1.1 本试验方法涵盖了评估清洁剂将污染物去除至所需水平的有效性和能力的程序。这包括去除制造设备中的药物残留和医疗器械中的残留（指南 E3106 )以及氧气服务系统。 1.2 本标准中所述的试样/烧杯提供了一个代表性表面，可以在其上施加污染物，并测试清洗剂去除污染物的能力。 1.3 本试验方法是实验室规模的近似方法，特定清洗剂的实际有效性取决于其使用方法（温度、搅拌、浓度等）和被清洗物品的特性，如尺寸、形状和材料。清洗剂的最终评估应包括实际产品和清洗过程的测试。 1.4 单位- 以国际单位制表示的数值应视为标准值。 国际单位制后括号中给出的值仅供参考，不被视为标准值。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任制定适当的安全、健康和环境实践，并根据具体情况确定每种化合物的安全性。 1.6 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 这些测试方法的目的是定义一个程序，用于评估清洁剂从施工材料的替代表面（即试样或烧杯）去除化合物/产品残留物的能力和有效性。 本试验方法还提供了一个程序，用于在开始试验之前确定清洁剂与施工材料的兼容性。根据测试结果，可以选择合适的清洁剂来进一步开发清洁工艺（见指南 D6361/D6361M ). 5.2 也可以使用这些测试来检查与研究中的清洗剂相关的潜在关键清洗参数。潜在的关键清洗参数包括清洗剂浓度、温度、时间、pH值、发泡、超声波能量或搅拌（如使用）的类型和强度等。可以改变这些参数（例如，使用实验设计），以确定其实际使用的潜在最佳设置。

1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents to remove contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical devices (Guide E3106 ), as well as systems for oxygen service. 1.2 The test coupons/beakers described in this standard provide a representative surface to which contamination can be applied and tested for the ability of a cleaning agent to remove it. 1.3 This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent depends upon the method (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products and cleaning processes. 1.4 Units— The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered 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 safety of each compound on a case-by-case basis. 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 The purpose of these test methods is to define a procedure for evaluating the capability and effectiveness of cleaning agents to remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers) of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected for further cleaning process development (see Guide D6361/D6361M ). 5.2 The potential critical cleaning parameters related to the cleaning agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent concentration, temperature, time, pH, foaming, type and strength of ultrasonic energy or agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine their potential optimal settings for actual use.