9342EEC协调标准.doc

93/42/EEC协调标准标准代号标准英文名称标准中文名称被替代的标准对应的国内标准EN285:2006Sterilization-Steamsterilizers-Largesterilizers消毒蒸气消毒大型消毒设备EN285:1996EN375:2001Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforprofessionaluse由生产商提供的专业用活体外诊断试剂的信息EN376:2002Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforself-testing生产者在实验室中用自检测诊断试剂提供信息EN455-1:2000Medicalglovesforsingleuse-Part1:Requirementsandtestingforfreedomfromholes医疗专用手套•防洞要求和试验EN455-1:1993EN455-2:2000Medicalglovesforsingleuse-Part2:Requirementsandtestingforphysicalproperties(includingTechnicalCorrigendum1:1996)医疗专用手套•物理性能要求和试验EN455-2:1995EN455-3:2006Medicalglovesforsingleuse-Part3:Requirementsandtestingforbiologicalevaluation医疗专用手套.生物评价的要求和试验EN455-3:1999EN556-1:2001Sterilizationofmedicaldevices-Requirementsformedicaldevicestobedesignated"STERILE"-Part1:RequirementsforterminallysterilizedmedicaldevicesEN556-l:2001/AC:2006医疗设备的灭菌•拟被认定为无菌的医疗设备的要求.对最终灭菌设备的要求EN556:1994+A1:1998EN556-2:2003Sterilizationofmedicaldevices-Requirementsformedicaldevicestobedesignated"STERILE"-Part2:Requirementsforasepticallyprocessedmedicaldevices医疗器械的消毒标明为“消过毒”的医疗器械的要求第2部分：消毒处理的医疗器械的要求EN591:2001Instructionsforuseforinvitrodiagnosticinstrumentsfor专用试管诊断仪的使用professionaluse说明EN592:2002Instructionsforuseforinvitrodiagnosticinstrumentsforself-testing实验室条件下自测试诊断仪的使用说明EN737-1:1998Medicalgaspipelinesystems-Part1:Terminalunitsforcompressedmedicalgasesandvacuum医疗气体管道系统.压缩医疗气体用终端设备和真空终端设备EN737-4:1998Medicalgaspipelinesystems-Part4:Terminalunitsforanaestheticgasscavengingsystems医疗气体管道系统.麻醉气体净化系统的终端设备EN738-4:1998Pressureregulatorsforusewithmedicalgases-Part4:Low-pressureregulatorsintendedforincorporationintomedicalequipmentEN738-4:1998/A1:2002医用气体用压力调节器.医疗设备用低压压力调节器Note3EN739:1998Low-pressurehoseassembliesforusewithmedicalgasesEN739:1998/A1:2002医疗气体设备用低压软管组件Note3EN740:1998Anaestheticworkstationsandtheirmodules-ParticularrequirementsEN740:1998/A1:2004EN740:1998/AC:1998麻醉工作站及其工作舱特殊要求Note3EN794-1:1997Lungventilators-Part1:ParticularrequirementsforcriticalcareventilatorsEN794-1:1997/A1:2000肺呼吸器•临危看护呼吸器的特殊要求Note3EN794-3:1998Lungventilators-Part3:ParticularrequirementsforemergencyandtransportventilatorsEN794-3:1998/A1:2005肺呼吸器•紧急情况和移动通风器的特殊要求Note3EN980:2003Graphicalsymbolsforuseinthelabellingofmedicaldevices医疗器械标签用图形符号EN980:1996EN1041:1998Informationsuppliedbythemanufacturerwithmedical医疗产品生产者提供的devices信息EN1060-1:1995Non-invasivesphygmomanometers-Part1:GeneralrequirementsEN1060-1:1995/A1:2002非侵入式血压计•第1部分:一般要求.修改件A1Note3EN1060-2:1995Non-invasivesphygmomanometers-Part2:Supplementaryrequirementsformechanicalsphygmomanometers非侵入式血压表•第2部分:机械血压表的补充要求EN1060-3:1997Non-invasivesphygmomanometers-Part3:Supplementaryrequirementsforelectro-mechanicalbloodpressuremeasuringsystemsEN1060-3:1997/A1:2005非侵入式血压表•第3部分:电机血压表的补充要求Note3EN1060-4:2004Non-invasivesphygmomanometers-Part4:Testprocedurestodeterminetheoverallsystemaccuracyofautomatednon-invasivesphygmomanometers非介入式血压计•第4部分：自动非介入式血压计整体系统精确度测定的试验过程EN1089-3:2004Transportablegascylinders-Gascylinderidentification(excludingLPG)-Part3:Colourcoding可移动式气瓶•气瓶标识（不包括LPG）•第3部分:色码EN1089-3:1997EN1280-1:1997Agentspecificfillingsystemsforanaestheticvaporizers-Part1:RectangularkeyedfillingsystemsEN1280-1:1997/A1:2000麻醉气化装置制剂特殊添充系统•拒形键控填充系统Note3EN1281-2:1995Anaestheticandrespiratoryequipment-Conicalconnectors-Part2:Screw-threadedweight-bearingconnectors(ISO5356-2:1987modified)麻醉和呼吸设备圆锥形接头第2部分：螺纹承重连接头EN1282-2:2005Tracheostomytubes-Part2:Paediatrictubes(ISO5366-3:2001,modified)气体切开插管•第2部分：儿科婴幼儿用管EN1282-2:1997EN1422:1997Sterilizersformedicalpurposes-Ethyleneoxidesterilizers-医用灭菌器.环氧乙烷灭Requirementsandtestmethods菌器.要求和检验方法EN1618:1997Cathetersotherthanintravascularcatheters-Testmethodsforcommonproperties=管内导管除外的其它导管•通用性能的测试法EN1639:2004Dentistry-Medicaldevicesfordentistry-Instruments牙科学•牙科用医疗装置.器械EN1639:1996EN1640:2004Dentistry-Medicaldevicesfordentistry-Equipment牙科学•牙科用医疗装置.设备EN1640:1996EN1641:2004Dentistry-Medicaldevicesfordentistry-Materials牙科学•牙科用医疗装置.材料EN1641:1996EN1642:2004Dentistry-Medicaldevicesfordentistry-Dentalimplants牙科学•牙科用医疗装置.牙科植入物EN1642:1996EN1707:1996Conicalfittingswitha6%(Luer)taperforsyringes,needlesandcertainothermedicalequipment-Lockfittings注射器、针头和其它特定医疗器械用有6%（路厄）锥度的圆锥形配件•锁定配件EN1782:1998Trachealtubesandconnectors气管和连接件EN1820:2005Anaestheticreservoirbags(ISO5362:2000,modified)麻醉贮袋EN1820:1997EN1865:1999Specificationsforstretchersandotherpatienthandlingequipmentusedinroadambulances救护车里的担架和其他病人运送设备规范EN1970:2000Adjustablebedsfordisabledpersons-RequirementsandtestmethodsEN1970:2000/A1:2005残疾人用可调整的床•要求。