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EN ISO 13408-1:2011

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008) EN ISO 13408-1:2011

Publication date:   Aug 17, 2011

General information

99.60 Withdrawal effective   Jun 10, 2015

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
Legislation 98/79/EC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13824:2004

NOW

WITHDRAWN
EN ISO 13408-1:2011
99.60 Withdrawal effective
Jun 10, 2015

CORRIGENDA / AMENDMENTS

WITHDRAWN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

REVISED BY

WITHDRAWN
EN ISO 13408-1:2015

Relations

Adopted from ISO 13408-1:2008 IDENTICAL