VIII. Validation of Cleaning Process
A. Validation of the Cleaning Process Using Worst-Case Testing
1. Artificial Soil, Inoculation Sites, and Simulated Use
a. Artificial Soil
The manufacturer should select an artificial test soil, the composition of which accurately represents materials that the device would likely be exposed to during an actual clinical use, and would create the greatest (worst-case) challenge to the cleaning process.
b. Inoculation Sites
Soil inoculations should mimic worst-case clinical use conditions. We recommend you use the artificial soil to inoculate the device in all locations likely to contact patient materials, including all locations that are difficult to clean.
c. Simulated Use Conditions
If after clinical use of the device, drying of soil might occur and cleaning might not be performed immediately after use (such as with loaner devices that will be shipped without adequate reprocessing), the validation methods should allow soils to dry for a length of time that simulates worst-case (longest duration).