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Norm
ISO 13408-1:2023
Ausgabedatum: 2023 08 15
Aseptic processing of health care products — Part 1: General requirements
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of asepti...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 72 Seiten
Sprache:
Englisch
ICS
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
ISO 13408-1:2023
2023 08 15
Aseptic processing of health care products — Part 1: General requirements
Norm
↖
ISO 13408-1:2008/Amd 1:2013
2013 04 17
Aseptic processing of health care products — Part 1: General requirements — Amendment 1
Norm
ISO 13408-1:2008
2008 06 10
Aseptic processing of health care products — Part 1: General requirements
Norm
ISO 13408-1:1998
1998 07 23
Aseptic processing of health care products — Part 1: General requirements
Norm