Rinsability Test is a great way to help the study sponsor to ensure the remaining level of active ingredient that remains associated with the test surface is not at a level that will be harmful in the following use. This test uses titration analysis to examine the remaining amount of active ingredient that is is left in the rinse water after surface is disinfected.

In the usage of high-level disinfectants, the possibility of contact with these substances is something that needs to be ensured does not occur if the active ingredient could be harmful. To ensure that the level of active ingredient in/on the surface in question is at a level that would not render any ill side effects, the rinse water is tested for the level of active that remains. By showing that the level of active ingredient in the last rinse cycle is low enough to not be harmful, we can assure the surface is sufficiently rinsed to render a safe concentration. This study is conducted simply by collecting the rinse water after the surface has gone through a full cycle of disinfection and the collection is titrated to assess the level of active ingredients remaining. This test is an outstanding way to ensure a sufficient number of rinse cycles occur to render the surface safe for use for the following patient exposure. This test is a conservative approach to exposure that is part of the Premarket Notification 510(k) Submission for Liquid Chemical Sterilants/ High Level Disinfectants.

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