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ISO 25424:2009

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

Publication date:   Aug 14, 2009

95.99 Withdrawal of Standard   Oct 19, 2018

General information

95.99 Withdrawal of Standard   Oct 19, 2018

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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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.

Life cycle

NOW

WITHDRAWN
ISO 25424:2009
95.99 Withdrawal of Standard
Oct 19, 2018

REVISED BY

PUBLISHED
ISO 25424:2018