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
Withdrawn
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.
Legislation related to this standard
WITHDRAWN
EN 15424:2007
WITHDRAWN
EN ISO 25424:2011
99.60
Withdrawal effective
Nov 20, 2019
PUBLISHED
EN ISO 25424:2019
