Pneumatics;Properties;Protection;Radiation;Radiationprotection;Residues;Safetyrequirements;Specification(approval);Stability;Surfaces;Symbols;Telltales;Temperature;Testing;Vibration
【摘要】:ThisEuropeanStandardspecifiesgeneralrequirementsforitemsofdentalequipmentusedinthepracticeofdentistryandwhicharemedicaldevices.Itincludesrequirementsforintendedperformance,designattributes,components,packaging,marking,labelling,andinformationsuppliedbythemanufacturer.ThisEuropeanStandarddoesnotincluderequirementsfordentalX-rayequipment.ThisEuropeanStandarddoesnotapplytoanydentalinstrumentsconnectedtoanitemofdentalequipment.Theseinstrumentsarecoveredbythelevel2andlevel3standardsfordentalinstruments.Testsfordemonstratingcompliancewiththisstandardarecontainedinthelevel3standards,ifappropriate.
【中国标准分类号】:C33
【国际标准分类号】:11_060_20
【页数】:14P.;A4
【正文语种】:英语