99.60 Withdrawal effective Apr 24, 2024
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Withdrawn
ISO 13408-1:2008 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.
ISO 13408-1:2008 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.
Legislation related to this standard
WITHDRAWN
EN ISO 13408-1:2015
99.60
Withdrawal effective
Apr 24, 2024
PUBLISHED
EN ISO 13408-1:2024
