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ISO 25424:2018

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ISO 25424:2018 is an international standard outlining the requirements for developing, validating, and controlling low-temperature steam and formaldehyde (LTSF) sterilization processes for medical devices. It's applicable to process developers, manufacturers of sterilization equipment, and medical device manufacturers, as well as organizations responsible for medical device sterilization. The standard has been reviewed and confirmed in 2024. 

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