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 help them evaluate the performance of commercially available brushes.

1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals), or other abrasive materials, are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed.

1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested.

1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation.

1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).