DIN EN ISO 80369-1-2011 卫生保健应用中液体和气体用小口径连接器.第1部分:一般要求(ISO80369-1-2010);德文版本ENISO80369-1-2010
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【英文标准名称】:Smallboreconnectorsforliquidsandgasesinhealthcareapplications-Part1:Generalrequirements(ISO80369-1:2010);GermanversionENISO80369-1:2010
【原文标准名称】:卫生保健应用中液体和气体用小口径连接器.第1部分:一般要求(ISO80369-1-2010);德文版本ENISO80369-1-2010
【标准号】:DINENISO80369-1-2011
【标准状态】:现行
【国别】:德国
【发布日期】:2011-04
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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-boreconnectorswhichconveyliquidsorgasesinhealthcareapplications.TheseSMALL-BORECONNECTORSareusedinMEDICALDEVICESorACCESSORIESintendedforusewithaPATIENT.ThisInternationalStandardalsospecifiesthehealthcarefieldsinwhichtheseSMALL-BORECONNECTORSareintendedtobeused.Thesehealthcarefieldsofuseinclude,butarenotlimitedto,Applicationsfor:-Breathingsystemsanddrivinggases,-enterealandgastric,-urethrealandurinary,-limbcuffinflation,-neuraxialdevices,and-intravascularorhypodermic.SMALL-BORECONNECTORSasspecifiedinthisInternationalStandardareNON-INTERCONNECTABLEwith:-theconesandsocketsofISO5356-1:2004andISO5356-2:2006;-thetemperaturesensorCONNCETORandmatingportsspecifiedinAnnexDDofISO8185:2007;and-thenipplesofEN13544-2:2002ThisInternationalStandardprovidesthemethodologytoassessNON-INTERCONNCETABLEcharacteristicsofSMALL-BORECONNCETORSbasedontheirinherentdesignanddimensionsinordertoreducetheRiskofmedicaldevicesorbetweenaccessoriesfordifferentapplicationsandtoreducetheriskofmiconnectionsbetweenmicaldeviceswith6%LuerConnectors,andallothernon-Luerconnectorsthatwillbedevelopedunderfuturepartsofthisseriesofstandards.Itdoesnotspecifyrequirementsforthemedicaldevicesoraccessoriesthatusethesesmall-boreconnectors.SuchrequirementsaregiveninparticularInternatioanlStandardsforspecificmedicaldevicesoraccessories.
【中国标准分类号】:
【国际标准分类号】:11_040_10;11_040_20
【页数】:29P.;A4
【正文语种】:德语
【原文标准名称】:卫生保健应用中液体和气体用小口径连接器.第1部分:一般要求(ISO80369-1-2010);德文版本ENISO80369-1-2010
【标准号】:DINENISO80369-1-2011
【标准状态】:现行
【国别】:德国
【发布日期】:2011-04
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【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-boreconnectorswhichconveyliquidsorgasesinhealthcareapplications.TheseSMALL-BORECONNECTORSareusedinMEDICALDEVICESorACCESSORIESintendedforusewithaPATIENT.ThisInternationalStandardalsospecifiesthehealthcarefieldsinwhichtheseSMALL-BORECONNECTORSareintendedtobeused.Thesehealthcarefieldsofuseinclude,butarenotlimitedto,Applicationsfor:-Breathingsystemsanddrivinggases,-enterealandgastric,-urethrealandurinary,-limbcuffinflation,-neuraxialdevices,and-intravascularorhypodermic.SMALL-BORECONNECTORSasspecifiedinthisInternationalStandardareNON-INTERCONNECTABLEwith:-theconesandsocketsofISO5356-1:2004andISO5356-2:2006;-thetemperaturesensorCONNCETORandmatingportsspecifiedinAnnexDDofISO8185:2007;and-thenipplesofEN13544-2:2002ThisInternationalStandardprovidesthemethodologytoassessNON-INTERCONNCETABLEcharacteristicsofSMALL-BORECONNCETORSbasedontheirinherentdesignanddimensionsinordertoreducetheRiskofmedicaldevicesorbetweenaccessoriesfordifferentapplicationsandtoreducetheriskofmiconnectionsbetweenmicaldeviceswith6%LuerConnectors,andallothernon-Luerconnectorsthatwillbedevelopedunderfuturepartsofthisseriesofstandards.Itdoesnotspecifyrequirementsforthemedicaldevicesoraccessoriesthatusethesesmall-boreconnectors.SuchrequirementsaregiveninparticularInternatioanlStandardsforspecificmedicaldevicesoraccessories.
【中国标准分类号】:
【国际标准分类号】:11_040_10;11_040_20
【页数】:29P.;A4
【正文语种】:德语
下载地址: 点击此处下载