BS EN ISO 7886-1-1997 一次性无菌皮下注射器.人工注射器

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【英文标准名称】:Sterilehypodermicsyringesforsingleuse.Syringesformanualuse
【原文标准名称】:一次性无菌皮下注射器.人工注射器
【标准号】:BSENISO7886-1-1997
【标准状态】:现行
【国别】:英国
【发布日期】:1997-09-15
【实施或试行日期】:1997-09-15
【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】:水解萃取法;耐化学性试验;定义(术语);设计;含量测定;尺寸公差;尺寸规格;可处置的;电阻率;电气测试;力的测量;划刻度;图形符号;注射器械;标签;漏泄试验;润滑剂;作标记;机械测试;医疗器材;医疗器械;嗅觉分析;包装;性能;位置;压力试验;还原剂;刻度;一次性注射器;规范(验收);分光光度法;无菌设备;注射器;试验设备;试验;测试条件;公差(测量);外观检查(测试);体积;容积测量
【英文主题词】:Aqueousextractionmethods;Chemical-resistancetests;Definitions;Design;Determinationofcontent;Dimensionaltolerances;Dimensions;Disposable;Electricalresistivity;Electricaltesting;Forcemeasurement;Graduations;Graphicsymbols;Injectioninstruments;Labels;Leaktests;Lubricants;Marking;Mechanicaltesting;Medicalequipment;Medicalinstruments;Olfactoryanalysis;Packaging;Performance;Position;Pressuretesting;Reducingagents;Scales;Singleusesyringes;Specification(approval);Spectrophotometry;Sterileequipment;Syringes;Testequipment;Testing;Testingconditions;Tolerances(measurement);Visualinspection(testing);Volume;Volumemeasurement
【摘要】:ThispartofISO7886specifiesrequirementsforsterilesingle-usehypodermicsyringesmadeofplas-ticsmaterialsandintendedfortheaspirationoffluidsorfortheinjectionoffluidsimmediatelyafterfilling.Itexcludessyringesforusewithinsulin(seeISO8537),single-usesyringesmadeofglass,syringeswithneedlespermanentlyattached,syringesforusewithpower-drivensyringepumps,syringespre-filledwiththeinjectionbythemanufacturerandsyringessuppliedwiththeinjectionasakitforfillingbyapharmacist.NOTE1AsecondpartofISO7886isbeingpreparedtocoversyringesforusewithpower-drivensyringepumps.
【中国标准分类号】:C31
【国际标准分类号】:11_040_25
【页数】:36P.;A4
【正文语种】:英语