BS EN ISO 8871-1-2004 非肠道及制药设备用弹性件.水蒸压器中的萃取物

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【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Extractablesinaqueousautoclavates
【原文标准名称】:非肠道及制药设备用弹性件.水蒸压器中的萃取物
【标准号】:BSENISO8871-1-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-09-08
【实施或试行日期】:2004-09-08
【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】:药品管理;输注;输注;注射;提取的;制备;橡胶制品;含水的;名称与符号;注射器械;药剂学;橡胶;识别;包装件;弹性体;检验;医疗设备;物质;包装手段;规范(验收);硫化橡胶;药物;医学科学;胃肠外注入设备;医疗技术学;多语种的;试验;规范;作标记;材料;极限(数学);分类;输血设备;储存
【英文主题词】:
【摘要】:1ThispartofISO8871definesproceduresforclassifyingelastomericpartsforprimarypacksandmedicaldevicesusedindirectcontactwithpreparationsforparenteraluse,includingbothaqueouspreparationsanddrypreparationswhichhavetobedissolvedbeforeuse.Itspecifiesaseriesofcomparativetestmethodsforchemicalevaluationbythedeterminationofextractablesinaqueousautoclavates(seeClause4)anddescribesthevariousfieldsofapplicationforelastomericparts.DimensionsandfunctionalcharacteristicsarespecifiedintherelevantInternationalStandards.RequiredpropertiesasspecifiedinthispartofISO8871areregardedasminimumrequirements.2ThispartofISO8871isapplicableforthecategoriesofelastomericpartsgiveninClause3;specificrequirements,however,arelaiddownintherelevantInternationalStandardsdealingwiththeitemsordeviceslistedinClause3.ElastomericpartsforemptysyringesforsingleuseareexcludedfromthescopeofthispartofISO8871astheyarenotincontactwiththeinjectedpreparationforasignificantlengthoftime.3Compatibilitystudieswiththeintendedpreparationhavetobeperformedbeforetheapprovalforfinalusecanbegiven;however,thispartofISO8871doesnotspecifyproceduresforcarryingoutcompatibilitystudies.
【中国标准分类号】:C92
【国际标准分类号】:11_040_20
【页数】:32P;A4
【正文语种】:英语