欧盟标准清单

受控标准清单欧盟标准（CE认证的标准首先是EN标准、其次为ISO标准）序号标准编号(new)标记为2010.7.7日新修订的欧盟标准标准名称文件来源实施时间现行的国际标准1MDD法规欧洲共同体理事会法令（93/42/EEC）关于医疗器械的规定（MDD法规）外来文件1993.6.142EN1422:1997+A1:2009医用消毒器--环氧乙烷灭菌器要求和测试方法外来文件1997.93EN1041:2008Informationsuppliedbythemanufacturerwithmedicaldevices制造商提供的器械信息知识产权19984EN556-1:2001/AC:2006Sterilizationofmedicaldevices-Requirementsformedicaldevicestobedesignated"STERILE"-Part1:Requirementsforterminallysterilizedmedicaldevices外来文件20015EN724:1995EN29001、EN46001及EN29002和EN46002对于无源医疗设备的应用说明外来文件19956医疗器械审核检查 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf medicaldevicicequalitysystemregulationauditchecklist外来文件/798-79-EC体外植入医疗器械指令外来文件8ivd-dd-tfTechnicalFiels/DesignDossiersInvitroDiagnostics-AProposal外来文件/9ivd-dd-tf技术文件/设计档案体外诊断－提案(非受控)公司翻译/10BSEN868-5:1999Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized外来文件199911MEDDEV.2.12-1:2009医疗器械警戒系统指南外来文件2008.1.112EN980:2008Symbolsforuseinthelabellingofmedicaldevices外来文件2010.5.3113BSEN61010-2-040-2005Safetyrequirementsforelectricalequipmentformeasurement,controlandlaboratoryusePart2-040:Particularrequirementsforsterilizersandwasher-disinfectorsusedtotreatmedicalmaterials购买2005.71497/23/EC（PED）压力设备Pressureequipmen购买1997.5.2915CertificationofOEMDevicesOEM设备的认证购买16GHTFSG3N15R8风险管理原则和活动在质量 管理体系 怎么建立质量管理体系环保管理体系it运维服务管理体系质量体系程序文件项目安全生产管理体系 中的实施购买2005.5.2017软件确认基本原则：工业界及FDA人员指南购买2002.1.1118EN1041:2008Informationsuppliedbythemanufacturerwithmedicaldevices制造商提供的器械信息外来文件19ENISO3826-2:2008人类血液及血液成分用塑料可折叠容器.第2部分:用于标签和说明手册上的图形符号外来文件ISO3826-2:200820ENISO3826-3:2007Plasticscollapsiblecontainersforhumanbloodandbloodcomponents-Part3:Bloodbagsystemswithintegratedfeatures(ISO3826-3:2006)外来文件ISO3826-3:200621EN285:2006+A2:2009灭菌-蒸汽灭菌器-大型蒸汽灭菌器外来文件21/03/201022EN1639:2009(new)牙科学牙科用医疗设备-仪器外来文件30/04/201023EN1640:2009(new)牙科-牙科医疗设备-设备外来文件30/04/201024EN1641:2009(new)牙科-牙科医疗器械-材料外来文件30/04/201025EN1642:2009(new)牙科-牙科医疗设备-牙科植入物外来文件30/04/201026ENISO7886-3:2009(new) 一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器外来文件21/03/2010ISO7886-3:200527ENISO7886-4:2009(new)无菌皮下注射器.第4部分:带防止重复使用特性的注射器外来文件21/03/2010ISO7886-4:200628ENISO10993-1:2009Biologicalevaluationofmedicaldevices-Part1:Evaluationandtestingwithinariskmanagementprocess(ISO10993-1:2009)外来文件02/12/2009 ISO10993-1:200929ENISO10993-3:2009Biologicalevaluationofmedicaldevices-Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity(ISO10993-3:2003)外来文件02/12/2009 ISO10993-3:200330ENISO10993-3:2009Biologicalevaluationofmedicaldevices-Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity(ISO10993-3:2003)外来文件02/12/2009 ISO10993-3:200331ENISO10993-4:2009Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforinteractionswithblood(ISO10993-4:2002,includingAmd1:2006)外来文件(ISO10993-4:200232ENISO10993-5:2009Biologicalevaluationofmedicaldevices-Part5:Testsforinvitrocytotoxicity(ISO10993-5:2009)外来文件(ISO10993-5:200933ENISO10993-6:2009Biologicalevaluationofmedicaldevices-Part6:Testsforlocaleffectsafterimplantation(ISO10993-6:2007)外来文件(ISO10993-6:2007)34ENISO10993-7:2008/AC:2009(new)医疗器械的生物学评价　