DIN EN ISO 13485-2003 医疗装置.质量管理体系.管理要求
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【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2003);GermanversionENISO13485:2003
【原文标准名称】:医疗装置.质量管理体系.管理要求
【标准号】:DINENISO13485-2003
【标准状态】:作废
【国别】:德国
【发布日期】:2003-11
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Theprojectspecifiesrequirementsforaqualitymanagementsystemwhereanorganisationneedstodemonstrateitsabilitytoprovidemedicaldevicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevices.DifferentfromDINENISO13485:2001-02andDINENISO13488:2001-02,therevisedstandardDINISO13485isastand-alonestandard.OrganisationswhosequalitymanagementsystemsconformtoDINISO13485cannotclaimconformitytoISO9001:2000unlesstheirqualitymanagementsystemsconformtotheadditionalISO9001:2000requirements.#,,#
【中国标准分类号】:C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:73P;A4
【正文语种】:德语
【英文标准名称】:StandardSpecificationforSpillResistantFuelingSystemsforPortableFuelContainersforConsumerUse
【原文标准名称】:消费者使用的便携燃料容器用防溢型加燃料系统的标准规范
【标准号】:ASTMF2234-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:燃烧器;燃料容器;燃料;汽油;煤油;汽油罐;便携的
【英文主题词】:Burners;Fuelcontainers;Fuels;Gasoline;Kerosine;Petroltanks;Portable
【摘要】:
【中国标准分类号】:
【国际标准分类号】:75_200
【页数】:6P;A4
【正文语种】:英语
【英文标准名称】:Powerinstallationsexceeding1kVa.c.-Part1:Commonrules
【原文标准名称】:交流电压大于1kV的电力装置.第1部分:通用规则
【标准号】:IEC61936-1-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-08
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/TC99
【标准类型】:()
【标准水平】:()
【中文主题词】:电容器;扼流圈;接触安全装置;定义;设计;电缆;电接触保护;电力传输线路;电气工程;电气设备;电气保护设备;电气安全性;电驱动装置;设备;安装;熔断器;高电压;高压电器;户内电气设备;装配;仪表用变压器;绝缘件;避雷防护;场所;名义交流电压;职业安全;室外电站;过电压保护装置;电力电缆;电力装置;防电击;保护措施;安全性;安全措施;安全性要求;开关设备;变压器
【英文主题词】:Capacitors;Chokes(electric);Contactsafetydevices;Definitions;Design;Electriccables;Electriccontactprotection;Electricpowertransmissionlines;Electricalengineering;Electricalequipment;Electricalprotectionequipment;Electricalsafety;Electrically-operateddevices;Equipment;Erection;Fuses;Highvoltage;High-voltageequipment;Indoorelectricequipment;Installation;Instrumenttransformers;Insulations;Lightningprotection;Locations;Nominalalternatingvoltages;Occupationalsafety;Outdoorstations;Overvoltageprotection;Powercables;Powerinstallations;Protectionagainstelectricshocks;Protectivemeasures;Safety;Safetymeasures;Safetyrequirements;Switchgear;Transformers
【摘要】:ThispartofIEC61936providescommonrulesforthedesignandtheerectionofelectricalpowerinstallationsinsystemswithnominalvoltagesabove1kVa.c.andnominalfrequencyuptoandincluding60Hz,soastoprovidesafetyandproperfunctioningfortheuseintended.Forthepurposeofinterpretingthisstandard,anelectricalpowerinstallationisconsideredtobeoneofthefollowing:a)Substation,includingsubstationforrailwaypowersupplyb)Electricalinstallationsonmast,poleandtowerSwitchgearand/ortransformerslocatedoutsideaclosedelectricaloperatingareac)One(ormore)powerstation(s)locatedonasinglesiteTheinstallationincludesgeneratorsandtransformerswithallassociatedswitchgearandallelectricalauxiliarysystems.Connectionsbetweengeneratingstationslocatedondifferentsitesareexcluded.d)Theelectricalsystemofafactory,industrialplantorotherindustrial,agricultural,commercialorpublicpremisesTheelectricalpowerinstallationincludes,amongothers,thefollowingequipment:–rotatingelectricalmachines;–switchgear;–transformersandreactors;–converters;–cables;–wiringsystems;–batteries;–capacitors;–earthingsystems;–buildingsandfenceswhicharepartofaclosedelectricaloperatingarea;–associatedprotection,controlandauxiliarysystems;–largeaircorereactor.NOTEIngeneral,astandardforanitemofequipmenttakesprecedenceoverthisstandard.Thisstandarddoesnotapplytothedesignanderectionofanyofthefollowing:–overheadandundergroundlinesbetweenseparateinstallations;–electricrailways;–miningequipmentandinstallations;–fluorescentlampinstallations;–installationsonshipsandoff-shoreinstallations;–electrostaticequipment(e.g.electrostaticprecipitators,spray-paintingunits);–testsites;–medicalequipment,e.g.medicalX-rayequipment.Thisstandarddoesnotapplytothedesignoffactory-built,type-testedswitchgearforwhichseparateIECstandardsexist.Thisstandarddoesnotapplytotherequirementsforcarryingoutliveworkingonelectricalinstallations.Ifnototherwiserequiredinthisstandard,forlow-voltageelectricalinstallationsthestandardseriesIEC60364applies.
【中国标准分类号】:K40
【国际标准分类号】:29_020;29_080_01
【页数】:214P.;A4
【正文语种】:英语
