5.1 This guide provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device.
5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured.
5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured.
5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs.
1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance.
1.2 Inclusions:
1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another.
1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.
1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes.
1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.
1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.
1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to h......
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