1.1 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外表面的刷子部件功效的方法。该方法利用测力仪以恒定速率和恒定压力机械驱动表面上的电刷部件。在第一种方法中，测量在表面上驱动所需的力。在下一种方法中，使用相同的测力仪和协议（驱动运动），在受污表面上驱动电刷部件，并测量清除的土壤量，作为性能的另一个指标。 1.2 用于在临床使用后清洁医疗器械的刷子在医疗器械的有效再加工中发挥着重要作用。 1.3 内含物: 1.3.1 本指南描述了在规定的实验室条件下，使用模拟医疗器械定义目标区域清洁挑战的测试方法，评估刷子部件清洁特性的客观、可量化和可再现方法。这也使得可以将一种电刷部件设计与另一种进行比较。 1.3.2 通过使用本指南，清洁刷制造商将能够评估和表征其刷子在医疗器械目标区域的清洁性能，并评估可能提高性能的设计和结构修改。 1.3.3 通过使用本指南，还可以与刷子（医疗器械再加工）的用户共享此信息，以帮助他们评估商用刷子的性能。 1.4 除外责任: 1.4.1 本指南不适用于使用旋转运动清洁医疗设备的刷子。 1.4.2 本指南不评估刷子可能造成的潜在损坏，也不评估刷子在重复使用过程中可能出现的退化。预计硬鬃刷（例如不锈钢或其他金属）比软鬃刷（例如尼龙）更有可能损坏医疗器械；应评估硬鬃刷造成的损坏。评估重复使用将需要比本指南中描述的次数大大增加的测试重复次数。 1.4.3 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、表面积和材料等）。 )经过测试。 1.4.4 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。必须进行单独的医疗器械清洁说明验证研究。 1.5 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。 1.6 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。 1.7 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 本指南提供了两种测试方法，用于评估刷子部件的性能特征，刷子部件旨在通过使用测力仪清洁医疗器械的外表面。 5.1.1 第一种测试方法利用测力仪测量在表面上驱动电刷部件所需的力。这是刷子在表面上施加的摩擦力的指示器，是清洁效果的参数。 5.1.2 第二种试验方法测量了通过表面驱动的刷子部件从表面去除土壤的情况。这是刷子部分松动和清除表面土壤有效性的进一步指标。 5.2 通过提供客观、可重复的方法来评估测试条件下的性能，本指南可以提高评估各种电刷部件设计有效性的能力

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 is not intended to be used for brushes designed to clean medical devices using rotational motion. 1.4.2 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 (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigid-bristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide. 1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested. 1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted. 1.5 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 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