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DIN EN 15546-1-2008 卫生保健设施中液体和气体用小型钻孔连接器.第1部分:通用要求

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【英文标准名称】:Smallboreconnectorsforliquidsandgasesinhealthcareapplications-Part1:Generalrequirements;GermanversionEN15546-1:2008
【原文标准名称】:卫生保健设施中液体和气体用小型钻孔连接器.第1部分:通用要求
【标准号】:DINEN15546-1-2008
【标准状态】:作废
【国别】:德国
【发布日期】:2008-08
【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;可清除干净特性;清洁处理;连接件;定义;直径;消毒;气体;液体;材料;介质;医疗设备;医用气体;医疗技术学;非互换性;危险分析;小;规范(验收)
【英文主题词】:Accessories;Cleanability;Cleaning;Connectingpieces;Definition;Definitions;Diameter;Disinfections;Gases;Liquids;Materials;Media;Medicalequipment;Medicalgases;Medicaltechnology;Non-interchangeability;Riskanalysis;Small;Specification(approval)
【摘要】:ThispartoftheseriesofEuropeanStandardsspecifiesgeneralrequirementsforsmallboreconnectorsusedinspecificmedicalapplicationstoconveyliquidsorgasestoorfromapatientorviaintermediatesystems.Itisintendedtobeareferencedocumentthatcanbeusedasatooltominimisetheriskofmisconnectionsofsmallboreconnectorsbetweendifferentmedicalapplications.Itprovidesaframeworktoassessnon-interchangeabilityofsmallboreconnectorsbasedontheirinherentdesignanddimensions.Itdoesnotspecifyrequirementsforthemedicaldevicesandaccessoriesonwhichtheseconnectorsareprovided.SuchrequirementsaregiveninparticularInternationalorEuropeanStandardsforspecificmedicaldevicesandaccessories.NOTEIItisintendedthatnewdesignsofsmallboreconnectorsshouldbeincludedinthisseriesofStandardsaftertheyhavebeenassessedaccordingtotheproceduregiveninClause6.NOTE2ManufacturersareencouragedtoincorporatethesmallboreconnectorsspecifiedinthisseriesofStandardsintomedicaldevicesorsystems,eveniftheyarenotcurrentlyrequiredbytheparticulardevicestandards.Itisexpectedthatwhentheparticulardevicestandardsarerevised,requirementsforsmallboreconnectorsasspecifiedintheseriesofStandardswillbeincluded.NOTE3ManufacturersandusersareencouragedtoreporttheirexperiencewiththesmallboreconnectorsspecifiedinthisseriesofStandardstothetechnicalcommitteeortaskforceinchargeoftheelaborationofthepresentseriesofStandards,toconsiderthisfeedbackduringtherevisionoftherelevantpartofthisseriesofStandards.
【中国标准分类号】:C30
【国际标准分类号】:11_040_10
【页数】:31P.;A4
【正文语种】:德语


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【英文标准名称】:Feetwiththreadedshankforjigsandfixtures
【原文标准名称】:工装和夹具用螺纹体支脚
【标准号】:DIN6320-2002
【标准状态】:现行
【国别】:德国
【发布日期】:2002-10
【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】:钻模;夹紧和固定装置的设计;尺寸;材料;螺纹管端;脚
【英文主题词】:threadedtubeends;jigs;dimensions;jigandfixturedesign;materials;foot
【摘要】:Thedocumentspecifiesthedimensionsoffeetwiththreadedshank,tobeusedincombinationwithotherclampingelementsforworkpiecesofjigsandfixturesonmachinetooltables,palletsandclampingdevicesofworkpiecesortools.
【中国标准分类号】:J45
【国际标准分类号】:25_060_10
【页数】:3P;A4
【正文语种】:德语


