BS EN 13640-2002 体外诊断试剂的稳定性试验

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【英文标准名称】:Stabilitytestingofinvitrodiagnosticreagents
【原文标准名称】:体外诊断试剂的稳定性试验
【标准号】:BSEN13640-2002
【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】:真实时间;定义;定义;在实验室条件下;稳定性;信息;多语种的;医学科学;医疗产品;试剂;化学分析和试验;生物化学制品;耐久性;试剂溶液;试验;诊断(医学);诊断;校正;检查材料;实验室条件下诊断;校验器;规范(验收);储存
【英文主题词】:Biochemicals;Calibration;Calibrator;Checkmaterial;Chemicalanalysisandtesting;Definition;Definitions;Diagnosis;Diagnosis(medical);Durability;Invitro;Information;In-vitrodiagnostic;Medicalproducts;Medicalsciences;Multilingual;Reagentsolutions;Reagents;Real-time;Specification(approval);Stability;Storage;Testing
【摘要】:ThisEuropeanStandardisapplicabletothestabilitytestingofinvitrodiagnosticreagentsincludingreagentproducts,calibrators,controlmaterialsandkits,hereinaftercalledIVDreagents.Itspecifiesgeneralrequirementsforstabilitytestingandgivesspecificrequirementsforreal-timetestingandacceleratedtestingwhengeneratingstabilitydatainthe-determinationofIVDreagentshelf-lifeincludingtransportstability;-determinationofstabilityoftheIVDreagentinuseafterthefirstopeningoftheprimarycontainer(e.g.on-boardstability);-monitoringofstabilityofIVDreagentsalreadyplacedonthemarket;-verificationofstabilityafterIVDreagentmodificationsthatmayaffectstability.Thisstandarddoesnotapplytoinstruments,apparatus,equipment,systems,orspecimenreceptacles.
【中国标准分类号】:C36
【国际标准分类号】:11_100_10
【页数】:14P.;A4
【正文语种】:英语