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EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) EN ISO 13408-3:2011

Publication date:   Aug 17, 2011

General information

60.60 Standard published   Jun 29, 2011

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

Buying

Published

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Scope

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
93/42/EEC

Medical devices

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

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13824:2004

NOW

PUBLISHED
EN ISO 13408-3:2011
60.60 Standard published
Jun 29, 2011

Relations

Adopted from ISO 13408-3:2006 IDENTICAL