第7部分：环氧乙烷灭菌残留量外来文件19/02/2009ISO10993-7:200835ENISO10993-9:2009Biologicalevaluationofmedicaldevices-Part9:Frameworkforidentificationandquantificationofpotentialdegradationproducts(ISO10993-9:2009)外来文件(ISO10993-9:2009)36ENISO10993-10:2009Biologicalevaluationofmedicaldevices-Part10:Testsforirritationanddelayed-typehypersensitivity(ISO10993-10:2002,includingAmd1:2006)外来文件ISO10993-10:200237ENISO10993-11:2009Biologicalevaluationofmedicaldevices-Part11:Testsforsystemictoxicity(ISO10993-11:2006)外来文件(ISO10993-11:2006)38ENISO10993-12:2009Biologicalevaluationofmedicaldevices-Part12:Samplepreparationandreferencematerials(ISO10993-12:2007)外来文件(ISO10993-12:2007)39ENISO10993-13:2009Biologicalevaluationofmedicaldevices-Part13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices(ISO10993-13:1998)外来文件(ISO10993-13:1998)40ENISO10993-14:2009Biologicalevaluationofmedicaldevices-Part14:Identificationandquantificationofdegradationproductsfromceramics(ISO10993-14:2001)外来文件(ISO10993-14:2001)41ENISO10993-15:2009Biologicalevaluationofmedicaldevices-Part15:Identificationandquantificationofdegradationproductsfrommetalsandalloys(ISO10993-15:2000)外来文件(ISO10993-15:2000)42ENISO10993-16:2010(new) 医疗器械的生物学评价　第16部分：降解产物与可容出物的毒物动力学研究设计外来文件31/08/2010 ISO10993-16:201043ENISO10993-17:2009Biologicalevaluationofmedicaldevices-Part17:Establishmentofallowablelimitsforleachablesubstances(ISO10993-17:2002)外来文件(ISO10993-17:2002)44ENISO10993-18:2009Biologicalevaluationofmedicaldevices-Part18:Chemicalcharacterizationofmaterials(ISO10993-18:2005)外来文件(ISO10993-18:2005)45ENISO11135-1:2007Sterilizationofhealthcareproducts-Ethyleneoxide-Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices(ISO11135-1:2007)外来文件09/08/2007 (ISO11135-1:2007)48ENISO11138-2:2009Sterilizationofhealthcareproducts-Biologicalindicators-Part2:Biologicalindicatorsforethyleneoxidesterilizationprocesses(ISO11138-2:2006)外来文件02/12/2009 (ISO11138-2:2006)49ENISO11138-3:2009Sterilizationofhealthcareproducts-Biologicalindicators-Part3:Biologicalindicatorsformoistheatsterilizationprocesses(ISO11138-3:2006)外来文件02/12/2009 (ISO11138-3:2006)50ENISO11140-1:2009Sterilizationofhealthcareproducts-Chemicalindicators-Part1:Generalrequirements(ISO11140-1:2005)外来文件02/12/2009 (ISO11140-1:2005)51ENISO11140-3:2009Sterilizationofhealthcareproducts-Chemicalindicators-Part3:Class2indicatorsystemsforuseintheBowieandDick-typesteampenetrationtest(ISO11140-3:2007,includingCor1:2007)外来文件02/12/2009 (ISO11140-3:2007,includingCor1:2007)52ENISO11197:2009Medicalsupplyunits(ISO11197:2004)外来文件02/12/2009 (ISO11197:2004)53ENISO11607-1:2009Packagingforterminallysterilizedmedicaldevices-Part1:Requirementsformaterials,sterilebarriersystemsandpackagingsystems(ISO11607-1:2006)外来文件02/12/2009 (ISO11607-1:2006)54ENISO11607-2:2006Packagingforterminallysterilizedmedicaldevices-Part2:Validationrequirementsforforming,sealingandassemblyprocesses(ISO11607-2:2006)外来文件07/09/2006 (ISO11607-2:2006)55ENISO11137-1:2006Sterilizationofhealthcareproducts-Radiation-Part1:Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices(ISO11137-1:2006)外来文件07/09/2006 (ISO11137-1:2006)56ENISO11737-1:2006/AC:2009Sterilizationofmedicaldevices-Microbiologicalmethods-Part1:Determinationofapopulationofmicroorganismsonproducts(ISO11737-1:2006)外来文件02/12/2009 57ENISO11737-2:2009(new)医疗器械的灭菌.微生物法.第2部分:灭菌方法验证中进行的无菌检验外来文件09/08/2007 ISO11737-2:200958EN12342:1998+A1:2009(new)配合麻醉装置和通风器使用的呼吸管外来文件21/03/201059EN13060:2004+A2:2010(new)小型蒸汽消毒器外来文件30/09/2010 60ENISO13485:2003/AC:2009(new)医疗器械质量管理体系用于法规的要求外来文件61EN13726-1:2002Testmethodsforprimarywounddressings-Part1:Aspectsofabsorbency外来文件27/03/2003 62EN13726-1:2002/AC:2003外来文件02/12/2009 63EN13726-2:2002Testmethodsforprimarywounddressings-Part2:Moisturevapourtransmissionrateofpermeablefilmdressings外来文件27/03/2003 64EN13727:2003Chemicaldisinfectantsandantiseptics-Quantitativesuspensiontestfortheevaluationofbactericidalactivityofchemicaldisinfectantsforinstrumentsusedinthemedicalarea-Testmethodandrequirements(phase2,step1)外来文件30/09/2005 65EN13867:2002+A1:2009Concentratesforhaemodialysisandrelatedtherapies外来文件02/12/2009 66外来文件67ENISO14155-2:2009(new)用于人体的医疗器械的临床研究　第2部分 临床调查计划外来文件21/03/2010ISO14155-2:200368EN14180:2003+A2:2009(new)医用消毒灭菌器低温蒸汽甲醛灭菌器要求和检测外来文件21/03/201069ENISO14937:2009(new)医疗器械的消毒 产品的微生物总数的估算 第3部分：微生物技术确认方法指南外来文件30/04/2010ISO14937:200970ENISO14971:2009(new)风险管理对医疗器械的应用外来文件21/03/2010ISO14971:200771ENISO16061:2009(new)与非有源外科植入物相关的仪器.一般要求外来文件28/02/2010ISO16061:2008,72ENISO21649:2009(new)医用非针头式注射器要求和试验方法外来文件21/03/2010ISO21649:200673ENISO26782:2009(new)麻醉呼吸机外来文件(ISO26782:2009)74EN60601-2-2:2009(new)医用电气设备—第2-2部分：高频外科设备安全性专门要求外来文件IEC60601-2-2:2009ESO(1)FirstpublicationOJReferenceofsupersededstandard被取代的参考标准DateofcessationofpresumptionofconformityofsupersededstandardReferenceandtitleoftheharmonisedstandard(andreferencedocument)Note1CENEN285:2006+A2:2009EN285:2006+A2:200902/12/2009 EN285:2006+A1:2008DateexpiredSterilization-Steamsterilizers-Largesterilizers灭菌-蒸汽灭菌器-大型蒸汽灭菌器(21/03/2010) Note2.1 CENEN455-1:2000EN455-1:200030/09/2005 EN455-1:1993DateexpiredMedicalglovesforsingleuse-Part1:Requirementsandtestingforfreedomfromholes一次性使用的医疗手套第1部分：防洞要求和测试英文标准(30/04/2001) Note2.1 CENEN455-2:2009(new)EN455-2:2009(new)Thisisthefirstpublication EN455-2:2000DateexpiredMedicalglovesforsingleuse-Part2:Requirementsandtestingforphysicalproperties一次性医疗用手套.物理性能要求和试验(31/05/2010) Note2.1 CENEN455-3:2006EN455-3:200609/08/2007 EN455-3:1999DateexpiredMedicalglovesforsingleuse-Part3:Requirementsandtestingforbiologicalevaluation一次性医疗用手套.