1.1 本试验方法旨在测定卫生洗手液和洗手液的活性 ( 4. ) 抗手部暂时性菌群的药物，不适用于外科手部擦洗或术前皮肤护理。 1.2 执行此程序需要了解与人体保护相关的法规。 3. 1.3 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级传染源工作的设施中进行 ( 5. ) . 1.4 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。 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 体内 该程序旨在测试卫生洗手液或擦手剂清除成年受试者手部实验污染皮肤中选定类型细菌的能力。由于两个指垫和所有八个指垫可用于任何给定的测试，因此允许加入输入控制（两个）、接种物干燥后剩余活菌的控制（两个）、用对照溶液或参比溶液处理后消除的细菌（两个），和多达四个重复，以评估测试产品的除菌效率。完成一次试验所需的试验菌悬液不超过100µL。使用该测试方法的测试结果可构成使用合适的全手测试协议（如测试方法）进行验证性测试的基础 E1174 . 5.2 鉴于该测试方法与细菌测试有关，它可以很容易地适用于原生动物和噬菌体。 真菌工作的类似方法（试验方法 E2613 )和人类来源的病毒（试验方法 E1838 )已经是ASTM标准。 5.3 通过用纸、布或热空气干燥洗手液，可以进一步减少洗手后残留在手上的潜在感染性微生物 ( 7. ) . 因此，不包括暴露于对照溶液或试验溶液后干燥指垫的步骤，以避免干燥过程本身去除细菌。 5.4 本试验方法不适用于外科手擦（试验方法 E1115 )或术前皮肤预处理（试验方法 E1173 ). 5.5 接种物干燥后，每个指垫上活菌的污染水平应比所需的产品性能标准高5到10倍。例如，每个指垫上干燥接种物的滴度应为10左右 5. 当a>10时，测试细菌的菌落形成单位 4. 在本试验方法的条件下，需要减少。

1.1 This test method is designed to determine the activity of hygienic handwash and handrub ( 4 ) agents against transient bacterial flora on hands and is not meant for use with surgical hand scrubs or preoperative skin preps. 1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. 3 1.3 The test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 ( 5 ) . 1.4 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. 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 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate selected types of bacteria from experimentally contaminated skin of the hands of adult subjects. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for viable bacteria remaining after the inoculum has been allowed to dry (two), bacteria eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the bacteria-eliminating efficiency of the product under test. No more than 100 µL of the test bacterial suspension is required to complete one test. The results of testing with this test method may form the basis for confirmatory tests using a suitable whole-hand test protocol, such as Test Method E1174 . 5.2 Whereas this test method relates to testing with bacteria, it can be readily adapted to work with protozoa and bacteriophages. Similar methods for work with fungi (Test Method E2613 ) and viruses of human origin (Test Method E1838 ) are already ASTM standards. 5.3 Potentially infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air ( 7 ) . A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid bacterial removal by the drying process itself. 5.4 This test method is not meant for use with surgical hand scrubs (Test Method E1115 ) or preoperative skin preps (Test Method E1173 ). 5.5 The level of contamination with viable bacteria on each fingerpad after the drying of the inoculum should be five- to ten-fold higher than the product performance criterion required. For example, the titer in the dried inoculum on each fingerpad should be about 10 5 colony forming units of the test bacterium when a >10 4 reduction is required under the conditions of this test method.