DIN EN ISO 13408-1:2015-12

This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408. This document (EN ISO 13408-1:2015) has been prepared by the Technical Committee ISO/TC 198 "Sterilization of health care products", in collaboration with Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) with the participation of German experts. The responsible German committee is Working Committee NA 063-01-12 AA "Aseptische Herstellung" ("Aseptic processing") at DIN Standards Committee Medicine (NAMed) at DIN, the German Institute for Standardization e. V. By resolution of the CEN Technical Office (Resolution CEN/BT C50/2015), Annexes ZA, ZB and ZC as well as the European foreword have been updated and published in June 2015 as a new edition EN ISO 13408-1:2015. The result of this new edition of DIN EN ISO 13408-1. The standard contains unchanged ISO 13408-1:2008 including Amendment 1:2013.