生物评价的要求和试验(30/06/2007) Note2.1 CENEN455-4:2009(new)EN455-4:2009(new)Thisisthefirstpublication Medicalglovesforsingleuse-Part4:Requirementsandtestingforshelflifedetermination一次性医疗用手套.货架寿命的要求和试验测定CENEN556-1:2001EN556-1:200131/07/2002 EN556:1994+A1:1998DateexpiredSterilizationofmedicaldevices-Requirementsformedicaldevicestobedesignated"STERILE"-Part1:Requirementsforterminallysterilizedmedicaldevices标示无菌医疗器械的要求第1部分:最终灭菌医疗器械的要求(30/04/2002) Note2.1 EN556-1:2001/AC:200615/11/2006 CENEN556-2:2003EN556-2:200309/08/2007 Sterilizationofmedicaldevices-Requirementsformedicaldevicestobedesignated"STERILE"-Part2:RequirementsforasepticallyprocessedmedicaldevicesCENEN794-1:1997+A2:200902/12/2009 EN794-1:1997DateexpiredLungventilators-Part1:Particularrequirementsforcriticalcareventilators(21/03/2010) Note2.1 CENEN794-3:1998+A2:2009(new)EN794-3:1998+A2:2009(new)Thisisthefirstpublication EN794-3:1998DateexpiredLungventilators-Part3:Particularrequirementsforemergencyandtransportventilators(21/03/2010) Note2.1 CENEN980:200823/07/2008 EN980:2003DateexpiredSymbolsforuseinthelabellingofmedicaldevices(31/05/2010) Note2.1 CENEN1041:200819/02/2009 EN1041:199831/08/2011 InformationsuppliedbythemanufacturerofmedicaldevicesNote2.1 CENEN1060-1:1995+A2:2009(new)EN1060-1:1995+A2:2009(new)Thisisthefirstpublication Non-invasivesphygmomanometers-Part1:Generalrequirements非侵入式血压计.第1部分:一般要求CENEN1060-2:1995+A1:2009(new)EN1060-2:1995+A1:2009(new)Thisisthefirstpublication EN1060-2:1995DateexpiredNon-invasivesphygmomanometers-Part2:Supplementaryrequirementsformechanicalsphygmomanometers非侵入式血压计第2部分：机械血压计的补充要求(31/05/2010) Note2.1 CENEN1060-3:1997+A2:2009(new)EN1060-3:1997+A2:2009(new)Thisisthefirstpublication EN1060-3:1997DateexpiredNon-invasivesphygmomanometers-Part3:Supplementaryrequirementsforelectro-mechanicalbloodpressuremeasuringsystems非侵入式血压计第3部分：电动机械血压测量系统的补充要求(31/05/2010) Note2.1 CENEN1060-4:200430/09/2005 Non-invasivesphygmomanometers-Part4:Testprocedurestodeterminetheoverallsystemaccuracyofautomatednon-invasivesphygmomanometersCENEN1089-3:200430/09/2005 EN1089-3:1997DateexpiredTransportablegascylinders-Gascylinderidentification(excludingLPG)-Part3:Colourcoding(31/10/2004) Note2.1 CENEN1282-2:2005+A1:2009(new)EN1282-2:2005+A1:2009(new)Thisisthefirstpublication EN1282-2:2005DateexpiredTracheostomytubes-Part2:Paediatrictubes(ISO5366-3:2001,modified)气管造口插管.第2部分:儿科用管(21/03/2010) Note2.1 CENEN1422:1997+A1:200902/12/2009 EN1422:1997DateexpiredSterilizersformedicalpurposes-Ethyleneoxidesterilizers-Requirementsandtestmethods(21/03/2010) Note2.1 CENEN1618:199709/05/1998 Cathetersotherthanintravascularcatheters-TestmethodsforcommonpropertiesCENEN1639:2009(new)EN1639:2009(new)Thisisthefirstpublication EN1639:2004DateexpiredDentistry-Medicaldevicesfordentistry-Instruments牙科学牙科用医疗设备-仪器(30/04/2010) Note2.1 CENEN1640:2009(new)EN1640:2009(new)Thisisthefirstpublication