The Principles of Medical Device Decontamination

5 BS EN ISO 11138-1:2017 - TC Sterilization of health care products. Biological indicators - General requirements Available at https://knowledge.bsigroup.com/products/sterilization-of-health- care-products-biological-indicators-general-requirements

[Accessed 15th Nov 2025]

6 ISO 11138-8:2021 Sterilization of health care products — Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator. Available at https://www.iso.org/standard/62337.html

[Accessed 15th Nov 2025]

7 ISO 11140-1:2014 Sterilization of health care products — Chemical indicators Part 1: General requirements. Available at https://www.iso.org/standard/55080.html

[Accessed 15th Nov 2025]

BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements for 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-moist-heat-requirements-for-the-development-validation-and- routine-control-of-a-sterilization-process-for-medical-devices-2

8

[Accessed 15th Nov 2025] 9 Scottish Health Technical Memorandum 01-01 Decontamination of Medical Devices in a central Decontamination Unit Part E: Sterilization by Hydrogen Peroxide or Ethylene Oxide. Available at https://www.nss.nhs.scot/media/1770/shtm-01-01-part-e-v10- sep-2018.pdf

[Accessed 15th Nov 2025]

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