【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Part2:Identificationandcharacterization
【原文标准名称】:非肠道及制药设备用弹性件.第2部分:鉴别和表征
【标准号】:ISO8871-2-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-10
【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】:包装件;作标记;检验;材料;规范;试验;胃肠外注入设备;硫化橡胶;储存;规范(验收);医学科学;表征;药物;橡胶制品;注射;药品管理;输注;输注;注射器械;包装手段;输血设备;弹性体;医疗设备;识别
【英文主题词】:Analysis;Aqueous;Bloodtransfusionequipment;Characterisations;Chemicalanalysisandtesting;Chemicalcomposition;Classification;Containers;Definitions;Designations;Drugadministration;Drugcontainers;Drugs;Elastomers;Identification;Infusions;Injectioninstruments;Injections;Inspection;Marking;Materials;Meansofpackaging;Medicalequipment;Medicalsciences;Medicaltechnology;Multilingual;Packages;Parenteralinfusionequipment;Pharmacy;Preparation;Properties;Qualificationtests;Rubber;Rubberproducts;Specification(approval);Specifications;Storage;Substances;Testing;Transfusions;Vulcanizedrubber
【摘要】:ThispartofISO8871specifiesevaluationproceduresapplicabletoelastomericpartsusedfordrugcontainersandmedicaldevicesinordertoguaranteetheproductidentitybetweenthesamplesevaluatedinthe(suitabilitytest)acceptanceprocessandthecurrentsupplies.ThephysicalandchemicaltestproceduresspecifiedinthispartofISO8871permitthedeterminationofthetypicalcharacteristicsofrubbermaterials,andmayserveasabasisforagreementsbetweenmanufactureranduserregardingtheproductconsistencyinsubsequentsupplies.Anappropriatesetoftestsisselected,dependinguponthetypeofrubberanditsapplication.ThispartofISO8871doesnotspecifyotherrequirementsforrubbermaterials.Thesearelaiddownintherelevantproductstandards.
【中国标准分类号】:C36
【国际标准分类号】:11_040_20
【页数】:20P;A4
【正文语种】:英语