ISO 13408-4-2005 保健产品的无菌加工.第4部分:就地清洗技术
作者:标准资料网 时间:2024-05-19 22:21:23 浏览:9682
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Asepticprocessingofhealthcareproducts-Part4:Clean-in-placetechnologies
【原文标准名称】:保健产品的无菌加工.第4部分:就地清洗技术
【标准号】:ISO13408-4-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-11
【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;医疗卫生事业;医疗技术学;质量保证;规范(验收);无菌;证实
【英文主题词】:Aseptic;Cleaning;Definitions;Healthservices;Medicaltechnology;Qualityassurance;Specification(approval);Sterility;Validation
【摘要】:ThispartofISO13408specifiesthegeneralrequirementsforclean-in-place(CIP)processesappliedtoproductcontactsurfacesofequipmentusedinthemanufactureofsterilehealthcareproductsbyaseoticprocessingandoffersguidanceonqualification,validation,operationandcontrol.ThispartofISO13408isapplicabletoprocesseswherecleaningagentsarcdeliveredtotheinternalsurfacesofequipmentdesignedtobecompatiblewithCIP,whichmaycomeincontactwiththeproduct.ThispartofISO13408isnotapplicabletoprocesseswhereequipmentisdismantledandcleanedinawasher.ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirementsthatpertaintoparticularnationalorregionaljurisdictions.
【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4部分:就地清洗技术
【标准号】:ISO13408-4-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-11
【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;医疗卫生事业;医疗技术学;质量保证;规范(验收);无菌;证实
【英文主题词】:Aseptic;Cleaning;Definitions;Healthservices;Medicaltechnology;Qualityassurance;Specification(approval);Sterility;Validation
【摘要】:ThispartofISO13408specifiesthegeneralrequirementsforclean-in-place(CIP)processesappliedtoproductcontactsurfacesofequipmentusedinthemanufactureofsterilehealthcareproductsbyaseoticprocessingandoffersguidanceonqualification,validation,operationandcontrol.ThispartofISO13408isapplicabletoprocesseswherecleaningagentsarcdeliveredtotheinternalsurfacesofequipmentdesignedtobecompatiblewithCIP,whichmaycomeincontactwiththeproduct.ThispartofISO13408isnotapplicabletoprocesseswhereequipmentisdismantledandcleanedinawasher.ThispartofISO13408doesnotsupersedeorreplacenationalregulatoryrequirements,suchasGoodManufacturingPractices(GMPs)and/orcompendialrequirementsthatpertaintoparticularnationalorregionaljurisdictions.
【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
下载地址: 点击此处下载