BS EN ISO 8871-3-2004 非肠道及制药设备用弹性件.释放粒子计数的测定

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【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticalsuse-Determinationofreleased-particlecount
【原文标准名称】:非肠道及制药设备用弹性件.释放粒子计数的测定
【标准号】:BSENISO8871-3-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-06-09
【实施或试行日期】:2004-06-09
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:名称与符号;药剂;可见的;注射;制备;药物;医学;橡胶制品;包装件;特性记述;制药技术;输血设备;注射器械;弹性体;多语种的;规范(验收);试验;材料;检验;分类;识别;医疗设备;规范;医学科学;可见性;医疗技术学;漂洗;硫化橡胶;胃肠外注入设备;药品管理;含水的;储存;输注;输注;作标记;橡胶;包装手段
【英文主题词】:Aqueous;Bloodtransfusionequipment;Characterisations;Classification;Designations;Drugadministration;Drugs;Elastomers;Identification;Infusions;Injectioninstruments;Injections;Inspection;Marking;Materials;Meansofpackaging;Medicalequipment;Medicalsciences;Medicaltechnology;Medicaments;Medicine;Multilingual;Packages;Parenteralinfusionequipment;Pharmaceuticaltechnology;Preparations;Rinsing;Rubber;Rubberproducts;Specification(approval);Specifications;Storage;Testing;Transfusions;Visible;Visibleness;Vulcanizedrubber
【摘要】:Elastomericclosuresmaybesuperficiallycontaminatedwithvisibleandsubvisibleparticles,andfragmentscanalsobeproducedwhentheclosureispiercedbyaneedle.Suchparticlesmaybetransferredtopharmaceuticalpreparationsincontactwiththeelastomericpartsandaffectthequalityofsuchpreparations.ThispartofISO8871specifiesmethodsforthedeterminationofthenumberofvisibleandsubvisibleparticles,respectively,detachedfromelastomericpartsbyrinsing.Itdoesnotspecifyparticlecontaminationlimits.Thesewillhavetobeagreeduponbetweenmanufactureranduser.
【中国标准分类号】:C92
【国际标准分类号】:11_040_20
【页数】:18P.;A4
【正文语种】:英语