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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:通用要求
【标准号】:ISO13408-1-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-08
【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;医疗卫生事业;无菌;规范(验收);定义;医疗技术学;质量保证
【英文主题词】:Aseptic;Definition;Definitions;Healthservices;Medicaltechnology;Qualityassurance;Specification(approval);Sterility
【摘要】:ThispartofISO13408specifiesthegeneralrequirementsfor,andoffersguidanceon,processes,programmesandproceduresforthevalidationandcontrolofasepticallyprocessedhealthcareproducts.ThispartofISO13408includesrequirementsandguidancerelativetotheoveralltopicofasepticprocessing.NOTEFuturepartsofISO13408willaddressspeciattytopicsrelatedtoasepticprocessing,includingdetaileddescriptiveinformationconcerningvariousspecializedprocessesandmethodsrelatedtofiltration,freeze-drying,sterilizationinplace,cleaninginplace,isolatortechnology,andsolidmedicaldevices.ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirements,thatpertaininparticulartonationalorregionaljurisdictions.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01;11_120_01
【页数】:31P.;A4
【正文语种】:英语