BS EN ISO 10993-9-2009 医疗器械的生物学评估.潜在降解产物的鉴别和定量框架
时间:2024-05-05 17:12:34 来源: 标准资料网 作者：标准资料网 阅读：8160
【英文标准名称】:Biologicalevaluationofmedicaldevices-Frameworkforidentificationandquantificationofpotentialdegradationproducts
【原文标准名称】:医疗器械的生物学评估.潜在降解产物的鉴别和定量框架
【标准号】:BSENISO10993-9-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-06-30
【实施或试行日期】:2010-06-30
【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】:生物测定;生化制品;生物降解力;生物学;分解产物;定义;降解;变坏;测定;评估;鉴别;医疗器械;医疗产品;医疗技术学;量化
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:ThispartofISO10993providesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.InformationobtainedfromthesestudiescanbeusedinthebiologicalevaluationdescribedintheISO10993series.ThispartofISO10993considersbothnon-resorbableandresorbablematerials.ThispartofISO10993isnotapplicableto:a)evaluationofdegradationwhichoccursbypurelymechanicalprocesses;methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;b)leachablecomponentswhicharenotdegradationproducts;c)medicaldevicesorcomponentsthatdonotcontactthepatient'sbodydirectlyorindirectly.NOTE2ThispartofISO10993canbeappliedtothedegradationofmaterialsusedinanykindofproductthatfallswithinthedefinitionof“medicaldevice”inISO10993-1,evenifsuchproductsaresubjecttodifferentregulationsfromthoseapplyingtomedicaldevices,e.g.thescaffoldinatissueengineeredmedicalproduct,oracarriermatrixtodeliverdrugsorbiologics.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:20P.;A4
【正文语种】:英语
【英文标准名称】:StandardSpecificationforCastings,Austenitic-Ferritic(Duplex)StainlessSteel,forPressure-ContainingParts
【原文标准名称】:压力控制元件用奥氏体-铁素体(双重)不锈钢铸件的标准规范
【标准号】:ASTMA995-1998
【标准状态】:作废
【国别】:美国
【发布日期】:1998
【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】:奥氏体-铁素体;双重不锈钢;钢铸件;压力控制
【英文主题词】:stainlesssteels;steels;castings;qualityrequirements;duplex;alloysteels
【摘要】:
【中国标准分类号】:J31
【国际标准分类号】:77_140_80
【页数】:3P;A4
【正文语种】:英语
【英文标准名称】:StandardTestMethodforMeasuringReactionRatesandFast-NeutronFluencesbyRadioactivationofSulfur-32
【原文标准名称】:用硫-32的放射性测量快速中子流量密度和反应速率的测试方法
【标准号】:ASTME265-2007e1
【标准状态】:现行
【国别】:美国
【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】:E10.07
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:activationanalysis;betacounting;fast-neutronfluences;neutronmeasurement;reactionrates;sulfur;Activationreactions;Betacounting;Fastneutronflux/fluence;Neutronactivationreactions;Neutronflux/fluence;Radioactivation--fastneutron
【摘要】:RefertoGuidesE720andE844fortheselection,irradiation,andqualitycontrolofneutrondosimeters.RefertoPracticeE261forageneraldiscussionofthedeterminationoffast-neutronfluenceandfluenceratewiththresholddetectors.Theactivationreactionproduces32P,whichdecaysbytheemissionofasinglebetaparticlein100%ofthedecays,andwhichemitsnogammarays.Thehalflifeof32Pis14.262(14)days(1)andthemaximumbetaenergyis1710keV(2).Elementalsulfurisreadilyavailableinpureformandanytracecontaminantspresentdonotproducesignificantamountsofradioactivity.Naturalsulfur,however,iscomposedof32S(95.02%(9)),34S(4.21%(8))(1),andtraceamountsofothersulfurisotopes.Thepresenceoftheseotherisotopesleadstoseveralcompetingreactionsthatcaninterferewiththecountingofthe1710-keVbetaparticle.Thisinterferencecanusuallybeeliminatedbytheuseofappropriatetechniques,asdiscussedinSection8.1.1Thistestmethoddescribesproceduresformeasuringreactionratesandfast-neutronfluencesbytheactivationreaction32S(n,p)32P.1.2Thisactivationreactionisusefulformeasuringneutronswithenergiesaboveapproximately3MeV.1.3Withsuitabletechniques,fission-neutronfluencesfromabout5x00D7;108to1016n/cm2canbemeasured.1.4Detailedproceduresforotherfast-neutrondetectorsaredescribedinPracticeE261.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyproblems,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:F46
【国际标准分类号】:27_120_30
【页数】:6P.;A4
【正文语种】:英语