The Principles of Medical Device Decontamination

Bioburden and Sterilisation Qualification Testing

Hospitals perform periodic (quarterly or annually) testing for bioburden and sterilisation efficacy (according to the BS EN ISO 11737 4 series) as part of certification activities. Consideration should be given when submitting complex medical devices, some of which are large, to ensure the qualified test service provider has specific experience, protocols and equipment for testing larger devices. It is highly recommended that full discussions should take place prior to purchase to review the cleaning methods and processes as proposed by the manufacturer, and that they are compatible with UK processing parameters and available within the organisation.

References / Sources

1 ISO 17664-1:2021 Processing of healthcare products—information to be provided by the medical device manufacturer for the processing of medical devices Part 1: critical and semi-critical medical devices available at https:// www.iso.org/standard/81720.html

[Accessed 16th Nov 2025]

2 ISO 15883—1:2024 Washer—disinfectors, Part 1: General requirements, terms and definitions and tests, available at https://www.iso.org/ standard/81249.html

[Accessed 16th Nov 2025]

3 ISO 15883-5:2021 Washer-disinfectors, Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy, available at https://www.iso.org/standard/68297.html

[Accessed 16th Nov 2025]

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