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SSH 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)

Mar 26, 2012
95.99 Withdrawal of Standard   Apr 2, 2020

General information

95.99     Apr 2, 2020

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 15424:2007

NOW

WITHDRAWN
SSH EN ISO 25424:2011
95.99 Withdrawal of Standard
Apr 2, 2020

REVISED BY

PUBLISHED
SSH EN ISO 25424:2019

Related project

Adopted from EN ISO 25424:2011