【英文标准名称】:Small-boreconnectorsforliquidsandgasesinhealthcareapplications—Part1:Generalrequirements
【原文标准名称】:医疗保健设施中液体与气体用小型孔连接器.第1部分:一般要求
【标准号】:ISO80369-1-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-12-15
【实施或试行日期】:2010-12-15
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【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;Medicalequipment;Medicalgases;Medicaltechnology;Non-interchangeability;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.NOTE1ItisintendedthatnewdesignsofSMALL-BORECONNECTORSwillbeincludedinthisseriesofstandardsaftertheyhavebeenassessedaccordingtothePROCEDUREgiveninClause6.NOTE2MANUFACTURERSareencouragedtoincorporatetheSMALL-BORECONNECTORSspecifiedinthisseriesofstandardsintoMEDICALDEVICES,medicalsystemsorACCESSORIES,evenifcurrentlynotrequiredbytherelevantparticularMEDICALDEVICEstandards.ItisexpectedthatwhentherelevantparticularMEDICALDEVICEstandardsarerevised,requirementsforSMALL-BORECONNECTORSasspecifiedintheseriesofstandardswillbeincluded.NOTE3MANUFACTURERSandRESPONSIBLEORGANIZATIONSareencouragedtoreporttheirexperiencewiththeSMALL-BORECONNECTORSspecifiedinthisseriesofstandardstotheSecretariatofISO/TC210toconsiderthisfeedbackduringtherevisionoftherelevantpartofthisseriesofstandards.
【中国标准分类号】:
【国际标准分类号】:11_040_10;11_040_20
【页数】:24P.;A4
【正文语种】:英语