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About This Item

 

Full Description

This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.

NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.

All current amendments available at time of purchase are included with the purchase of this document.

 

Document History

  1. BS EN ISO 25424:2019+A1:2022

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    Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Most Recent
  2. BS EN ISO 25424:2019


    Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  3. BS 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

    • Historical Version
  4. BS EN 15424:2007


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

    • Historical Version