1.1 本指南描述了在规定的实验室条件下评估用于清洁医疗器械的刷子部件使用寿命的方法。该方法利用测力仪以恒定速率机械驱动电刷部件。该动作持续到刷子部分显示出清洗能力显著降低（通过测试期间施加的力测量）。 1.2 本指南中使用的测试方法如指南中所述 F3275 和 F3276 . 在本指南中，重复次数是开放式的，由电刷部件的可测量疲劳（通过力的减少测量）以及对电刷部件磨损或损坏的任何观察来确定。 1.3 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。电刷制造商的使用说明应提供与电刷使用寿命有关的信息。 这可以从以下方面说明:( 1. )一段时间；( 2. )使用次数；( 3. )检查电刷是否磨损和损坏。 1.4 磨损检查应始终作为刷子使用说明的一部分。应用本指南有助于确定电刷部件可观察故障的类似模式。 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 本指南介绍了测试方法在指南中的使用 F3275 和 F3276 评估用于清洁医疗器械的刷子部件的使用寿命。 5.2 对于用于清洁内腔的刷子部件，在管内移动刷子部件所需的力（刷子在表面上施加的摩擦力的指示器）是一个可测量的参数，可以随时间变化，并随着刷子部件失去完整性而减小。 5.3 对于用于清洁外表面的电刷部件，在表面上移动电刷所需的力和电刷施加在该表面上的压力是可测量的参数，这些参数可以随时间变化，并随着电刷部件失去完整性而降低。 5.4 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 assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing. 1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276 . In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part. 1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of ( 1 ) a time period; ( 2 ) the number of uses; ( 3 ) inspection of the brush for wear and damage. 1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part. 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 describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device. 5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity. 5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity. 5.4 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.