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SRPS EN ISO 13408-1:2024

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

Jul 31, 2024

General information

60.60     Jul 31, 2024

ISS

Z076

European Norm

11.080.01  

English  

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Scope

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

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.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 13408-1:2016

NOW

PUBLISHED
SRPS EN ISO 13408-1:2024
60.60 Standard published
Jul 31, 2024

Related project

Adopted from EN ISO 13408-1:2024

Adopted from ISO 13408-1:2023