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【英文标准名称】:Asepticprocessingofhealthcareproducts-Part1:Generalrequirements
【原文标准名称】:医疗保健产品的无菌加工.第1部分:一般要求
【标准号】:ISO13408-1-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-06
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:无菌的;检验;定义;医疗卫生事业;制造;医疗技术学;生产;质量;质量保证;规范(验收);无菌
【英文主题词】:Aseptic;Checks;Definitions;Healthservices;Manufacturing;Medicaltechnology;Production;Quality;Qualityassurance;Specification(approval);Sterility
【摘要】:1.1ThispartofISO13408specifiesthegeneralrequirementsfor,andoffersguidanceon,processes,programmesandproceduresfordevelopment,validationandroutinecontrolofthemanufacturingprocessforaseptically-processedhealthcareproducts.1.2ThispartofISO13408includesrequirementsandguidancerelativetotheoveralltopicofasepticprocessing.Specificrequirementsandguidanceonvariousspecializedprocessesandmethodsrelatedtofiltration,lyophilization,clean-inplace(CIP)technologies,sterilizationinplace(SIP)andisolatorsystemsaregiveninotherpartsofISO13408.NOTEThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orpharmacopoeialrequirementsthatpertaininparticularnationalorregionaljurisdictions.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01
【页数】:54P.;A4
【正文语种】:英语