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DS/EN ISO 25424

Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices

inactive
Organization: DS
Publication Date: 11 July 2011
Status: inactive
Page Count: 58
ICS Code (Sterilization and disinfection in general): 11.080.01
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.

Document History

November 25, 2019
Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical...
DS/EN ISO 25424
July 11, 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 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...
Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 25424:2018)
1.1 Inclusions 1.1.1 This International Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process...
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)
1.1 Inclusions 1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for...
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