ISO 13408-5-2006 保健产品的无菌加工.第5部分:现场消毒
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【英文标准名称】:Asepticprocessingofhealthcareproducts-Part5:Sterilizationinplace
【原文标准名称】:保健产品的无菌加工.第5部分:现场消毒
【标准号】:ISO13408-5-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-11
【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;清洁处理;定义;保健;医疗卫生事业;隔离器;医疗技术;人员;质量保证;规范(验收);无菌;监督(认可);培训;证实
【英文主题词】:Aseptic;Cleaning;Definitions;Healthprotection;Healthservices;Insulators;Medicaltechnology;Personnel;Qualityassurance;Specification(approval);Sterility;Surveillance(approval);Training;Validation
【摘要】:ThispartofISO13408specifiesthegeneralrequirementsforsterillizationinplace(SIP)appliedtoproductcontactsurfacesoftheequipmentusedinthemanufactureofsterilehealthcareproductsbyasepticprocessingandoffersguidanceonqualification,validation,operationandcontrol.1.2ThispartofISO13408appliestoprocesseswheresterilizingagentaredeliveredtotheinternalsurfacesofequipmentthatcancomeincontactwiththeproduct.1.3ThispartofISO13408doesnotapplytoprocesseswhereequipmentisdismantledanddeliveredtoasterilizer.1.4ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirementsthatpertaininparticularnationalorregionaljurisdictions.1.5ThispartofISO13408doesnotspecifyrequirementsfordevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathies,suchasscrapie,bovinespongiformencephlopathyandCreutzfeldt-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.
【中国标准分类号】:C53
【国际标准分类号】:11_080_01
【页数】:14P;A4
【正文语种】:英语
【原文标准名称】:保健产品的无菌加工.第5部分:现场消毒
【标准号】:ISO13408-5-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-11
【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;清洁处理;定义;保健;医疗卫生事业;隔离器;医疗技术;人员;质量保证;规范(验收);无菌;监督(认可);培训;证实
【英文主题词】:Aseptic;Cleaning;Definitions;Healthprotection;Healthservices;Insulators;Medicaltechnology;Personnel;Qualityassurance;Specification(approval);Sterility;Surveillance(approval);Training;Validation
【摘要】:ThispartofISO13408specifiesthegeneralrequirementsforsterillizationinplace(SIP)appliedtoproductcontactsurfacesoftheequipmentusedinthemanufactureofsterilehealthcareproductsbyasepticprocessingandoffersguidanceonqualification,validation,operationandcontrol.1.2ThispartofISO13408appliestoprocesseswheresterilizingagentaredeliveredtotheinternalsurfacesofequipmentthatcancomeincontactwiththeproduct.1.3ThispartofISO13408doesnotapplytoprocesseswhereequipmentisdismantledanddeliveredtoasterilizer.1.4ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirementsthatpertaininparticularnationalorregionaljurisdictions.1.5ThispartofISO13408doesnotspecifyrequirementsfordevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathies,suchasscrapie,bovinespongiformencephlopathyandCreutzfeldt-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.
【中国标准分类号】:C53
【国际标准分类号】:11_080_01
【页数】:14P;A4
【正文语种】:英语
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