BS EN ISO 7886-3-2009 一次性使用无菌皮下注射器.固定剂量免疫接种用自动报废注射器

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【英文标准名称】:Sterilehypodermicsyringesforsingleuse-Auto-disablesyringesforfixed-doseimmunization
【原文标准名称】:一次性使用无菌皮下注射器.固定剂量免疫接种用自动报废注射器
【标准号】:BSENISO7886-3-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-11-30
【实施或试行日期】:2009-11-30
【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】:组件;定义;尺寸;可处置的;保健;注射器械;注射器;联锁装置;加标签;标志;医疗器械;医疗设备;医疗产品;医学科学;包装件;性能;塑料;动力输液器;一次性注射器;规范(验收);不锈钢;无菌设备;测试
【英文主题词】:Components;Definitions;Dimensions;Disposables;Healthprotection;Injectioninstruments;Injectionsyringes;Interlocks;Labelling;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Packages;Performance;Plastics;Powerinfusionapparatus;Singleusesyringes;Specification(approval);Stainlesssteels;Sterileequipment;Testing
【摘要】:ThispartofISO7886specifiesthepropertiesandperformanceofsterilesingle-usehypodermicsyringeswithorwithoutneedle,madeofplasticmaterialsandstainlesssteelandintendedfortheaspirationofvaccinesorfortheinjectionofvaccinesimmediatelyafterfilling.Upondeliveringafixeddoseofvaccine,thesyringeisautomaticallyrenderedunusable.ThispartofISO7886doesnotspecifythedesignoftheauto-disablefeature,whichislefttothediscretionofthemanufacturer.ThispartofISO7886isnotapplicabletosyringesforusewithinsulin(specifiedinISO8537),syringesmadeofglass(specifiedinISO595),syringesforusewithpower-drivensyringepumps(specifiedinISO7886-2),auto-disablesyringesforvariabledosedeliveryandsyringesdesignedtobeprefilled.Itdoesnotaddresscompatibilitywithinjectionfluids/vaccines.NOTEAfourthpartofISO7886isbeingpreparedtocoversyringeswithreusepreventionfeature.
【中国标准分类号】:C31
【国际标准分类号】:11_040_25
【页数】:24P.;A4
【正文语种】:英语