Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

SRPS ISO 13408-1:2010

Aseptic processing of health care products — Part 1: General requirements

Apr 26, 2010
95.99   Withdrawal of Standard   Oct 31, 2016

General information

95.99     Oct 31, 2016

ISS

Z076

International Standard

11.080.01  

English  

Buying

Withdrawn

Language in which you want to receive the document.

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.

Life cycle

NOW

WITHDRAWN
SRPS ISO 13408-1:2010
95.99 Withdrawal of Standard
Oct 31, 2016

REVISED BY

WITHDRAWN
SRPS EN ISO 13408-1:2014

Related project

Adopted from ISO 13408-1:2008