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EN ISO 25424:2011

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) EN ISO 25424:2011

Publication date:   Aug 17, 2011

General information

99.60 Withdrawal effective   Nov 20, 2019

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN 15424:2007

NOW

WITHDRAWN
EN ISO 25424:2011
99.60 Withdrawal effective
Nov 20, 2019

REVISED BY

PUBLISHED
EN ISO 25424:2019

Relations

Adopted from ISO 25424:2009 IDENTICAL