Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

Abstract

5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices. 5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for soil application with clinically relevant, simulated-use test soil (see Guide F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned. 5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil. 5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.