1.1 本指南提供了用于验证清洁说明的可重复使用医疗设备模拟弄脏的方法和注意事项。为了确保医疗器械表面几何形状在最坏情况下受到污染，将描述土壤施用技术以及通过各种方式（例如驱动设备）掺入土壤的技术。 1.2 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。 1.3 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。 1.4 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 本标准指南可供医疗器械制造商用作其设计计划的一部分，并用于验证其可重复使用医疗器械的清洁说明。 5.2 它可以帮助医疗器械制造商确定其设备上最难接近的位置，以便接种临床相关的模拟使用测试土壤（见ASTM） F3208 )，从而允许测试评估医疗器械是否可以充分清洁。 5.3 描述的方法包括移液管、刷洗、浸泡、喷涂、处理和其他施土技术。 5.4 根据对最坏临床条件的评估，给出了如何识别设备与土壤的临床相关区域、土壤干燥的允许时间以及其他调节注意事项的指南。

1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices. 1.2 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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 standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices. 5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208 ), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned. 5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil. 5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.