BS EN 14136-2004 体外诊断检验程序的性能评定中外部质量评定方案的使用

作者:标准资料网 时间:2024-05-17 12:42:59  浏览:8708   来源:标准资料网

【英文标准名称】:Useofexternalqualityassessmentschemesintheassessmentoftheperformanceofinvitrodiagnosticexaminationprocedures
【原文标准名称】:体外诊断检验程序的性能评定中外部质量评定方案的使用
【标准号】:BSEN14136-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-05-26
【实施或试行日期】:2004-05-26
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:ThisEuropeanStandardappliestoexternalqualityassessmentschemes,hereaftercalledEQAS,thatincludeintheirfunctionstheassessmentandevaluationoftheperformanceofspecifiedinvitrodiagnosticprocedures(includinginvitrodiagnosticmedicaldevices,hereaftercalledIVDMDs).ItsetsouttherequirementsthatarenecessarytoenableEQAStofulfilthisfunctionrelatingto:—schemedesignandorganisation;—identificationofprocedures(IVDMDs)usedbytheparticipant;—classificationandevaluationofdata.NOTEExternalqualityassessmentdatageneratedaccordingtothesecriteriawillhelpmanufacturers,usersorcompetentauthoritiestomonitorindependentlythepost-marketingperformanceofIVDMDs.ThisEuropeanStandarddoesnotspecifywaysinwhichEQASthemselvesareorganised,norhowtheindividualorcollectiveperformanceofclinicallaboratoriesisevaluated.
【中国标准分类号】:C05
【国际标准分类号】:11_100_10
【页数】:14P;A4
【正文语种】:英语