1.1 洗涤剂在临床使用的医疗器械的清洁中发挥着关键作用，但很少有一致的方法来描述这些洗涤剂的关键特性。本指南确定了用于表征其他应用中的洗涤剂的一致标准，ASTM和其他标准，也可用于表征用于清洁临床使用的医疗器械的洗涤剂。 1.2 在确定这些测试方法时，洗涤剂制造商可以参考本指南来描述其洗涤剂的特性。 1.3 通过确定适用的测试方法，可以确定需要开发新的标准化测试方法以表征用于清洁医疗设备的洗涤剂的差距。 1.4 通过确定洗涤剂制造商使用的适用测试方法和报告的结果，可以共享测试结果，并可能在未来制定洗涤剂关键特性的性能标准。 1.5 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。 1.6 除外条款: 1.6.1 本指南不适用于为去除制造过程中产生的残留物而配制的洗涤剂。 1.6.2 本指南不提供可能是洗涤剂配方一部分的消毒剂或消毒剂的相关信息。 1.7 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。 1.8 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 为下一位患者安全使用医疗设备做准备的关键步骤是有效清洁。通常，清洁医疗设备包括在该点进行预清洁- 用于去除临床使用过程中积累的土壤的使用、手动和自动方法。使用的清洁溶液几乎总是用于漂洗的水和洗涤过程中使用洗涤剂的水。AAMI TIR34（同样为EN 285）提供了关于再处理过程中所用水质的指导。本指南参考了各种测试方法，以确保水符合建议的质量。 5.2 在洗涤剂方面，AAMI、ISO、ASTM和FDA文件中几乎没有指南。此外，很少有一致的方法来评估用于清洁医疗器械的洗涤剂。结果是，出于比较的目的，关于洗涤剂的细节知之甚少。 因此，设备制造商在编写使用说明书（IFU）时，用非常通用的术语描述了可用于清洁设备的清洁剂的种类。同样，监管机构在清除再处理指令方面也几乎没有什么可依赖的。最后，最终负责清洁设备的医疗机构几乎没有细节来确保一个品牌的清洁剂与医疗设备制造商在验证测试期间使用的清洁剂大致相同。 5.3 虽然用于清洁医疗设备的清洁剂没有一致的标准测试方法，但用于清洁餐具、洗衣房、地板、台面等的清洁剂有几十种这样的测试方法。 这些方法中的许多都属于ASTM D12:肥皂和包括洗涤剂在内的其他清洁剂的范围。虽然确实存在差异，但基本上用于其他目的的洗涤剂的配方大致相同。在需要的情况下，使用现有的测试方法可以推动洗涤剂配方的开发，或确定对医疗器械清洁新测试方法的需求。

1.1 Detergents play a critical role in the cleaning of clinically-used medical devices, but there are few consensus methods for describing the key characteristics of these detergents. This guide identifies consensus standards, ASTM and others, used to characterize detergents in other applications, which can also be used to characterize detergents used to clean clinically-used medical devices. 1.2 In identifying these test methods, manufacturers of detergents can reference this guide to characterize their detergents. 1.3 By identifying applicable test methods, gaps may be identified where development of new standardized test methods need to be developed to characterize detergents intended to clean medical devices. 1.4 By identifying applicable test methods that are used and results reported by detergent manufacturers, test results can be shared and may lead in the future to development of performance criteria for the key characteristics of detergent. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Exclusions: 1.6.1 This guide is not intended for detergents formulated to remove residues as a result of the manufacturing process. 1.6.2 This guide does not provide information related to disinfection or disinfecting agents that might be part of a detergent formulation. 1.7 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. 1.8 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 A critical step in preparing a medical device for safe use on the next patient is effective cleaning. Typically cleaning a medical device includes precleaning at the point-of-use, manual and automated methods for removing soil that accumulate during clinical use. The cleaning solution(s) used are almost always water for rinsing and water with a detergent during washing. AAMI TIR34 (also EN 285) provides guidance about the quality of water to be used during reprocessing. This guidance references various test methods to ensure that water meets the recommended quality. 5.2 When it comes to detergents very little guidance can be found in AAMI, ISO, ASTM, and FDA documents. Further, there are very few consensus methods for evaluating the detergents intended to clean medical devices. The result is that very little detail about detergents, for comparison purposes, is known. As a result, device manufacturers, when authoring their instructions for use (IFU) describe in very generic terms the kind of detergent that can be used to clean their device. Similarly, regulators, also have very little to rely upon for clearing reprocessing instructions. Finally, the healthcare facility, that is ultimately responsible for getting the device clean, has very little detail to assure that one brand of detergent is roughly equivalent to the one used by the medical device manufacturer during validation testing. 5.3 While consensus standard test methods do not exist for detergents intended to clean medical devices, there are dozens of such test methods when it comes to detergents intended to clean dishes, laundry, floors, countertops, and so forth. Many of these methods are under the domain of ASTM D12: Soaps and other Cleaning Agents Including Detergents. While differences certainly do exist, essentially the detergents used for the other purposes are roughly formulated in the same way. Using existing test methods can drive detergent formulation development or determine the need for new test methods for medical device cleaning, where or if needed.