EN1640:2004DateexpiredDentistry-Medicaldevicesfordentistry-Equipment牙科-牙科医疗设备-设备(30/04/2010) Note2.1 CENEN1641:2009(new)EN1641:2009(new)Thisisthefirstpublication EN1641:2004DateexpiredDentistry-Medicaldevicesfordentistry-Materials牙科-牙科医疗器械-材料(30/04/2010) Note2.1 CENEN1642:2009(new)EN1642:2009(new)Thisisthefirstpublication EN1642:2004DateexpiredDentistry-Medicaldevicesfordentistry-Dentalimplants牙科-牙科医疗设备-牙科植入物(30/04/2010) Note2.1 CENEN1707:199617/05/1997 Conicalfittingswitha6%(Luer)taperforsyringes,needlesandcertainothermedicalequipment-LockfittingsCENEN1782:1998+A1:2009(new)EN1782:1998+A1:2009(new)Thisisthefirstpublication EN1782:1998DateexpiredTrachealtubesandconnectors气管导管和连接器(21/03/2010) Note2.1 CENEN1789:200723/07/2008 EN1789:1999DateexpiredMedicalvehiclesandtheirequipment-Roadambulances(30/11/2007) Note2.1 ThisstandardstillneedstobeamendedtotakeintoaccounttherequirementsintroducedbyDirective2007/47/EC.TheamendedstandardwillbepublishedbyCENassoonaspossible.ManufacturersareadvisedtocheckwhetherallrelevantEssentialRequirementsoftheamendeddirectiveareappropriatelycovered.CENEN1820:2005+A1:2009(new)EN1820:2005+A1:2009(new)Thisisthefirstpublication EN1820:2005DateexpiredAnaestheticreservoirbags(ISO5362:2000,modified)麻醉储藏袋(21/03/2010) Note2.1 CENEN1865:199914/10/2000 SpecificationsforstretchersandotherpatienthandlingequipmentusedinroadambulancesCENEN1970:200014/11/2001 Adjustablebedsfordisabledpersons-RequirementsandtestmethodsEN1970:2000/A1:200530/09/2005 Note3 Dateexpired(30/09/2005) CENEN1985:199810/08/1999 Walkingaids-GeneralrequirementsandtestmethodsThisstandardstillneedstobeamendedtotakeintoaccounttherequirementsintroducedbyDirective2007/47/EC.TheamendedstandardwillbepublishedbyCENassoonaspossible.ManufacturersareadvisedtocheckwhetherallrelevantEssentialRequirementsoftheamendeddirectiveareappropriatelycovered.CENENISO3826-2:2008ENISO3826-2:200819/02/2009 Plasticscollapsiblecontainersforhumanbloodandbloodcomponents-Part2:Graphicalsymbolsforuseonlabelsandinstructionleaflets(ISO3826-2:2008)人类血液及血液成分用塑料可折叠容器.第2部分:用于标签和说明手册上的图形符号CENENISO3826-3:200727/02/2008 Plasticscollapsiblecontainersforhumanbloodandbloodcomponents-Part3:Bloodbagsystemswithintegratedfeatures(ISO3826-3:2006)CENENISO4074:200231/07/2002 EN600:1996DateexpiredNaturallatexrubbercondoms-Requirementsandtestmethods(ISO4074:2002)(31/08/2005) Note2.1 ENISO4074:2002/AC:200802/12/2009 CENENISO4135:200131/07/2002 ENISO4135:1996DateexpiredAnaestheticandrespiratoryequipment-Vocabulary(ISO4135:2001)(28/02/2002) Note2.1 CENENISO5356-1:200430/09/2005 EN1281-1:1997DateexpiredAnaestheticandrespiratoryequipment-Conicalconnectors-Part1:Conesandsockets(ISO5356-1:2004)(30/11/2004) Note2.1 CENENISO5356-2:200709/11/2007 EN1281-2:1995DateexpiredAnaestheticandrespiratoryequipment-Conicalconnectors-Part2:Screw-threadedweight-bearingconnectors(ISO5356-2:2006)(29/02/2008) Note2.1 CENENISO5359:200823/07/2008 