ISO 13408-5:2006 医疗保健产品的无菌处理 第5部分：就地灭菌

标准编号：ISO 13408-5:2006

中文名称：医疗保健产品的无菌处理 第5部分：就地灭菌

英文名称：Aseptic processing of health care products — Part 5: Sterilization in place

发布日期：2006-11

标准范围

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.

标准预览图