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SRPS ISO 13408-3:2010

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

Apr 26, 2010

General information

60.60    

ISS

Z076

European Norm

11.080.01  

English  

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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 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.

93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

NOW

PUBLISHED
SRPS ISO 13408-3:2010
60.60 Standard published

Related project

Adopted from EN ISO 13408-3:2011

Adopted from ISO 13408-3:2006