EN739:199830/06/2010 Low-pressurehoseassembliesforusewithmedicalgases(ISO5359:2008)Note2.1 CENENISO5360:200902/12/2009 ENISO5360:2007DateexpiredAnaestheticvaporizers-Agent-specificfillingsystems(ISO5360:2006)(21/03/2010) Note2.1 CENENISO5366-1:200902/12/2009 ENISO5366-1:2004DateexpiredAnaestheticandrespiratoryequipment-Tracheostomytubes-Part1:Tubesandconnectorsforuseinadults(ISO5366-1:2000)(21/03/2010) Note2.1 CENENISO5840:200902/12/2009 ENISO5840:2005DateexpiredCardiovascularimplants-Cardiacvalveprostheses(ISO5840:2005)(21/03/2010) Note2.1 CENENISO7197:200902/12/2009 ENISO7197:2006DateexpiredNeurosurgicalimplants-Sterile,single-usehydrocephalusshuntsandcomponents(ISO7197:2006,includingCor1:2007)(21/03/2010) Note2.1 CENENISO7376:200902/12/2009 ENISO7376:2009DateexpiredAnaestheticandrespiratoryequipment-Laryngoscopesfortrachealintubation(ISO7376:2009)(21/03/2010) Note2.1 CENENISO7396-1:200709/08/2007 EN737-3:1998DateexpiredMedicalgaspipelinesystems-Part1:Pipelinesystemsforcompressedmedicalgasesandvacuum(ISO7396-1:2007)(30/04/2009) Note2.1 ENISO7396-1:2007/A1:2010(new)医用气体管道系统.第1部分:压缩医疗气体和真空用管道系统Thisisthefirstpublication Note3 31/07/2010 ENISO7396-1:2007/A2:2010(new)Thisisthefirstpublication Note3 31/08/2010 CENENISO7396-2:200709/08/2007 EN737-2:1998DateexpiredMedicalgaspipelinesystems-Part2:Anaestheticgasscavengingdisposalsystems(ISO7396-2:2007)(30/04/2009) Note2.1 CENENISO7439:200902/12/2009 ENISO7439:2002DateexpiredCopper-bearingintra-uterinecontraceptivedevices-Requirements,tests(ISO7439:2002)(21/03/2010) Note2.1 CENENISO7886-3:2009(new)ENISO7886-3:2009(new)Thisisthefirstpublication ENISO7886-3:2005DateexpiredSterilehypodermicsyringesforsingleuse-Part3:Auto-disablesyringesforfixed-doseimmunization(ISO7886-3:2005) 一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器(21/03/2010) Note2.1 CENENISO7886-4:2009(new)ENISO7886-4:2009(new)Thisisthefirstpublication ENISO7886-4:2006DateexpiredSterilehypodermicsyringesforsingleuse-Part4:Syringeswithre-usepreventionfeature(ISO7886-4:2006)无菌皮下注射器.第4部分:带防止重复使用特性的注射器(21/03/2010) Note2.1 CENENISO8185:200902/12/2009 ENISO8185:2007DateexpiredRespiratorytracthumidifiersformedicaluse-Particularrequirementsforrespiratoryhumidificationsystems(ISO8185:2007)(21/03/2010) Note2.1 CENENISO8359:200902/12/2009 ENISO8359:1996DateexpiredOxygenconcentratorsformedicaluse-Safetyrequirements(ISO8359:1996)(21/03/2010) Note2.1 CENENISO8536-4:200709/08/2007 Infusionequipmentformedicaluse-Part4:Infusionsetsforsingleuse,gravityfeed(ISO8536-4:2007)CENENISO8835-2:200902/12/2009 ENISO8835-2:2007DateexpiredInhalationalanaesthesiasystems-Part2:Anaestheticbreathingsystems(ISO8835-2:2007)(21/03/2010) Note2.1 CENENISO8835-3:200902/12/2009 ENISO8835-3:2007DateexpiredInhalationalanaesthesiasystems-Part3:Transferandreceivingsystemsofactiveanaestheticgasscavengingsystems(ISO8835-3:2007)(21/03/2010) Note2.1 