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SSH EN ISO 13408-1:2011

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

Mar 26, 2012
95.99 Withdrawal of Standard   Mar 30, 2016

General information

95.99     Mar 30, 2016

DPS

DPS/KT 316

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

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN ISO 13408-1:2011
95.99 Withdrawal of Standard
Mar 30, 2016

REVISED BY

PUBLISHED
SSH EN ISO 13408-1:2015

Related project

Adopted from EN ISO 13408-1:2011