RO
SR 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)
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.
Status :
Withdrawn
Approval date : 11/30/2011
Withdrawal date : 3/31/2020
Number of pages : 48
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN 15424:2007
- Normative reference SR EN ISO 11138-5:2007
- Normative reference SR EN 14180:2004
- Normative reference SR EN ISO 11737-1:2006/AC:2009
- Normative reference SR EN ISO 13485:2012/AC:2012
- Normative reference SR EN ISO 13485:2016
- Normative reference SR EN ISO 11737-2:2010
- Normative reference SR EN ISO 11737-1:2006
- Normative reference SR EN ISO 11138-1:2007
- Normative reference SR EN ISO 13485:2012
- Replaced by SR EN ISO 25424:2020