CENENISO8835-4:200902/12/2009 ENISO8835-4:2004DateexpiredInhalationalanaesthesiasystems-Part4:Anaestheticvapourdeliverydevices(ISO8835-4:2004)(21/03/2010) Note2.1 CENENISO8835-5:200902/12/2009 ENISO8835-5:2004DateexpiredInhalationalanaesthesiasystems-Part5:Anaestheticventilators(ISO8835-5:2004)(21/03/2010) Note2.1 CENENISO9170-1:200819/02/2009 EN737-1:199831/07/2010 Terminalunitsformedicalgaspipelinesystems-Part1:Terminalunitsforusewithcompressedmedicalgasesandvacuum(ISO9170-1:2008)Note2.1 CENENISO9170-2:200819/02/2009 EN737-4:199831/07/2010 Terminalunitsformedicalgaspipelinesystems-Part2:Terminalunitsforanaestheticgasscavengingsystems(ISO9170-2:2008)Note2.1 CENENISO9360-1:200902/12/2009 ENISO9360-1:2000DateexpiredAnaestheticandrespiratoryequipment-Heatandmoistureexchangers(HMEs)forhumidifyingrespiredgasesinhumans-Part1:HMEsforusewithminimumtidalvolumesof250ml(ISO9360-1:2000)(21/03/2010) Note2.1 CENENISO9360-2:200902/12/2009 ENISO9360-2:2002DateexpiredAnaestheticandrespiratoryequipment-Heatandmoistureexchangers(HMEs)forhumidifyingrespiredgasesinhumans-Part2:HMEsforusewithtracheostomizedpatientshavingminimumtidalvolumesof250ml(ISO9360-2:2001)(21/03/2010) Note2.1 CENENISO9713:200902/12/2009 ENISO9713:2004DateexpiredNeurosurgicalimplants-Self-closingintracranialaneurysmclips(ISO9713:2002)(21/03/2010) Note2.1 CENENISO9919:200902/12/2009 ENISO9919:2005DateexpiredMedicalelectricalequipment-Particularrequirementsforthebasicsafetyandessentialperformanceofpulseoximeterequipmentformedicaluse(ISO9919:2005)(21/03/2010) Note2.1 CENENISO10079-1:200902/12/2009 ENISO10079-1:1999DateexpiredMedicalsuctionequipment-Part1:Electricallypoweredsuctionequipment-Safetyrequirements(ISO10079-1:1999)(21/03/2010) Note2.1 CENENISO10079-2:200902/12/2009 ENISO10079-2:1999DateexpiredMedicalsuctionequipment-Part2:Manuallypoweredsuctionequipment(ISO10079-2:1999)(21/03/2010) Note2.1 CENENISO10079-3:200902/12/2009 ENISO10079-3:1999DateexpiredMedicalsuctionequipment-Part3:Suctionequipmentpoweredfromavacuumorpressuresource(ISO10079-3:1999)(21/03/2010) Note2.1 CENENISO10328:200609/08/2007 Prosthetics-Structuraltestingoflower-limbprostheses-Requirementsandtestmethods(ISO10328:2006)ThisstandardstillneedstobeamendedtotakeintoaccounttherequirementsintroducedbyDirective2007/47/EC.TheamendedstandardwillbepublishedbyCENassoonaspossible.ManufacturersareadvisedtocheckwhetherallrelevantEssentialRequirementsoftheamendeddirectiveareappropriatelycovered.CENENISO10524-1:200602/06/2006 EN738-1:1997DateexpiredPressureregulatorsforusewithmedicalgases-Part1:Pressureregulatorsandpressureregulatorswithflow-meteringdevices(ISO10524-1:2006)(31/10/2008) Note2.1 CENENISO10524-2:200607/06/2009 EN738-2:1998DateexpiredPressureregulatorsforusewithmedicalgases-Part2:Manifoldandlinepressureregulators(ISO10524-2:2005)(31/10/2008) Note2.1 CENENISO10524-3:200607/09/2006 EN738-3:1998Dat