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【英文标准名称】:Invitrodiagnosticmedicaldevices-Single-usereceptaclesforthecollectionofspecimens,otherthanblood,fromhumans
【原文标准名称】:体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器
【标准号】:BSEN14254-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-07-06
【实施或试行日期】:2004-07-06
【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】:Thisstandardspecifiesrequirementsandtestmethodsforsingle-useevacuatedandnon-evacuatedreceptacles,intendedbytheirmanufacturers,fortheprimarycontainmentandpreservationofspecimens,otherthanbloodspecimens,derivedfromthehumanbody,forthepurposesofinvitrodiagnosticexamination.NOTE1Requirementsandtestmethodsforevacuatedandnon-evacuatedsingle-usevenousbloodspecimencontainersarespecifiedinEN14820.NOTE2Whileitisdesirablethatspecimenreceptaclesshouldbedesignedtoavoidspontaneousdischargeofthecontents,whenbeingopened,thisstandarddoesnotspecifyatestprocedureforthisbecauseithasnotbeenpossibletodeviseanobjectiveandreproducibletest.Thisstandarddoesnotspecifyrequirementsforcollectionneedlesorneedleholdersorotheraccessoriesusedinconjunctionwithspecimenreceptacles.
【中国标准分类号】:C44
【国际标准分类号】:11_100_10
【页数】:22P;A4
【正文语种】:英语