【英文标准名称】:Performanceevaluationofinvitrodiagnosticmedicaldevices
【原文标准名称】:体外诊断医疗装置的性能评估
【标准号】:BSEN13612-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-05-07
【实施或试行日期】:2002-05-07
【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】:自测;验证;在实验室条件下;效率;产品信息;质量保证;医学科学;实验室条件下诊断;评定;诊断;实验室医学;定义;定义;试剂;质量评定;诊断设备;作标记
【英文主题词】:
【摘要】:ThisEuropeanStandardappliestotheperformanceevaluationofinvitrodiagnosticmedicaldevices(IVDMDs)includingIVDMDsforself-testing.Itspecifiestheresponsibilitiesandgeneralrequirementsfortheplanning,conduct,assessmentanddocumentationofaperformanceevaluationstudybythemanufacturer.ItdoesnotapplytospecificevaluationplansforcertainIVDMDsoraspecificuse.NOTEForaselectionofpublicationsonspecificevaluationplansseeBibliography.Whereamanufacturermaintainsaqualitysystemthisstandardaddressesthecompliancewith"designvalidation"and"designchanges"asdescribedinENISO9001,EN46001andEN928especiallyconsideringthenatureanduseofIVDMDs.Inparticular,thisstandardappliestoIVDMDsto-showevidencetonotifiedbodiesandnationalauthoritiesbyresultsofaperformanceevaluationthattheIVDMDperformsasclaimedbythemanufacturer,-establishadequateperformanceevaluationdataoriginatingfromappropriatestudiesorresultingfromavailableliterature,andto-satisfytherequirementsofaqualitysystemfordesignvalidation.
【中国标准分类号】:C36
【国际标准分类号】:11_100_10
【页数】:18P;A4
【正文语种】:英语