MIL-H-24591B
作者:标准资料网 时间:2024-05-18 02:59:06 浏览:8123
来源:标准资料网
MIL-H-24591B, MILITARY SPECIFICATION: HOISTS, CHAIN, PNEUMATIC, LOW HEADROOM, TROLLEY TYPE (28 FEB 1994)., This specification covers pneumatic, trolley type chain hoists with traverse drive, having extreme low headroom and zero load eccentricity. Hoists include a lifting unit, a traversing unit, and a pendant unit.
【英文标准名称】:Instructionsforuseforinvitrodiagnosticinstrumentsforself-testing
【原文标准名称】:自我测试用体外诊断仪器的使用说明书
【标准号】:BSEN592-2002
【标准状态】:作废
【国别】:英国
【发布日期】:2002-05-03
【实施或试行日期】:2002-05-03
【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】:规范(验收);规范(验收);诊断设备;定义;定义;利用;诊断(医学);诊断系统;实验室条件下诊断;手册;医学科学;含量;在实验室条件下;使用说明;用户信息;应用;多语种的;图形符号;医疗设备;家用;文献工作
【英文主题词】:Contents;Definitions;Diagnosis(medical);Diagnosticequipment;Diagnosticsystems;Graphicsymbols;Handbooks;Householduse;Invitro;Instructionsforuse;In-vitrodiagnostic;Medicalequipment;Medicalsciences;Operationalinstructions;Specification(approval);Use;Userinformation;Utilization
【摘要】:ThisEuropeanStandardspecifiestherequirementsforthecontentsofinstructionsforuseforinvitrodiagnosticinstrumentsincludingapparatusandequipmentforself-testingwhichhereafterarecalledIVDinstruments.NOTE1InstructionsforuseareessentialtoenablethesafeandproperoperationofIVDinstrumentsbylaypersons.NOTE2Thisstandardcanalsobeappliedtoaccessories.Thisstandardisnotapplicabletofieldrepairinstructions.
【中国标准分类号】:C31
【国际标准分类号】:11_100_10
【页数】:14P.;A4
【正文语种】:英语
【英文标准名称】:StandardGuideforValidationofLaboratoryInformationManagementSystems
【原文标准名称】:实验室信息管理系统的鉴定标准导则
【标准号】:ASTME2066-2000(2007)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:E13.15
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Validationisanimportantandmandatoryactivityforlaboratoriesthatfallunderregulatoryagencyreview.Suchlaboratoriesproducedatauponwhichthegovernmentdependstoenforcelawsandmakedecisionsinthepublicinterest.Examplesincludedatatosupportapprovalofnewdrugs,provemarketeddrugsmeetspecifications,enforceenvironmentallaws,anddevelopforensicevidencefortrial.ThisalsoextendstoLIMSusedinenvironmentallaboratories.InsomecasesthesesystemsmayneedtobeinteroperablewithCLIMSandcomputer-basedpatientrecords(CPR)forreportingenvironmentalexposuresandclinicallaboratorytestingforbiologicmeasureofstressorexposure.Theenormousfinancial,legal,andsocialimpactofthesedecisionsrequiresgovernmentandpublicconfidenceinlaboratorydata.Toensurethisconfidence,governmentagenciesregularlyreviewlaboratoriesoperatingundertheirrulestoconfirmthattheyareproducingvaliddata.Computersystemvalidationisapartofthisreview.ThisguideisdesignedtoaidusersvalidatingLIMSandincorporatingthevalidationprocessintotheirLIMSlifecycle.Validationmustprovideevidenceoftesting,training,auditandreview,managementresponsibility,designcontrol,anddocumentcontrol,bothduringthedevelopmentofthesystemanditsoperationlife(2).1.1ThisguidedescribesanapproachtothevalidationprocessforaLaboratoryInformationManagementSystem(LIMS).1.2ThisguideisforvalidationofacommercialLIMSpurchasedfromavendor.Theproceduresmayapplytoothertypesofsystems,butthisguidemakesnoclaimtoaddressallissuesforothertypesofsystems.Further,in-housedevelopedLIMS,thatis,thosedevelopedbyinternalorexternalprogrammersspecificallyforanorganization,canutilizethisguide.Itshouldbenotedthatthereareanumberofrelatedsoftwaredevelopmentissuesthatthisguidedoesnotaddress.UserswhoembarkondevelopingaLIMSeitherinternallyorwithexternalprogrammersalsoshouldconsulttheappropriateASTM,ISO,andIEEEsoftwaredevelopmentstandards.1.3ThisguideisintendedtoeducateindividualsonLIMSvalidation,toprovidestandardterminologyusefulindiscussionswithindependentvalidationconsultants,andtoprovideguidancefordevelopmentofvalidationplans,testplans,requiredstandardoperatingprocedures,andthefinalvalidationreport.
【中国标准分类号】:N07
【国际标准分类号】:35_240_80
【页数】:25P.;A4
【正文语种】:
