1.1 本指南提供了从可重复使用医疗器械中提取测试土壤的方法和注意事项，这些可重复使用医疗器械发生在模拟使用验证、临床使用以及器械经过清洗过程后。 1.2 这是验证清洁说明的一系列ASTM指南的一部分。本系列第一个指南的范围是关于选择适当的试验土壤（指南 F3208 ). 系列中的第二个（指南 F3293 )描述了用模拟使用试验土壤接种医疗器械的方法。本系列的第三部分描述了提取试验土壤的方法，以测量在执行清洁程序后残留在医疗器械上的残余土壤。 1.3 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。 1.4 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。 1.5 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 本指南帮助医疗器械制造商确定提取模拟药物的最佳方法- 使用试验土壤（见指南 F3208 )，从而评估医疗器械是否可以充分清洁。 5.3 给出了描述各种土壤提取技术的方法。 5.4 进一步给出了如何验证提取方法的指导。

1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process. 1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208 ). The second in the series (Guide F3293 ) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures. 1.3 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 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 best method(s) for extracting simulated-use test soil (see Guide F3208 ), thereby evaluating whether the medical device can be adequately cleaned. 5.3 Methods describing various techniques for extracting soil are given. 5.4 Guidance is further given as to how to validate the method(s) for extraction.