1.1 临床使用后用于清洁医疗器械的刷子在有效的再处理中发挥着重要作用。本指南描述了在规定的实验室条件下表征用于清洁医疗器械内部通道的刷子部件功效的方法。这些方法利用测力仪机械驱动通道内的电刷部件:( 1. )以既定速度测量电刷在通道内移动所需力的方法；( 2. )方法使用相同的测力仪和协议来测量脏污管的土壤去除率，这是另一个性能指标。 1.2 内含物: 1.2.1 本指南描述了在规定的实验室条件下评估刷子部件清洁特性的客观、可量化和可再现的方法，以及模拟医疗器械定义目标区域清洁挑战的测试方法。这也使电刷部件的一种设计与另一种设计的比较成为可能。 1.2.2 在本指南中，电刷部件是指拟在管内移动的部件。 1.2.3 本指南中描述的用于测试的管子为圆柱形，直径均匀。所述试验方法可能不适用于非圆柱管。 1.2.4 通过使用本指南，医疗器械制造商可以描述用于清洁其设备的刷子部分。 1.2.5 通过使用本指南，清洁刷制造商可以评估和表征其刷子在医疗器械目标区域的清洁性能，包括允许与市场上提供的现有刷子零件设计进行比较。此外，他们能够评估可能提高性能的设计和构造修改。 1.2.6 该信息也可以与刷子（医疗器械再加工）的用户共享，以帮助他们评估商用刷子的性能。 1.3 除外责任: 1.3.1 本指南不评估刷子可能造成的潜在损坏。例如，与具有柔性鬃毛（例如，尼龙）或更易弯曲材料的刷子相比，具有刚性鬃毛（例如，不锈钢或其他金属）或其他研磨材料的刷子更有可能损坏医疗设备。应评估更多磨料的潜在损坏。 1.3.2 本指南未规定验收标准，结果将取决于测试的特定参数（例如，测试土壤、干燥时间、通道内径和材料等）。 1.3.3 本指南并非旨在构成对医疗器械的清洁说明进行验证所需的所有步骤，包括为此目的使用刷子，但提供了可能是更广泛协议的一部分的方法，以进行完整的清洁说明验证。 1.3.4 如果刷子用于清洁特定装置，清洁验证应包括使用该装置进行测试。 1.4 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本指南提供了用于评估用于清洁医疗设备内部通道的刷子部件性能特性的测试方法。 5.1.1 在管内移动电刷部件所需的力是电刷施加在表面上的摩擦力的指示器，是清洁效果的参数，应进行测量。 5.1.2 通过在管中移动的刷子部件从管中清除土壤是刷子松动和清除管中土壤有效性的进一步指标，应进行测量。 5.2 通过提供客观、可重复的性能评估方法，本指南可以提高在测试条件下评估各种电刷部件设计的有效性的能力。

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 help them evaluate the performance of commercially available brushes. 1.3 Exclusions: 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). 1.4 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 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.