1.1 本标准指南提供了在医疗器械制造商提供的使用说明书（IFU）中所述的清洁程序验证过程中，检测和量化可重复使用医疗器械模拟使用测试产生的测试土壤的方法和注意事项。 1.2 所描述的方法用于检测和测量标记物（分析物），这些标记物是最常见的测试土壤中的成分，并且与设备的临床使用相关。不含蛋白质、碳或碳水化合物（例如骨骼）的适当试验土壤将需要其他方法。 1.3 这是一系列ASTM标准指南的一部分，用于验证清洁说明。本系列第一个指南的范围是选择合适的试验土壤（指南 F3208 ). 系列中的第二个（指南 F3293 )描述了用试验土壤接种医疗器械的方法。系列中的第三个（指南 F3321 )描述了提取土壤的方法，用于测量清洁过程执行后医疗器械上的残留土壤。 这是本系列的第四本指南，介绍了检测和量化设备上残留分析物的方法。 1.4 单位-- 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 医疗器械制造商可将本标准指南作为其可重复使用医疗器械清洁说明验证的设计计划和实施的一部分。 5.2 本指南有助于医疗器械制造商确定检测和量化模拟使用试验土壤标记物的适当方法（见指南 F3208 )从而评估医疗设备是否能够被充分清洁。 5.3 本指南介绍了不同分析物的各种测试方法。 5.4 本指南规定了分析物检测方法的验证标准。

1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer. 1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods. 1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208 ). The second in the series (Guide F3293 ) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321 ) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device. 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 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 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208 ), thereby evaluating whether the medical device can be adequately cleaned. 5.3 This guide describes various test methods for the different analytes. 5.4 This guide specifies the validation criteria for analyte detection methods.