ISO 13408-5:2006 PDF

Scope: 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.

ISO 13408-5:2006 Referenced Document

ISO 11138 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator*， 2021-06-30 Update
ISO 11140 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers*， 2022-11-22 Update
ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results*， 2009-09-01 Update

2006 ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place