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ISO 13408-1:2008

Aseptic processing of health care products — Part 1: General requirements

Jun 10, 2008
95.99   Withdrawal of Standard   Aug 15, 2023

General information

95.99     Aug 15, 2023

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 13408-1:1998

NOW

WITHDRAWN
ISO 13408-1:2008
95.99 Withdrawal of Standard
Aug 15, 2023

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 13408-1:2008/Amd 1:2013

REVISED BY

PUBLISHED
ISO 13408-1:2023

National adoptions

SRPS ISO 13408-1:2010  
ISS

Aseptic processing of health care products — Part 1: General requirements

95.99   Withdrawal of Standard

Z076 more

SRPS EN ISO 13408-1:2016  
ISS

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

95.99   Withdrawal of Standard

Z076 more