DS/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

Standard No.

DS/EN ISO 25424:2011

Release Date

2011

Published By

Danish Standards Foundation

Latest

DS/EN ISO 25424:2011

Replace

DS/EN 15424:2007

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.

DS/EN ISO 25424:2011 history

• 2011 DS/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
• 0000 DS/EN 15424:2007