BS EN ISO 8536-3-2009 医用输液设备.第3部分:输液瓶的铝制瓶盖(ISO8536-3-2009)
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【英文标准名称】:Infusionequipmentformedicaluse-Part3:Aluminiumcapsforinfusionbottles(ISO8536-3:2009)
【原文标准名称】:医用输液设备.第3部分:输液瓶的铝制瓶盖(ISO8536-3-2009)
【标准号】:BSENISO8536-3-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:铝;帽(闭塞物);名称与符号;尺寸规格;输注用瓶;滚花帽;医疗设备;胃肠外注入设备;大小测量;规范(验收);公差(测量)
【英文主题词】:Aluminium;Caps(closures);Designations;Dimensions;Infusionbottles;Knurledcaps;Medicalequipment;Parenteralinfusionequipment;Sizemeasurement;Specification(approval);Tolerances(measurement)
【摘要】:ThispartofISO8536specifiesaluminiumcapsforinfusionglassbottleswhichareinaccordancewithISO8536-1.
【中国标准分类号】:C31
【国际标准分类号】:11_040_20
【页数】:12P.;A4
【正文语种】:英语
【英文标准名称】:Indexablehardmetal(carbide)insertswithroundedcorners,withcylindricalfixinghole.Dimensions.
【原文标准名称】:带固定孔和圆角的可转位硬质合金(碳化物合金)镶嵌刀片.尺寸
【标准号】:NFE66-315-1997
【标准状态】:作废
【国别】:法国
【发布日期】:1997-11-01
【实施或试行日期】:1997-11-05
【发布单位】:法国标准化协会(FR-AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Boltholes;Carbidetools;Cornerradii;Cuttingtools;Designations;Dimensions;Indexableinserts;Inserts(cuttingtools);Marking;Metals;Tools;Wells
【摘要】:
【中国标准分类号】:J41
【国际标准分类号】:25_100_01
【页数】:17P.;A4
【正文语种】:其他
【英文标准名称】:StandardGuideforMechanicalandFunctionalCharacterizationofNucleusDevices
【原文标准名称】:核装置的机械和功能特征表示的标准指南
【标准号】:ASTMF2789-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:F04.25
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:dynamictests;nucleusdevice;spinalimplants;statictests
【摘要】:Nucleusdevicesaregenerallydesignedtoaugmentthemechanicalfunctionofnativedegeneratednucleusmaterialortoreplacetissuethathasbeenremovedduringasurgicalprocedure.Thisguideoutlinesmethodsforevaluatingmanydifferenttypesofdevices.Comparisonsbetweendevicesmustbemadecautiouslyandwithcarefulanalysis,takingintoaccounttheeffectsthatdesignandfunctionaldifferencescanhaveonthetestingconfigurationsandoverallperformance,andthepossibilitythatmechanicalfailuremaynotberelatedtoclinicalfailureandinversely,thatmechanicalsuccessmaynotberelatedtoclinicalsuccess.Thesetestsareconductedinvitrotoallowforanalysisofthemechanicalperformanceofthenucleusdeviceunderspecifictestingmodalities.Theloadsappliedmaydifferfromthecomplexloadingseeninvivo,andthereforetheresultsfromthesetestsmaynotdirectlypredictinvivoperformance.Thesetestsareusedtoquantifythestaticanddynamicpropertiesandperformanceofdifferentimplantdesigns.Themechanicaltestsareconductedinvitrousingsimplifiedloadsandmoments.Fatiguetestinginasimulatedbodyfluidorsalinemayhavefretting,aging,corroding,orlubricatingeffectsonthedeviceandtherebyaffecttherelativeperformanceoftesteddevices.Hence,thetestenvironmentandtheeffectofthatenvironment,whetherasimulatedbodyfluid,normalsalinebath(9gNaClper1000mLH2O),ordry,isanimportantcharacteristicofthetestandmustbereportedaccurately.Dynamictestingmethodsshouldbedesignedtoanswerthefollowingquestions,includingbutnotlimitedto:Doesthedevicestillfunctionasintendedaftercycling?Doesitretainadequateperformancecharacteristics(forexample,mechanicalandkinematicpropertiessuchasROM)?Didthedevicewearordegrade?Ifthereisevidenceofwearordegradationofthedevice,itshouldbeidentifiedandquantifiedwithreasonablemethodsgenerallyavailable.Theusershalldistinguishbetweenparticulatesgeneratedbythedeviceandparticulatesgeneratedbythetestmodelandfixturesiftechnicallyfeasible.1.1Thisguidedescribesvariousformsofnucleusreplacementandnucleusaugmentationdevices.Itfurtheroutlinesthetypesoftestingthatarerecommendedinevaluatingtheperformanceofthesedevices.1.2Biocompatibilityofthematerialsusedinanucleusreplacementdeviceisnotaddressedinthisguide.However,usersshouldinvestigatethebiocompatibilityoftheirdeviceseparately(seeX1.1).1.3Whileitisunderstoodthatexpulsionandendplatefracturesrepresentdocumentedclinicalfailures,thisguidedoesnotspecificallyaddressthem,althoughsomeofthefactorsthatrelatetoexpulsionhavebeenincluded(seeX1.3).1.4Multipletestsaredescribedinthisguide;however,theuserneednotusethemall.Itistheresponsibilityoftheuserofthisguidetodeterminewhichtestsareappropriateforthedevicesbeingtestedandtheirpotentialapplication.Sometestsmaynotbeapplicableforalltypesofdevices.Moreover,somenucleusdevicesmaynotbestableinalltestconfigurations.However,thisdoesnotnecessarilymeanthatthetestmethodsdescribedareunsuitable.1.5Thescienceofnucleusdevicedesignisstillveryyoungandincludestechnologythatischangingmorequicklythanthisguidecanbemodified.Therefore,theusermustcarefullyconsidertheapplicabilityofthisguidetotheuserx2019;sparticulardevice;theguidemaynotbeappropriateforeverydevice.Forexample,atthetimeofpublication,thisguidedoesnotaddressthenucleusreplacementandnucleusaugmentationdevi......
【中国标准分类号】:F60
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:英语