Cleaning validation of medical devices by ISO 17664

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization.

For cleaning validation more specifically, the testing procedure consists of three steps:

• Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids.

• Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature.

• Inspection, both visually and using quantitative methods relevant to the test soil (e.g. proteins, total organic carbon, or hemoglobin) to assess whether residual contaminants remain on the device.

Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies that we can also offer.

The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.