DIN Standards Committee Health Technologies
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Abstract
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.
Begin
2018-12-17
WI
00204078
Planned document number
DIN EN ISO 13408-1
Project number
06301943
Responsible national committee
NA 176-03-10 AA - Aseptic processing
Responsible european committee
CEN/TC 204 - Sterilization of medical devices
Responsible international committee
ISO/TC 198/WG 9 - Aseptic processing
draft standard
Aseptic processing of health care products - Part 1: General requirements (ISO/DIS 13408-1:2021); German and English version prEN ISO 13408-1:2021
2022-06
Order from DIN Media