【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Identificationandcharacterization
【原文标准名称】:非肠道及制药设备用弹性件.识别和特性
【标准号】:BSENISO8871-2-2004
【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】:
【英文主题词】:
【摘要】:ThispartofISO8871specifiesevaluationproceduresapplicabletoelastomericpartsusedfordrugcontainersandmedicaldevicesinordertoguaranteetheproductidentitybetweenthesamplesevaluatedinthe(suitabilitytest)acceptanceprocessandthecurrentsupplies.ThephysicalandchemicaltestproceduresspecifiedinthispartofISO8871permitthedeterminationofthetypicalcharacteristicsofrubbermaterials,andmayserveasabasisforagreementsbetweenmanufactureranduserregardingtheproductconsistencyinsubsequentsupplies.Anappropriatesetoftestsisselected,dependinguponthetypeofrubberanditsapplication.ThispartofISO8871doesnotspecifyotherrequirementsforrubbermaterials.Thesearelaiddownintherelevantproductstandards.
【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