1.1 本试验方法旨在确定医护人员在单次使用和重复使用后，手部摩擦（也称为手摩擦、卫生手摩擦、洗手液或手部防腐剂）对手部瞬时微生物皮肤菌群的活性。 1.2 执行本程序需要了解与人体保护相关的法规（见21 CFR第50和56部分）。 1.3 本试验方法应由受过微生物学培训的人员在设计和配备用于生物安全2级潜在传染源工作的设施中进行。 2. , 3. 1.4 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。 1.5 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。 有关更具体的预防说明，请参阅 8.2 . 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 手部卫生被认为是防止感染性微生物传播的最重要措施之一。不使用肥皂和水，手摩擦可以减少手上的微生物负荷，因此是良好手卫生实践中的重要工具。建议在医疗保健环境中使用含酒精的擦手器，用于没有明显污渍的手。它们的配方是充分用力涂抹在干燥的手上，“摩擦”直到干燥，并且不会被冲洗掉。 5.2 本试验方法专门用于评估手摩擦在消除实验性皮肤细菌方面的效果- 被污染的手。它被设计为测试方法的替代方法 E1174 这项研究的主要目的是评估在水的帮助下起泡然后冲洗掉的抗菌洗手剂。使用测试方法时 E1174 为了评估手摩擦，污染后双手干燥不足会稀释试验材料，并可能影响活动，从而导致低估有效性。此外，由于产品使用后不会冲洗手擦，因此污染肉汤中的土壤和手上的灭活挑战细菌会进一步降解活性。 5.2.1 在这种方法中，应用到手上的体积小，效率高- 滴度测试细菌悬浮液将土壤负荷降至最低，使皮肤在施用测试材料之前完全干燥。此外，通过仅在这些试验材料施用周期之前施用细菌悬浮液，然后进行采样，可以避免杀死的细菌在手上过度积聚，并且可以专门评估非挥发性试验产品成分对连续十次施用后的除菌效果的潜在影响。 5.3 在评估试验材料之前，为每个受试者评估参考对照。来自参考对照组的数据有助于控制受试者之间的可变性，即- 实验可变性和实验室间可变性；并改进了在同一实验中评估的测试材料的统计比较。 5.4 本测试方法可用于测试任何形式的手摩擦，包括凝胶、冲洗液、喷雾、泡沫和湿巾，当按照标签指示以典型的“使用中”剂量使用时。 5.5 不同种类的细菌对杀菌剂的敏感性可能不同，革兰氏阴性菌和革兰氏阳性菌之间存在重大差异。该测试方法提供了使用革兰氏阴性细菌的选项( 粘质沙雷氏菌 )或革兰氏阳性细菌( 金黄色葡萄球菌 )作为测试生物体。 S、 粘质 在两种试验方法中都用作试验生物体 E1174 和试验方法 E2276页 . 金黄色葡萄球菌 在医疗保健、机构和社区环境中是一种高度相关的病原体。此外，手是传递信息的重要工具 金黄色葡萄球菌 人与环境之间，以及个人之间的转移。 5.6 本试验方法可作为试验方法的替代方法 E2276页 ，这将测试细菌限制在指垫上，并且不包括实际使用条件，例如手摩擦时的摩擦。 5.7 研究人员应了解与使用这些生物体相关的潜在健康风险，以及与第节中所述类似的预防措施 8. 应该采取。

1.1 This test method is designed to determine the activity of healthcare personnel hand rubs, (also known as hand rubs, hygienic hand rubs, hand sanitizers, or hand antiseptics) against transient microbial skin flora on the hands after a single application and after repeated applications. 1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56). 1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2. 2 , 3 1.4 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 applicability of regulatory limitations prior to use. For more specific precautionary statements, see 8.2 . 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 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms. Hand rubs reduce the microbial load on the hands without the use of soap and water, and are thus an important tool in the practice of good hand hygiene. Alcohol-based hand rubs are recommended in healthcare settings for use on hands that are not visibly soiled. They are formulated to be applied full strength to dry hands, “rubbed in” until dry, and are not rinsed off. 5.2 This test method is designed specifically to evaluate hand rubs for efficacy in eliminating bacteria from experimentally-contaminated hands. It is designed as an alternative to Test Method E1174 , which was intended primarily to evaluate antimicrobial handwashing agents that are lathered with the aid of water and then rinsed off. When using Test Method E1174 to evaluate hand rubs, inadequate drying of the hands after contamination dilutes the test material and can compromise activity, to result in an underestimation of effectiveness. Additionally, because hand rubs are not rinsed after product use, activity can be further degraded by build-up of soil from the contaminating broth and inactivated challenge bacteria on the hands. 5.2.1 In this method, application to the hands of a small volume of high-titer test bacteria suspension minimizes soil load such that the skin is completely dry prior to application of the test material. Further, by applying the bacterial suspension only prior to those test material application cycles followed by sampling, excessive buildup of killed bacteria on the hands is avoided, and the potential impact of non-volatile test product ingredients on bacteria-eliminating effectiveness after ten consecutive applications can be specifically assessed. 5.3 A reference control is evaluated for each subject prior to evaluation of the test material. Data from the reference control helps to control for inter-subject variability, inter-experimental variability, and inter-laboratory variability; and enables improved statistical comparison of test materials evaluated in the same experiment. 5.4 This test method can be used to test any form of hand rubs, including gels, rinses, sprays, foams, and wipes when used according to label directions at typical “in-use” doses. 5.5 Susceptibility to biocides can vary among different species of bacteria and major differences have been noted between gram-negative and gram-positive organisms. This test method provides the option to use either a gram-negative bacterium ( Serratia marcescens ) or a gram-positive bacterium ( Staphylococcus aureus ) as the test organism. S. marcescens is used as a test organism in both Test Method E1174 and Test Method E2276 . S. aureus is a highly relevant pathogen in healthcare, institutional, and community settings. Moreover, hands are an important vehicle in the transfer of S. aureus between people and the environment, and in the transfer between individuals. 5.6 This test method may be used as an alternative to Test Method E2276 , which limits the test bacteria to the fingerpads and does not incorporate actual use conditions such as friction during hand rubbing. 5.7 The investigator should be aware of potential health risks associated with the use of these organisms and precautions similar to those referenced in Section 8 should be taken.