【英文标准名称】:StandardTestMethodforNondestructiveDetectionofLeaksinPackagesbyVacuumDecayMethod
【原文标准名称】:用真空衰变法的包装紧密性无损检验的标准试验方法
【标准号】:ASTMF2338-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:absolutepressuretransducer;barrierperformance;block;criteriaparameters;differentialpressuretransducer;flexiblepackaging;foodpackages;gaugepressuretransducer;holeleaks;holes;leaks;liquidleaks;mask;medicalpackages;non-destructive
【摘要】:Leaksinmedicaldevice,pharmaceutical,andfoodpackagesmayresultintheingressofunwantedgases(mostcommonlyoxygen),harmfulmicrobiological,orparticulatecontaminants.Packageleaksmayappearasimperfectionsinthepackagecomponentsthemselvesoratthesealjuncturebetweenmatedcomponents.Theabilitytodetectleaksisnecessarytoensureconsistencyandintegrityofpackages.Afterinitialset-upandcalibration,individualtestoperationmaybesemi-automatic,automatic,ormanual.Thetestmethodpermitsnon-destructivedetectionofleaksnotvisiblydetectable.Thetestmethoddoesnotrequiretheintroductionofanyextraneousmaterialsorsubstances,suchasdyesorgases.However,itisimportanttophysicallymaskorblockoffanypackageporousbarriersurfaceduringthetesttopreventrapidlossofchambervacuumresultingprimarilyfromgasmigrationthroughtheporoussurface.Leakdetectionisbasedsolelyontheabilitytodetectthechangeinpressureinsidethetestchamberresultingfromgasorvaporegressfromapackagechallengedwithvacuum.Thistestisausefulresearchtoolforoptimizingpackagesealingparametersandforcomparativelyevaluatingvariouspackagesandmaterials.Thistestmethodisalsoapplicabletoproductionsettingsasitisrapid,non-invasive,andnon-destructive,makingitusefulforeither100%on-linetestingortoperformtestsonastatisticalsamplingfromtheproductionoperation.Leaktestresultsthatexceedthepermissiblelimitsforthevacuumdecaytestareindicatedbyaudibleorvisualsignalresponses,orboth.1.1TestPackages8212;Packagesthatcanbenondestructivelyevaluatedbythistestmethodinclude:1.1.1Rigidandsemi-rigidnon-liddedtrays.1.1.2Traysorcupssealedwithporousbarrierliddingmaterial.1.1.3Rigid,nonporouspackages.1.1.4Flexible,nonporouspackages.1.2LeaksDetected8212;Thistestmethoddetectspackageleaksbymeasuringtheriseinpressure(vacuumloss)inanenclosedevacuatedtestchambercontainingthetestpackage.Vacuumlossresultsfromleakageoftestpackageheadspacegasesand/orvolatilizationoftestpackageliquidcontentslocatedinorneartheleak.Whentestingforleaksthatmaybepartiallyorcompletelypluggedwiththepackagex2019;sliquidcontents,thetestchamberisevacuatedtoapressurebelowtheliquidx2019;svaporizationpressure.Allmethodsrequireatestchambertocontainthetestpackageandaleakdetectionsystemdesignedwithoneormorepressuretransducers.Testmethodsensitivitiescitedbelowweredeterminedusingspecificproduct-packagesystemsselectedfortheprecisionandbiasstudiessummarizedinTable1.Table1alsolistsotherexamplesofrelevantproduct-packagesystemsthatcanbetestedforleakagebyvacuumdecay.1.2.1TraysorCups(Non-lidded)(AirLeakage)8212;Holeorcrackdefectsinthewallofthetray/cupofatleast50x03BC;mindiametercanbedetected.NonliddedtraysweretestedataTargetVacuumofx2013;4x00B7;E4Pa(x2013;400mbar).1.2.2TraysSealedwithPorousBarrierLiddingMaterial(HeadspaceGasLeakage)8212;Holeorcrackdefectsinthewallofthetray/cupofatleast100x03BC;mindiametercanbedetected.Channeldefectsinthesealarea(madeusingwiresof125