1.1 本规程描述了用于评估清洁剂的单面和双面污染试样的制备程序。适用于评估用于清洁氧气设备、制药设备和医疗器械的清洁剂（见试验方法 G122页 和指南 G127页 ). 它也适用于存在污染问题的其他系统。 1.2 确定了氧气设备、制药设备和医疗设备中最可能发现的几种污染物/残留物。 然而，如果本规程的使用者已识别出这些类别中不包括的污染物，则在适用于本试验方法的情况下，可以用这些已识别的污染物代替试样的制备。 1.3 在制备试样之前，应验证溶剂和清洗剂与非金属基材的兼容性。氧气系统中使用的典型非金属材料包含在指南中 G63 . 1.4 这种做法可能涉及危险材料、操作和设备。 本规程并非旨在解决与其使用相关的所有安全问题。使用本规程的任何人都有责任在使用前咨询并建立适当的安全、健康和环境规程，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 本规程适用于指导表面含有已知量污染物的试样的制备。描述了标准试样，并提供了富氧系统和部件中通常发现的污染物列表。 5.2 这些试样应用于评估富氧系统和部件的清洁剂。这将允许在测试设施内和测试设施之间进行直接比较。 5.3 其他流体处理系统中使用的材料，如氮气、氦气、氢气、汽油等，也可通过本规程进行评估。

1.1 This practice describes the procedure for the preparation of single- and double-sided contaminated test coupons for the evaluation of cleaning agents. It is applicable for the evaluation of cleaning agents proposed for the cleaning of oxygen equipment, pharmaceutical manufacturing equipment, and medical devices (see Test Method G122 and Guide G127 ). It also is applicable to other systems where contamination is a concern. 1.2 Several classes of contaminants/residues most likely to be found in oxygen equipment, pharmaceutical manufacturing equipment, and medical devices are identified. However, if the user of this practice has identified contaminants not included in these classes, such identified contaminants may be substituted for the preparation of the test coupons if appropriate for this test method. 1.3 Solvent and cleaning agent compatibility with nonmetallic substrates should be verified prior to the preparation of the test coupons. Typical nonmetallic materials utilized in oxygen systems are contained in Guide G63 . 1.4 This practice may involve hazardous materials, operations, and equipment. This practice does not purport to address all of the safety concerns associated with its use. It is the responsibility of whomever uses this practice to consult and 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 practice will be suitable to direct the preparation of test coupons with a known amount of contaminant on the surface. A standard test coupon is described and a list of contaminants that have typically been found in oxygen-enriched systems and components is provided. 5.2 These test coupons shall be used in the evaluation of cleaning agents for oxygen-enriched systems and components. This will permit direct comparison within and between test facilities. 5.3 Materials used in other fluid handling systems such as nitrogen, helium, hydrogen, gasoline, etc. may also be prepared for evaluation by this practice.