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EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) EN ISO 13408-1:2015

Publication date:   Sep 16, 2015

General information

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

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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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 13408-1:2011

WITHDRAWN
EN ISO 13408-1:2011/A1:2013

NOW

WITHDRAWN
EN ISO 13408-1:2015
99.60 Withdrawal effective
Apr 24, 2024

REVISED BY

PUBLISHED
EN ISO 13408-1:2024

Relations

Adopted from ISO 13408-1:2008 IDENTICAL

Adopted from ISO 13408-1:2008/Amd 1:2013 IDENTICAL