The Principles of Medical Device Decontamination

products remain sterile when removed at the end of the cycle. • Ethylene Oxide “Gas” Sterilization is an alternative low temperature sterilization method. It is a gaseous vacuum-based process which includes pre-conditioning, sterilization, and aeration phases. This is not common in the UK healthcare environment due to the lengthy cycle time, the cost, and its potential health and safety hazards.

References / Sources

1 BS EN ISO 14937:2009 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Available at https://knowledge.bsigroup.com/products/sterilization-of-health- care-products-general-requirements-for-characterization-of-a-sterilizing-agent- and-the-development-validation-and-routine-control-of-a-sterilization-process- for-medical-devices

[Accessed 25th Nov 2025]

2 PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Available at https://standardsdevelopment.bsigroup.com/projects/2018-03220

[Accessed 25th Nov 2025]

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