DIN EN 1041-2008 由医疗装置制造商提供的信息
时间:2024-05-16 00:09:33 来源: 标准资料网 作者：标准资料网 阅读：8888
【英文标准名称】:Informationsuppliedbythemanufacturerofmedicaldevices;GermanversionEN1041:2008
【原文标准名称】:由医疗装置制造商提供的信息
【标准号】:DINEN1041-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-11
【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】:附件;制造日期;定义;绷扎材料;企业;外科植入物;信息;使用说明书;作标记;医疗设备;医疗器械;医疗产品;医学科学;医疗技术学;产品信息;产品;保障;规范(验收);手术敷料;术语
【英文主题词】:Accessories;Dataofthemanufacturer;Definition;Definitions;Dressingmaterials;Enterprises;Implants(surgical);Information;Instructionsforuse;Marking;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Medicaltechnology;Productinformation;Products;Provision;Specification(approval);Surgicaldressings;Terminology
【摘要】:ThisstandardspecifiesrequirementsforinformationtobesuppliedbyamanufacturerformedicaldevicesregulatedbyCouncilDirective90/385/EECrelatingtoactiveimplantablemedicaldevicesandCouncilDirective93/42/EECconcerningmedicaldevices.Itdoesnotspecifythelanguagetobeusedforsuchinformadon,nordoesitspecifythemeansbywhichtheinformationistobesupplied.ItisalsointendedtocomplementthespecificrequirementsofthecitedEUDirectivesonmedicaldevicesbyprovidingguidanceonmeansbywhichcertainrequirementscanbemet.Ifamanufacturerfollowsthesemeans,theywillprovideapresumptionofconformitywiththerelevantEssentialRequirementsregardinginformationtobesupplied.Thisstandarddoesnotcoverrequirementsforprovisionofinformationforinvitrodiagnosticmedicaldevices,whicharecoveredbyotherlabellingstandards(seeBibliography).NOTEWhennationaltranspositionsoftheDirectivesspecifythemeansbywhichinformationshallbesupplied,thisstandarddoesnotprovidederogationfromtheserequirementsforthatcountry.
【中国标准分类号】:C04
【国际标准分类号】:01_110;11_040_01;11_120_01
【页数】:32P.;A4
【正文语种】:德语
【英文标准名称】:Informationtechnology-Officeequipment-Methodformeasuringdigitalprintingproductivity
【原文标准名称】:信息技术.办公设备.数字印刷能力的测量方法
【标准号】:ISO/IEC24734-2009
【标准状态】:现行
【国别】:国际
【发布日期】:2009-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/IECJTC1/SC28
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;数字的;数字工程;效率;信息技术;仪器;测量;测量技术;办公室设备;性能;打印机;印刷;测试;测试条件
【英文主题词】:Definitions;Digital;Digitalengineering;Efficiency;Informationtechnology;Instruments;Measurement;Measuringtechniques;Officeequipment;Performance;Printers;Printing;Testing;Testingconditions
【摘要】:ThisInternationalStandardspecifiesamethodformeasuringtheproductivityofdigitalprintingdeviceswithvariousofficeapplicationsandprintjobcharacteristics.ThisInternationalStandardisapplicabletodigitalprintingdevices,includingsingle-functionandmulti-functiondevices,regardlessofprinttechnology(e.g.inkjet,laser).Devicescanbeequippedwitharangeofpaperfeedandfinishingoptionseitherdirectlyconnectedtothecomputersystemorviaanetwork.Itisintendedtobeusedforblackandwhite(B&W)aswellascolourdigitalprintingdevices.Itallowsforthecomparisonoftheproductivityofmachinesoperatinginvariousavailablemodes(simplex,duplex,sizeofsubstrates,etc.)andofficeapplicationswhenthetestsystemenvironment,operatingmodes,andjobmixforeachmachineareheldidentical.ThisInternationalStandardincludestestfiles,testsetupprocedure,testruntimeprocedure,andthereportingrequirementsforthedigitalprintingproductivitymeasurements.ThisInternationalStandardisnotintendedtobeusedfordeviceswhicharenotabletoprintonamediasizeofA4/8.5”x11”orfordevices,whicharenotabletocollatemultiplecopiesofaprint.ThisInternationalStandardisnotintendedtoreplacemanufacturer'sratedspeeds.Theproductivityofadigitalprintingdevicedependsonfactorsotherthantheprintingdeviceitself.Theseinclude,butarenotlimitedto,computermanufacturerandmodel,centralprocessortypeandspeed,RAMandharddiskmemorycapacityandspeed,softwaredriver,versionoftheapplicationbeingused,operatingsystem,andthetypeandspeedofthecommunicationpathfromcomputertoprintingdevice,etc.Becauseofthis,inordertomakeusefulandaccuratedirectcomparisonsofprintingproductivitywiththisInternationalStandard,thesamecomputersystemhardwareandsoftwareshallbeusedformeasuringtheprintingdevicesifforthepurposeofbeingdirectlycomparedonetoanother.Foreveryprintingproductivitymeasurement,thebasicspecificationsofthecomputerhardwareandsoftwareshallbeincludedwiththeresultsoftheprintingproductivitymeasurement.NOTEImportantnotefortheuseofthisInternationalStandard.Thereareotherfactorsthatinfluencethenumberofprintsthatapersoncanmakeonaprintingdevicewithinadefinedtimeperiod.Thesefactorsincludetypicaljobportfoliothatisprintedonaparticularprintingdevice,reliabilityofthesystem,downtimeduetoaservicecall,ease-of-use,(un)loadpaperduringprinting,routinemaintenance,interactionwithotherusersoftheprintingdeviceandthenetwork,etc.SuchproductivityitemsarenottakenintoaccountwithinthescopeormethodsofthisInternationalStandard.
