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ISO 13408-1-2008 医疗保健产品的无菌加工.第1部分:一般要求

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【英文标准名称】:Asepticprocessingofhealthcareproducts-Part1:Generalrequirements
【原文标准名称】:医疗保健产品的无菌加工.第1部分:一般要求
【标准号】:ISO13408-1-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-06
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:无菌的;检验;定义;医疗卫生事业;制造;医疗技术学;生产;质量;质量保证;规范(验收);无菌
【英文主题词】:Aseptic;Checks;Definitions;Healthservices;Manufacturing;Medicaltechnology;Production;Quality;Qualityassurance;Specification(approval);Sterility
【摘要】:1.1ThispartofISO13408specifiesthegeneralrequirementsfor,andoffersguidanceon,processes,programmesandproceduresfordevelopment,validationandroutinecontrolofthemanufacturingprocessforaseptically-processedhealthcareproducts.1.2ThispartofISO13408includesrequirementsandguidancerelativetotheoveralltopicofasepticprocessing.Specificrequirementsandguidanceonvariousspecializedprocessesandmethodsrelatedtofiltration,lyophilization,clean-inplace(CIP)technologies,sterilizationinplace(SIP)andisolatorsystemsaregiveninotherpartsofISO13408.NOTEThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orpharmacopoeialrequirementsthatpertaininparticularnationalorregionaljurisdictions.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01
【页数】:54P.;A4
【正文语种】:英语


