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SRPS EN ISO 13408-1:2014

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

Apr 30, 2014
95.99   Withdrawal of Standard   Oct 31, 2016

General information

95.99     Oct 31, 2016

ISS

Z076

European Norm

11.080.01  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS ISO 13408-1:2010

NOW

WITHDRAWN
SRPS EN ISO 13408-1:2014
95.99 Withdrawal of Standard
Oct 31, 2016

REVISED BY

WITHDRAWN
SRPS EN ISO 13408-1:2016

Related project

Adopted from EN ISO 13408-1:2011

Adopted from EN ISO 13408-1:2011/A1:2013