5.1 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers.
5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness.
5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface.
5.2 By providing objective, repeatable methods for evaluating performance, under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs
1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance.
1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices.
1.3 Inclusions:
1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another.
1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance.
1.3.3 By use of this guide, 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.
1.4 Exclusions:
1.4.1 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (e.g., stainless steel or other metals) are predicted to be more ......
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