1.1 本指南描述了根据土壤特性、设备的物理特性和设备的临床使用选择用于清洁验证的测试土壤的方法。 1.2 本指南描述了一些测试土壤的制备和使用，以验证可重复使用医疗器械的清洁说明。 1.3 可重复使用的医疗设备，如内窥镜、关节镜剃须刀、手术器械和吸引管，在临床使用期间暴露在生物土壤中。准备这些设备以备再次使用需要清洁、消毒和/或灭菌（如适用）。充分清洁是防止污染物转移到下一位患者和医生的过程中的第一步。 如果清除不当，土壤可能会干扰消毒和灭菌过程以及设备的性能。验收标准基于土壤的目视评估或定量指定标记端点或两者（ISO/TS 15883-5，第1节）。清洁后的终点应基于消毒/灭菌的可能干扰、进一步处理期间污染物对患者或医护人员的风险，以及科学文献中确定的清洁终点。 1.4 测试土壤旨在模拟医疗设备在临床使用过程中可能接触到的污染物。 本指南中讨论的测试土壤是一种成分混合物，模拟临床过程中在人类分泌物、血液、组织和骨碎片/刨花以及非患者来源的土壤（例如骨水泥、润滑剂和染料）中常见的成分。测试土壤还模拟医疗器械将接触的临床材料的物理参数（例如粘度、附着力）。 1.5 排除: 1.5.1 本指南不包括验证清洁过程以去除制造残留物的方法 1.5.2 本指南不描述用于验证消毒或灭菌说明的土壤/接种物。 消毒或灭菌验证需要独立于清洁验证研究的单独测试。 1.5.3 所述测试土壤不用于医疗保健设施，以验证其清洁过程的有效性。 1.5.4 测试土壤配方并非旨在涵盖医疗器械可能接触到的每种生物残留物。 1.6 本指南中未描述的测试土壤配方可能与临床相关，并且可能更适合模拟使用测试，具体取决于医疗器械的临床用途。医疗器械制造商有责任科学地确定和证明试验土壤的选择。 1.7 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。 1.8 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。 1.9 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 本指南提供了有关如何选择最能模拟设备临床使用的测试土壤的信息。选择用于验证的测试土壤应与临床相关，并模拟设备/组件在临床过程中会接触到什么。 5.2 本指南将有助于标准化医疗器械制造商在验证可重复使用的医疗器械和再加工设备的清洁程序时使用的测试土壤 5.3 对于与血液接触的设备，模拟测试土壤是基于血液的土壤，如下面所述 7.1.1 - 7.1. 2. . 5.4 对于接触粘液的装置，模拟试验土壤如下所述 7.1.3 . 5.5 对于与患者以外来源的土壤（例如骨水泥）接触的设备，模拟测试土壤应类似于中所述的土壤 7.2 . 这些可以单独使用，也可以与 7.1 . 5.6 可以使用测试土壤的组合（例如，带粘液的血液）来模拟临床污染。例如，在临床使用过程中，柔性内窥镜可能会接触到不同的污染源组合（例如胃肠道、活检血管）。 5.7 任何模拟试验土壤或配方均可用于模拟使用试验，但应由医疗器械制造商进行科学证明。

1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device. 1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices. 1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature. 1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed. 1.5 Exclusion: 1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing 1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies. 1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process. 1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact. 1.6 Test soil formulations not described in this guide may be clinically relevant and may be more appropriate for simulated-use testing depending upon the clinical use of the medical device. The burden is upon the medical device manufacturer to determine and justify scientifically the selection of test soil(s). 1.7 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.8 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. 1.9 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 provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure. 5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment 5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1 - 7.1.2 . 5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3 . 5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2 . These can be used alone or in combination with 7.1 . 5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use. 5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by the medical device manufacturer.