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EN ISO 8871-3-2004 非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定

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【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Part3:Determinationofreleased-particlecount(ISO8871-3:2003);GermanversionENISO8871-3:2004,textgermanandenglish
【原文标准名称】:非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定
【标准号】:ENISO8871-3-2004
【标准状态】:现行
【国别】:
【发布日期】:2004-09
【实施或试行日期】:
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:药物;试验;作标记;包装件;漂洗;医学科学;多语种的;规范;橡胶;特性记述;规范(验收);医疗技术学;材料;可视性;识别;硫化橡胶;输注;输注;含水的;药品管理;输血设备;包装手段;储存;检验;药;分类;颗粒物质的测定;注射器械;名称与符号;弹性体;制药技术;胃肠外注入设备;可见的;医疗设备;医学;橡胶制品;制备;注射;药剂学
【英文主题词】:Aqueous;Bloodtransfusionequipment;Characterisations;Classification;Designations;Drugadministration;Drugs;Elastomers;Identification;Infusions;Injectioninstruments;Injections;Inspection;Marking;Materials;Meansofpackaging;Medicalequipment;Medicalsciences;Medicaltechnology;Medicaments;Medicine;Multilingual;Packages;Parenteralinfusionequipment;Particulatemattermeasurement;Pharmaceuticaltechnology;Pharmacy;Preparations;Rinsing;Rubber;Rubberproducts;Specification(approval);Specifications;Storage;Testing;Tests;Transfusions;Visible;Visibleness;Vulcanizedrubber
【摘要】:
【中国标准分类号】:C92
【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】:StandardPracticeforUseofaCeric-CerousSulfateDosimetrySystem
【原文标准名称】:高铈-三价铈硫酸剂量测定系统应用的实施规程
【标准号】:ASTMISO/ASTM51205-2009
【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】:E10.01
【标准类型】:(ISO/ASTM)
【标准水平】:()
【中文主题词】:
【英文主题词】:absorbeddose;ceric-ceroussulfatedosimeter;dose;dosemeasurement;dosimeter;dosimetrysystem;electronbeam;gammaradiation;ionizingradiation;irradiation;photons;radiation;radiationprocessing;reference-standarddosimeter;Xrays;ICS
【摘要】:4.1Theceric-ceroussystemprovidesareliablemeansfordeterminingabsorbeddosetowater.Itisbasedonaprocessofreductionofcericionstocerousionsinacidicaqueoussolutionbyionizingradiation(1,4).NOTE3-Theceric-ceroussystemdescribedinthepracticehasceroussulfateaddedtotheinitialsolutiontoreducetheeffectoforganicimpuritiesandtoallowthepotentiometricmethodofmeasurement.Othersystemsusedfordosimetryincludesolutionsofcericsulfateorcericammoniumsulfateinsulfuricacidwithouttheinitialadditionofceroussulfate.Theseothersystemsarebasedonthesameprocessofreductionofcericionstocerousionsbutarenotincludedinthispractice.4.2Thedosimeterisasolutionofcericsulfateandceroussulfateinsulfuricacidinanappropriatecontainersuchasaflame-sealedglassampoule.Thesolutionindicatesalevelofabsorbeddosebyachange(decrease)inopticalabsorbanceataspecifiedwavelengthintheultravioletregion,orachange(increase)inelectropotential.Acalibratedspectrophotometerisusedtodeterminetheabsorbanceandapotentiometer,withaspeciallydesignedcell,isusedtodeterminetheelectropotentialinmillivolts.4.3Thedosimeterresponsehasanirradiationtemperaturedependencesincetheradiationchemicalyield(G~Ce31!)dependsontemperature.ThedependenceofG~Ce31!isapproximatelyequalto-0.2%perdegreeCelsiusbetween0and62癈(3,5,6).Thisirradiationtemperaturedependencehasaslightdependenceontheinitialcerousionconcentration(see10.6.3).4.4Theabsorbeddosetomaterialsotherthanwaterwhenirradiatedunderequivalentconditionsmaybecalculated.ProceduresformakingsuchcalculationsaregiveninASTMPracticesE666andE668andISO/ASTMGuide51261.NOTE4-Foracomprehensivediscussionofvariousdosimetrymethodsapplicabletotheradiationtypesandenergiesdiscussedinthispractice,seeICRUReports14,34,35,and37.1.1Thispracticecoversthepreparation,testing,andprocedureforusingtheceric-ceroussulfatedosimetrysystemtomeasureabsorbeddoseinwaterwhenexposedtoionizingradiation.Thesystemconsistsofadosimeterandappropriateanalyticalinstrumentation.Forsimplicity,thesystemwillbereferredtoastheceric-ceroussystem.Itisclassifiedasareferencestandarddosimetrysystem(seeISO/ASTMGuide51261).Ceric-cerousdosimetersarealsousedastransfer-standarddosimetersorroutinedosimeters.1.2Thispracticedescribesboththespectrophotometricandthepotentiometricreadoutproceduresfortheceric-ceroussystems.1.3Thispracticeappliesonlyto947;rays,Xrays,andhighenergyelectrons.1.4Thispracticeappliesprovidedthefollowingaresatisfied:1.4.1Theabsorbed-doserangeshallbebetween5102and5104Gy(1).1.4.2Theabsorbed-doserateshallbelessthan106Gy/s(1).1.4.3Forradionuclidegamma-raysources,theinitialphotonenergyshallbegreaterthan0.6MeV.Forbremsstrahlungphotons,theinitialenergyoftheelectronsusedtoproducethebremsstrahlungphotonsshallbeequaltoorgreaterthan2MeV.Forelectronbeams,theinitialelectronenergyshallbegreaterthan8MeV.Note18212;Thelowerenergylimitsareappropriateforacylindricaldosimeterampouleof12-mmdiameter.Correctionsfordosegradientsacrossanampouleofthatdiameterorlessarenotrequiredforphotons,butmayberequiredforelectronbeams(2).Theceric-ceroussystemmaybeusedatlowerenergiesbyemployingthinner(inthebeamdirection)dosimetercontainers(seeICRUReport35).1.4.4Theirradiationtemperatureofthedosimetershallbebetween0and62176;C(3).Note28212;Thetemperaturecoefficientofdosimeterresponseisknownonlyin......
【中国标准分类号】:
【国际标准分类号】:
【页数】:11P.;A4
【正文语种】:英语


基本信息
标准名称:C1玻璃棉毡
中标分类: 建材 >> 建材产品 >> 绝热、吸声、轻质与防火材料
发布日期:
实施日期:1992-06-01
首发日期:
作废日期:
出版日期:
页数:9页
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所属分类: 建材 建材产品 绝热 吸声 轻质与防火材料