ISO 8871-1-2003 非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物
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【英文标准名称】:Elastomericpartsforparenteralsandfordevicesforpharmaceuticaluse-Part1:Extractablesinaqueousautoclavates
【原文标准名称】:非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物
【标准号】:ISO8871-1-2003
【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】:识别;医疗设备;弹性体;输血设备;包装手段;药剂学;注射器械;输注;输注;药品管理;注射;橡胶制品;药物;医学科学;规范(验收);储存;硫化橡胶;胃肠外注入设备;试验;规范;材料;检验;作标记;包装件
【英文主题词】:Aqueous;Bloodtransfusionequipment;Classification;Designations;Drugadministration;Drugs;Elastomers;Extractable;Identification;Infusions;Injectioninstruments;Injections;Inspection;Limits(mathematics);Marking;Materials;Meansofpackaging;Medicalequipment;Medicalsciences;Medicaltechnology;Multilingual;Packages;Parenteralinfusionequipment;Pharmacy;Preparation;Rubber;Rubberproducts;Specification(approval);Specifications;Storage;Substances;Testing;Transfusions;Vulcanizedrubber
【摘要】:1ThispartofISO8871definesproceduresforclassifyingelastomericpartsforprimarypacksandmedicaldevicesusedindirectcontactwithpreparationsforparenteraluse,includingbothaqueouspreparationsanddrypreparationswhichhavetobedissolvedbeforeuse.Itspecifiesaseriesofcomparativetestmethodsforchemicalevaluationbythedeterminationofextractablesinaqueousautoclavates(seeClause4)anddescribesthevariousfieldsofapplicationforelastomericparts.DimensionsandfunctionalcharacteristicsarespecifiedintherelevantInternationalStandards.RequiredpropertiesasspecifiedinthispartofISO8871areregardedasminimumrequirements.2ThispartofISO8871isapplicableforthecategoriesofelastomericpartsgiveninClause3;specificrequirements,however,arelaiddownintherelevantInternationalStandardsdealingwiththeitemsordeviceslistedinClause3.ElastomericpartsforemptysyringesforsingleuseareexcludedfromthescopeofthispartofISO8871astheyarenotincontactwiththeinjectedpreparationforasignificantlengthoftime.3Compatibilitystudieswiththeintendedpreparationhavetobeperformedbeforetheapprovalforfinalusecanbegiven;however,thispartofISO8871doesnotspecifyproceduresforcarryingoutcompatibilitystudies.
【中国标准分类号】:C36
【国际标准分类号】:11_040_20
【页数】:19P;A4
【正文语种】:英语
【原文标准名称】:非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物
【标准号】:ISO8871-1-2003
【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】:识别;医疗设备;弹性体;输血设备;包装手段;药剂学;注射器械;输注;输注;药品管理;注射;橡胶制品;药物;医学科学;规范(验收);储存;硫化橡胶;胃肠外注入设备;试验;规范;材料;检验;作标记;包装件
【英文主题词】:Aqueous;Bloodtransfusionequipment;Classification;Designations;Drugadministration;Drugs;Elastomers;Extractable;Identification;Infusions;Injectioninstruments;Injections;Inspection;Limits(mathematics);Marking;Materials;Meansofpackaging;Medicalequipment;Medicalsciences;Medicaltechnology;Multilingual;Packages;Parenteralinfusionequipment;Pharmacy;Preparation;Rubber;Rubberproducts;Specification(approval);Specifications;Storage;Substances;Testing;Transfusions;Vulcanizedrubber
【摘要】:1ThispartofISO8871definesproceduresforclassifyingelastomericpartsforprimarypacksandmedicaldevicesusedindirectcontactwithpreparationsforparenteraluse,includingbothaqueouspreparationsanddrypreparationswhichhavetobedissolvedbeforeuse.Itspecifiesaseriesofcomparativetestmethodsforchemicalevaluationbythedeterminationofextractablesinaqueousautoclavates(seeClause4)anddescribesthevariousfieldsofapplicationforelastomericparts.DimensionsandfunctionalcharacteristicsarespecifiedintherelevantInternationalStandards.RequiredpropertiesasspecifiedinthispartofISO8871areregardedasminimumrequirements.2ThispartofISO8871isapplicableforthecategoriesofelastomericpartsgiveninClause3;specificrequirements,however,arelaiddownintherelevantInternationalStandardsdealingwiththeitemsordeviceslistedinClause3.ElastomericpartsforemptysyringesforsingleuseareexcludedfromthescopeofthispartofISO8871astheyarenotincontactwiththeinjectedpreparationforasignificantlengthoftime.3Compatibilitystudieswiththeintendedpreparationhavetobeperformedbeforetheapprovalforfinalusecanbegiven;however,thispartofISO8871doesnotspecifyproceduresforcarryingoutcompatibilitystudies.
【中国标准分类号】:C36
【国际标准分类号】:11_040_20
【页数】:19P;A4
【正文语种】:英语
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