DIN VDE 0303-8-1975 绝缘材料电气试验VDE-规范.第9部分:静电性能评估
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来源:标准资料网
【英文标准名称】:VDE-specificationsforelectricaltestsofinsulatingmaterials;evaluationoftheelectrostaticalbehaviour
【原文标准名称】:绝缘材料电气试验VDE-规范.第9部分:静电性能评估
【标准号】:DINVDE0303-8-1975
【标准状态】:现行
【国别】:德国
【发布日期】:1975-04
【实施或试行日期】:1975-04-00
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:绝缘材料;定义;电气工程
【英文主题词】:insulatingmaterials;electricalengineering;definitions
【摘要】:
【中国标准分类号】:K15
【国际标准分类号】:29_040_20
【页数】:10P;A4
【正文语种】:德语
【英文标准名称】:StandardGuideforApplicationofContinuousQualityVerificationtoPharmaceuticalandBiopharmaceuticalManufacturing
【原文标准名称】:药品和生物药品生产中持续质量验证的标准指南
【标准号】:ASTME2537-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:E55.03
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:continuousimprovement;continuousqualitymonitoring;continuousqualityverification;processcapabilityanalysis;processcontrolstrategy;processunderstanding;real-timerelease
【摘要】:Applicationoftheapproachdescribedwithinthisstandardguideappliesscience-basedconceptsandprinciplesintroducedintheFDAinitiativePharmaceuticalcGMPsforthe21stCentury.Thisguidesupports,andisconsistentwith,elementsfromICHQ8andICHQ9.AccordingtoFDAGuidanceforIndustry,PAT,x201C;Withrealtimequalityassurance,thedesiredqualityattributesareensuredthroughcontinuousassessmentduringmanufacture.Datafromproductionbatchescanservetovalidatetheprocessandreflectthetotalsystemdesignconcept,essentiallysupportingvalidationwitheachmanufacturingbatch.x201D;Inotherwords,theaccumulatedproductandprocessunderstandingusedtoidentifytheCriticalQualityAttributes(CQAs),togetherwiththeknowledgethattherisk-basedmonitoringandcontrolstrategywillenablecontroloftheCQAs,shouldprovidetheconfidenceneededtoshowvalidationwitheachbatch.Thisisasopposedtoaconventionaldiscreteprocessvalidationapproach.1.1ThisguidedescribesContinuousQualityVerification(CQV)asanapproachtoprocessvalidationwheremanufacturingprocess(orsupportingutilitysystem)performanceiscontinuouslymonitored,evaluatedandadjusted(asnecessary).Itisascience-basedapproachtoverifythataprocessiscapableandwillconsistentlyproduceproductmeetingitspredeterminedcriticalqualityattributes.CQVissimilarlydescribedasContinuousQualityAssurance(U.S.FDA)andContinuousProcessVerification(ICHQ8).1.2Pharmaceuticalandbiopharmaceuticalproductmanufacturingcompaniesarerequiredtoprovideassurancethattheprocessesusedtomanufactureregulatedproductsresultinproductswiththespecifiedcriticalqualityattributesofstrengthidentityandpurityassociatedwiththeproductsafety,andefficacy.Processvalidationisawayinwhichcompaniesprovidethatassurance.1.3Withtheknowledgeobtainedduringtheproductlifecycle,aframeworkforcontinuousqualityimprovementwillbeestablishedwherethefollowingmaybepossible:(1)riskmitigated,(2)processvariabilityreduced,(3)processcapabilityenhanced,(4)processdesignspacedefinedorenhanced,andultimately(5)productqualityimproved.Thiscanenableanumberofbenefitsthataddressbothcomplianceandoperationalgoals(forexample,realtimerelease,continuousprocessimprovement).1.4Theprinciplesinthisguidemaybeappliedtodrugproductoractivepharmaceuticalingredient/drugsubstancepharmaceuticalandbiopharmaceuticalbatchorcontinuousmanufacturingprocessesorsupportingutilitysystems(forexample,TOCforPurifiedWaterandWaterforInjectionsystems,andsoforth).1.5Theprinciplesinthisguidemaybeappliedduringthedevelopmentandmanufacturingofanewprocessorproductorfortheimprovementand/orredesignofanexistingprocess.1.6Continuousqualityverificationmaybeappliedtomanufacturingprocessesthatusemonitoringsystemsthatprovidefrequentandobjectivemeasurementofprocessdata.Theseprocessesmayormaynotemployin-,on-,orat-lineanalyzers/controllersthatmonitor,measure,analyze,andcontroltheprocessperformance.Theassociatedprocessesmayormaynothaveadesignspace.1.7ThisguidemaybeusedindependentlyorinconjunctionwithotherproposedE55standardstobepublishedbyASTMInternational.
【中国标准分类号】:C00
【国际标准分类号】:11_120_01
【页数】:4P.;A4
【正文语种】:英语
【英文标准名称】:Pliers(longnose,longreach)
【原文标准名称】:尖嘴长臂钳
【标准号】:ASMEB107.13M-1996
【标准状态】:作废
【国别】:美国
【发布日期】:1996
【实施或试行日期】:
【发布单位】:美国机械工程师协会(ASME)
【起草单位】:ASME
【标准类型】:()
【标准水平】:()
【中文主题词】:切削工具;尺寸;试验;手柄轴;手工工具;规范(验收);材料规范;老虎钳
【英文主题词】:specification(approval);pliers;cuttingtools;dimensions;handleshafts;materialsspecification;handtools;testing
【摘要】:
【中国标准分类号】:J47
【国际标准分类号】:25_140_30
【页数】:25P;A4
【正文语种】:英语
