ISO 13408-5-2006 保健产品的无菌加工.第5部分:现场消毒

sigh007

                   【英文标准名称】:     Aseptic processing of health care products - Part 5: Sterilization in place            【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】:     ISO 13408-5-2006            【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/TC 198【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;Health protection;Health services;Insulators;Medical technologyersonnel;Quality assurance;Specification (approval);Sterility;Surveillance (approval);Training;Validation【摘要】: This part of ISO 13408 specifies the general requirements for sterillization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.   1.2 This part of ISO 13408 applies to processes where sterilizing agent are delivered to the internal surfaces of equipment that can come in contact with the product.  1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer.  1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions.  1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephlopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.【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