【中国标准分类号】:Y54
【国际标准分类号】:37_100_10
【页数】:52P.;A4
【正文语种】:英语
【英文标准名称】:Vitreousandporcelainenamels-Glass-linedapparatusforprocessplants-Part1:Qualityrequirementsforapparatus,components,appliancesandaccessories;GermanversionEN15159-1:2006
【原文标准名称】:釉瓷和搪瓷.加工厂的玻璃层设备.第1部分:设备、部件、器具和附件的质量要求
【标准号】:DINEN15159-1-2006
【标准状态】:作废
【国别】:德国
【发布日期】:2006-10
【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】:验收规范;器具;仪器工程;空白格式;化工设备;覆层厚度;覆层;防腐蚀;缺陷;交货条件;设计;尺寸稳定性;瓷漆的;瓷漆;化学工业的瓷漆;设备;外覆层;格式(纸);检验;制造试验;修补;顺序示度;包装件;工艺工程;质量;质量保证;质量要求;质量检验;航运;规范(验收);钢;表面防护;表面;试验报告;试验;公差(测量);验证;釉层
【英文主题词】:Acceptancespecification;Apparatus;Apparatusengineering;Blankforms;Chemicaltechnologyequipment;Coatingthickness;Coatings;Corrosionprotection;Defects;Deliveryconditions;Design;Dimensionalstability;Enamelled;Enamels;Enamelsforthechemicalindustry;Equipment;Exteriorcoatings;Forms(paper);Inspection;Manufacturer'stest;Mending;Orderindications;Packages;Plant;Processengineering;Quality;Qualityassurance;Qualityrequirements;Qualitytesting;Shipping;Specification(approval);Steels;Surfaceprotection;Surfaces;Testreports;Testing;Tolerances(measurement);Verification;Vitreousenamel
【摘要】:ThisEuropeanStandardspecifiesthequalityrequirementsforapparatus,components,appliancesandaccessoriesofvitreousglass-linedsteel(includingsemi-crystallizedenamelcoatings)andsteelcastusedforprocessplants.Itspecifiesthequalityrequirementsandtheteststobecarriedoutbythemanufactureraswellasthenecessaryactionsforrepairingdefects.ThisEuropeanStandardisalsoapplicabletoglass-linedpumps,pumpcomponentsandfittings.ThisEuropeanstandardisnotapplicabletoglass-linedflangedsteelpipesandflangedsteelfittings.NOTE1Provisionsforglass-linedflangedsteelpipesandflangedsteelfittingsaregiveninDIN2876[1].Thetestmethodsspecifiedcovercheckingtheenamel,dimensionalaccuracyandperformanceofapparatusandcomponents.ThisEuropeanStandardappliestonewapparatusandcomponentsaswellasusedonesthathavetobere-enamelled.ThisEuropeanStandarddoesnotcontainrequirementsregardingthechemicalandphysicalpropertiesofvitreousandporcelainenamels.NOTE2ExamplesoftestreportsaregiveninAnnexA.
【中国标准分类号】:Y93
【国际标准分类号】:25_220_50;71_120_10
【页数】:24P;A4
【正文语种】:德语