【英文标准名称】:Smallboreconnectorsforliquidsandgasesinhealthcareapplications.Generalrequirements
【原文标准名称】:卫生健康设施中液体和气体用小型孔连接器.一般要求
【标准号】:BSENISO80369-1-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2011-07-31
【实施或试行日期】:2011-07-31
【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】:
【英文主题词】:Accessories;Cleanability;Cleaning;Connectingpieces;Connections;Definitions;Diameter;Disinfections;Gases;Liquids;Materials;Medicaldevices;Medicalequipment;Medicalgases;Medicaltechnology;Non-interchangeability;Non-interchangeable;Riskanalysis;Small;Specification(approval)
【摘要】:ThispartofISO80369specifiesgeneralrequirementsforSMALL-BORECONNECTORS,whichconveyliquidsorgasesinhealthcareAPPLICATIONS.TheseSMALL-BORECONNECTORSareusedinMEDICALDEVICESorACCESSORIESintendedforusewithaPATIENT.ThisInternationalStandardalsospecifiesthehealthcarefieldsinwhichtheseSMALL-BORECONNECTORSareintendedtobeused.Thesehealthcarefieldsofuseinclude,butarenotlimitedto,APPLICATIONSfor:-BREATHINGSYSTEMSanddrivinggases,-enteralandgastric,-urethralandurinary,-limbcuffinflation,-neuraxialdevices,and-intravascularorhypodermic.SMALL-BORECONNECTORSasspecifiedinthisInternationalStandardareNON-INTERCONNECTABLEwith:-theconesandsocketsofISO5356-1:2004andISO5356-2:2006;-thetemperaturesensorCONNECTORandmatingportsspecifiedinAnnexDDofISO8185:2007;and-thenipplesofEN13544-2:2002.ThisInternationalStandardprovidesthemethodologytoassessNON-INTERCONNECTABLEcharacteristicsofSMALL-BORECONNECTORSbasedontheirinherentdesignanddimensionsinordertoreducetheRISKofmisconnectionsbetweenMEDICALDEVICESorbetweenACCESSORIESfordifferentAPPLICATIONSandtoreducetheRISKofmisconnectionsbetweenMEDICALDEVICESwith6%LuerCONNECTORS,andallothernon-LuerCONNECTORSthatwillbedevelopedunderfuturepartsofthisseriesofstandards.ItdoesnotspecifyrequirementsfortheMEDICALDEVICESorACCESSORIESthatusetheseSMALL-BORECONNECTORS.SuchrequirementsaregiveninparticularInternationalStandardsforspecificMEDICALDEVICESorACCESSORIES.
【中国标准分类号】:C31
【国际标准分类号】:11_040_10;11_040_20
【页数】:30P.;A4
【正文语种】:英语