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:RequirementsforterminallysterilizedmedicaldevicesEN556-1:2001/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EN591:2001Instructionsforuseforinvitrodiagnosticinstrumentsforprofessionaluse专用试管诊断仪的使用说明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:Particularrequirementsfo