DIN EN 868-6-2009 最终灭菌医疗器械的包装.第6部分:低温灭菌处理用纸.试验方法和要求.英文版本DINEN868-6-2009-09
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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part6:Paperforlowtemperaturesterilizationprocesses-Requirementsandtestmethods;EnglishversionofDINEN868-6:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第6部分:低温灭菌处理用纸.试验方法和要求.英文版本DINEN868-6-2009-09
【标准号】:DINEN868-6-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【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】:可处置的;一次性使用设备;环氧乙烷;卫生学;检验;低温;作标记;医疗器械;医疗器材;医学科学;医疗技术学;包装件;包装材料;包装试验;纸;孔径;产品;安全性;安全性要求;规范(验收);绝育;辐射灭菌;灭菌;消毒物品;灭菌器;试验;运输包装;证实;拒水性
【英文主题词】:Disposable;Equipmentforsingleuse;Ethyleneoxide;Hygiene;Inspection;Lowtemperatures;Marking;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Poresizes;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Testing;Transportpacking;Validation;Waterrepellency
【摘要】:ThispartofEN868providestestmethodsandvaluesforpaperusedinthemanufactureofpreformedsterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.3canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.PaperspecifiedinthispartoftheseriesEN868isintendedforuseinpartorcompletemanufactureofpouchesandformandfillpacksandliddingmaterialforpacks.NOTE2ThepaperspecifiedinthispartoftheseriesEN868issuitableforthemanufactureofsterilebarriersystemstobeusedinethyleneoxide,irradiationorlowtemperaturesteamformaldehydesterilizationprocessesandtoproducecoatedpaperaccordingtoEN868-7.NOTE3PaperaccordingtoEN868-3canalsobeusedforthesesterilizationprocesses.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE4Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilters,indicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:20P.;A4
【正文语种】:英语
【英文标准名称】:StandardTestMethodforPrimaryCalibrationofAcousticEmissionSensors
【原文标准名称】:声发射传感器一次校准的标准试验方法
【标准号】:ASTME1106-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:E07.04
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:声学设备;声学;校准;发射;无损检验;传感器;试验设备;测试
【英文主题词】:absolutecalibration;acousticemissionsensor;breakingcapillary;capacitivetransducer;nondestructivetesting;surfacewave;transferstandard
【摘要】:TransferStandards8212;OnepurposeofthistestmethodisforthedirectcalibrationofdisplacementtransducersforuseassecondarystandardsforthecalibrationofAEsensorsforuseinnondestructiveevaluation.Forthispurpose,thetransferstandardshouldbehighfidelityandverywellbehavedandunderstood.Ifthiscanbeestablished,thestatedaccuracyshouldapplyoverthefullfrequencyrangeupto1MHz.Note18212;Thestatedaccuracyappliesonlyifthetransferstandardreturnstoquiescence,followingthetransientinput,beforeanywavereflectedfromtheboundaryofthecalibrationblockreturnstothetransferstandard(8764;100x03BC;s).Forlowfrequencieswithperiodsontheorderofthetimewindow,thisconditionisproblematicaltoprove.ApplicationsSensors8212;ThistestmethodmayalsobeusedforthecalibrationofAEsensorsforuseinnondestructiveevaluation.Someofthesesensorsarelesswellbehavedthandevicessuitableforatransferstandard.Thestatedaccuracyforsuchdevicesappliesintherangeof100kHzto1MHzandwithlessaccuracybelow100kHz.1.1Thistestmethodcoverstherequirementsfortheabsolutecalibrationofacousticemission(AE)sensors.Thecalibrationyieldsthefrequencyresponseofatransducertowaves,atasurface,ofthetypenormallyencounteredinacousticemissionwork.Thetransducervoltageresponseisdeterminedatdiscretefrequencyintervalsofapproximately10kHzupto1MHz.Theinputisagivenwell-establisheddynamicdisplacementnormaltothemountingsurface.Theunitsofthecalibrationareoutputvoltageperunitmechanicalinput(displacement,velocity,oracceleration).Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:N65
【国际标准分类号】:17_140_01
【页数】:11P.;A4
【正文语种】:
【英文标准名称】:Respiratoryprotectivedevices-Self-containedopen-circuitcompressedairbreathingapparatuswithhalfmaskdesignedtoincludeapositivepressurelunggoverneddemandvalveforescapepurposesonly
【原文标准名称】:呼吸保护装置.逃生专用包含由需求阀控制的正压呼吸器的带半截面罩的自持式开路压缩气体呼吸机
【标准号】:BSEN14529-2005
【标准状态】:现行
【国别】:英国
【发布日期】:2006-05-31
【实施或试行日期】:2006-05-31
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;空气存储器;呼吸装置;呼吸管;压缩空气;压缩空气呼吸装置;压缩空气设备;制造日期;逃生;呼气阀;面罩;半截面罩;吸气阀;检验;使用说明书;绝缘电阻;肺通气器;作标记;材料;最低要求;公称使用范围;职业安全;性能要求;压力过载;产品信息;防护服装;规格试验;呼吸器;安全装置;安全工程;自备救护箱;规范(验收);温度稳定性;测试;用户信息
【英文主题词】:Accidentprevention;Airreceivers;Breathingapparatus;Breathingtubes;Compressedair;Compressedairbreathings;Compressed-airdevices;Dataofthemanufacturer;Escape;Exhalingvalves;Facepieces;Halfmasks;Inhalingvolve;Inspection;Instructionsforuse;Insulatingresistance;Lungventilators;Marking;Materials;Minimumrequirements;Nominalrangeofuse;Occupationalsafety;Performancerequirements;Pressureoverload;Productinformations;Protectiveclothing;Ratingtests;Respirators;Safetydevices;Safetyengineering;Selfcontainingboxes;Specification(approval);Temperaturestability;Testing;Userinformation
【摘要】:ThisEuropeanStandardspecifiesminimumrequirementsforself-containedopen-circuitcompressedairbreathingapparatuswithhalfmaskdesignedtoincludeapositivepressurelunggoverneddemandvalveforescapepurposesonly.Suchequipmentisintendedforuseinworksituationswheretheriskonoverpressurisationofthepressurevesselswiththeirvalvesduetohotenvironmentalconditionsislow.ThisEuropeanStandarddoesnotapplytoapparatusforworkandrescueortodivingapparatus.Laboratoryandpracticalperformancetestsareincludedfortheassessmentofcompliancewiththerequirements.
【中国标准分类号】:C73
【国际标准分类号】:13_340_30
【页数】:32P.;A4
【正文语种】:英语