【英文标准名称】:Needle-freeinjectorsformedicaluse-Requirementsandtestmethods(ISO21649:2006);GermanversionENISO21649:2006
【原文标准名称】:医用非针头式注射器.要求和试验方法
【标准号】:DINENISO21649-2006
【标准状态】:作废
【国别】:德国
【发布日期】:2006-09
【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】:定义;用后即丢弃的;一次性使用设备;注射器械;注射;喷射器;检验;使用说明;作标记;测量不确定度;医疗设备;医学科学;规范(验收);试验;试验条件
【英文主题词】:Definitions;Disposable;Disposables;Drugadministration;Equipmentforsingleuse;Injectioninstruments;Injections;Injectors;Inspection;Instructionsforuse;Marking;Measuringincertainity;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Reuse;Specification(approval);Testing;Testingconditions
【摘要】:ThisInternationalStandardappliestosafetyandperformanceandtestingrequirementsforsingle-useandmultiple-useneedle-freeinjectionsystemsintendedforhumanuseinclinicsandothermedicalsettingsandforpersonalusebypatients.Thedosechamberoftheinjectionsystemisoftendisposableandintendedtobereplacedaftereitherasingleuseoralimitednumberofuses.Itissometimesseparablefromtheinjectionmechanismandoftentermeda"cartridge","ampoule","syringe","capsule"or"disc".Incontrast,thedosechamberalsomaybeapermanentinternalchamberdesignedtolastthroughtheclaimedlifeofthedevice.ExcludedfromthisInternationalStandardaredrugdeliverymethodswhich:—involvepenetrationofapartofthedeviceitselfintoorthroughskinormucousmembranes(suchasneedles,tines,micro-needles,implantableslow-releasedrugdevices);—generateaerosols,droplets,powdersorotherformulationsforinhalation,insufflation,intranasalororaldeposition(suchassprays,inhalers,misters);—depositliquids,powders,orothersubstancesonthesurfaceofskinormucosalsurfacesforpassivediffusionoringestionintothebody(suchastransdermalpatches,liquiddrops);—applysonicorelectromagneticenergy(suchasultrasonicoriontophoreticdevices);—infusionsystemsforaddingormeteringmedicationintoorthroughsystemsofartificialtubes,catheters,and/orneedleswhichthemselvesenterthebody.
【中国标准分类号】:C31
【国际标准分类号】:11_040_25
【页数】:40P.;A4
【正文语种】:德语