ISO 7886-3-2005 一次性使用无菌皮下注射器.第3部分: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-Part3:Auto-disablesyringesforfixed-doseimmunization
【原文标准名称】:一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器
【标准号】:ISO7886-3-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC84
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗产品;尺寸;性能;医疗设备;加标签;注射器;医学科学;电动输液仪;一次性注射器;定义;规范(验收);无菌设备
【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;Syringes;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】:13P;A4
【正文语种】:英语
【原文标准名称】:一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器
【标准号】:ISO7886-3-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC84
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗产品;尺寸;性能;医疗设备;加标签;注射器;医学科学;电动输液仪;一次性注射器;定义;规范(验收);无菌设备
【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;Syringes;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】:13P;A4
【正文语种】:英语
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