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EN 13824:2004

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements EN 13824:2004

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Jun 29, 2011

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable.
NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

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

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN 13824:2004
99.60 Withdrawal effective
Jun 29, 2011

REVISED BY

PUBLISHED
EN ISO 13408-4:2011

PUBLISHED
EN ISO 13408-3:2011

PUBLISHED
EN ISO 13408-5:2011

WITHDRAWN
EN ISO 13408-6:2011

WITHDRAWN
EN ISO 13408-1:2011

WITHDRAWN
EN ISO 13408-2:2011