【英文标准名称】:StandardTestMethodforMicroscopicalDeterminationofParametersoftheAir-VoidSysteminHardenedConcrete
【原文标准名称】:硬化混凝土中空气孔隙系统参数的显微测定用标准试验方法
【标准号】:ASTMC457/C457M-2010
【标准状态】:现行
【国别】:
【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】:C09.65
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:空气含量;硬化混凝土中空气孔隙参数;要求的制备区域表面;空隙的平均弦长;空气孔隙参数的测定;产生的空隙;埋陷空隙;硬化混凝土搭叠的研磨粒;指标点;研磨;要求的截线长度;线性截线法;显微镜的;要求的点数;湿黏土-空气比;改良湿黏土-空气比;湿黏土含量;点计数法;显微镜分析的试样制备;空间系数;专用表面;孔隙率;水孔隙;空气含量-混凝土;空气孔隙;硬化水泥;显微镜检验-混凝土;改良点计算法;岩石分析;气孔结果;表面分析-混凝土
【英文主题词】:aircontent;airvoidparametersofhardenedconcrete;area-preparedsurfacerequired;averagechord-lengthofvoids;determinationofair-voidparameters;entrainedvoid;entrappedvoid;gritsforlappinghardenedconcrete;indexpoint;lapping;lengthoftraverserequired;linear-traversemethod;microscopical;numberofpointsrequired;paste-airratio;paste-airratiomodification;pastecontent;point-countmethod(modified);samplepreparationformicroscopicalanalysis;spacingfactor;specificsurface;voidfrequency;watervoid;Aircontent--concrete;Airvoids;Hardenedconcrete;Lineartraverse(Rosiwal)method;Microscopicexamination--concrete;Modifiedpoint-countmethod;Petrographicanalysis;Porestructure;Spacingfactor;Surfaceanalysis--concrete
【摘要】:Theparametersoftheair-voidsystemofhardenedconcretedeterminedbytheproceduresdescribedinthistestmethodarerelatedtothesusceptibilityofthecementpasteportionoftheconcretetodamagebyfreezingandthawing.Hence,thistestmethodcanbeusedtodevelopdatatoestimatethelikelihoodofdamageduetocyclicfreezingandthawingortoexplainwhyithasoccurred.Thetestmethodcanalsobeusedasanadjuncttothedevelopmentofproductsorproceduresintendedtoenhancetheresistanceofconcretetocyclicfreezingandthawing(1).Valuesforparametersoftheair-voidsystemcanbeobtainedbyeitheroftheproceduresdescribedinthistestmethod.Noprovisionismadefordistinguishingamongentrappedairvoids,entrainedairvoids,andwatervoids.Anysuchdistinctionisarbitrary,becausethevarioustypesofvoidsintergradeinsize,shape,andothercharacteristics.Reportsthatdomakesuchadistinctiontypicallydefineentrappedairvoidsasbeinglargerthan1mminatleastonedimensionbeingirregularinshape,orboth.Thehoney-combingthatisaconsequenceofthefailuretocompacttheconcreteproperlyisonetypeofentrappedairvoid(9,10).Watervoidsarecavitiesthatwerefilledwithwateratthetimeofsettingoftheconcrete.Theyaresignificantonlyinmixturesthatcontainedexcessivemixingwaterorinwhichpronouncedbleedingandsettlementoccurred.Theyaremostcommonbeneathhorizontalreinforcingbars,piecesofcoarseaggregateandaschannelwaysalongtheirsides.Theyoccuralsoimmediatelybelowsurfacesthatwerecompactedbyfinishingoperationsbeforethecompletionofbleeding.Applicationofthepaste-airratioprocedureisnecessarywhentheconcreteincludeslargenominalmaximumsizeaggregate,suchas50mm[2in.]ormore.Preparedsectionsofsuchconcreteshouldincludeamaximumofthemortarfraction,soastoincreasethenumberofcountsonairvoidsortraverseacrossthem.Theratioofthevolumeofaggregatetothevolumeofpasteintheoriginalmixmustbeaccuratelyknownorestimatedtopermitthecalculationoftheair-voidsystemsparametersfromthemicroscopicallydeterminedpaste-airratio.Note18212;Theair-voidcontentdeterminedinaccordancewiththistestmethodusuallyagreescloselywiththevaluedeterminedonthefreshconcreteinaccordancewithTestMethodsC138/C138M,C173/C173M,orC231(11).However,significantdifferencesmaybeobservedifthesampleoffreshconcreteisconsolidatedtoadifferentdegreethanthesamplelaterexaminedmicroscopically.Forconcretewitharelativelyhighaircontent(usuallyover7.5%),thevaluedeterminedmicroscopicallymaybehigherbyoneormorepercentagepointsthanthatdeterminedbyTestMethodC231.1.1Thistestmethoddescribesproceduresformicroscopicaldeterminationsoftheaircontentofhardenedconcreteandofthespecificsurface,voidfrequency,spacingfactor,andpaste-airratiooftheair-voidsysteminhardenedconcrete(1).Twoproceduresaredescribed:1.1.1ProcedureA,thelinear-traversemethod(2,3).1.1.2ProcedureB,t......
【中国标准分类号】:
【国际标准分类号】:
【页数】:15P.;A4
【正文语种】:


基本信息
标准名称:粉末渗金属
中标分类: 机械 >> 加工工艺 >> 热处理
替代情况:被JB/T 8418-2008代替
发布部门:中华人民共和国机械工业部
发布日期:1996-09-03
实施日期:1997-07-01
首发日期:1900-01-01
作废日期:2008-11-01
提出单位:全国热处理标准化技术委员会
归口单位:全国热处理标准化技术委员会
起草单位:机械工业部武汉材料保护研究所
起草人:杨裕雄
出版社:机械工业出版社
出版日期:1997-07-01
页数:7 页
批文号:机械科[1996]685号
适用范围

本标准规定了铁基及非铁基合金工件在粉末介质中渗铬、渗铝和渗锌的基体材料、设备、渗剂、渗金属工艺及后处理、渗层质量检验和安全技术的基本要求。
本标准适用于要求表面耐磨、抗蚀、抗氧化的铁基及非铁基合金成品或待抛光的半成品工件,不适用于待磨削加工的工件。

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所属分类: 机械 加工工艺 热处理