作者:标准资料网 时间:2024-05-19 15:19:58   浏览:9824   来源:标准资料网

【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Part3:Determinationofreleased-particlecount
【原文标准名称】:非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定
【标准号】:ISO8871-3-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-08
【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/TC76
【标准类型】:()
【标准水平】:()
【中文主题词】:检验;材料;包装件;分类;作标记;硫化橡胶;胃肠外注入设备;规范;多语种的;储存;医疗设备;医疗技术学;识别;弹性体;表征;医学科学;规范(验收);可视性;输血设备;名称与符号;包装手段;冲洗;试验;输注;输注;医药;药品管理;橡胶;制药技术;医学;注射器械;含水的;药物;制备;橡胶制品;注射;可见的
【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;Preparation;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】:C36
【国际标准分类号】:11_040_20
【页数】:6P;A4
【正文语种】:英语