ISO-13408-1 › Historical Revision Information
Part 1: General Requirements, Aseptic Processing of Health Care Products -

ISO-13408-1 - 2ND EDITION - SUPERSEDED -- See the following: ISO-13408-1-AM1
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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.

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 13408-1:2008

Revision Level

2ND EDITION

Status

Superseded

Publication Date

June 15, 2008

Committee Number

ISO/TC 198