The Principles of Medical Device Decontamination

Terminology and Definitions

Entity of microscopic size, encompassing bacteria, fungi, protozoa, and viruses.

Microorganism

Continual checking, supervising, critically observing, or determining the status, in order to identify change from the performance level required or expected. Device that does not penetrate inside the body, either through a body orifice or through the surface of the body.

Monitoring

Non-invasive device

Microorganisms not thought capable of causing infection.

Non-Pathogenic

Declaration that product is sterile based on records demonstrating that the sterilisation process variable were delivered within specified tolerances.

Parametric release

Porous

Permeable to water, air, or other fluids.

Housing and its direct attachments up to the coupling point connecting it to other equipment, designed and built to contain fluids under pressure. Item providing a defined resistance to a cleaning, disinfection, or sterilisation process and used to access performance of the process.

Pressure vessel

Process Challenge Device (PCD)

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