1.1 本规程旨在评估卫生洗手液和擦手剂降低手部真菌污染水平的能力 ( 3. ) 本规程不适用于外科手部擦洗（试验方法 第115页 )或术前皮肤准备（试验方法 第173页 ). 1.2 执行此程序需要了解与人体实验相关的法规。 3. 1.3 该实践应由经过微生物学培训的人员在设计和配备用于生物安全等级为2级的传染性病原体工作的设施中进行 ( 4. ) . 1.4 单位- 以国际单位制表示的值应视为标准值。本标准不包括其他测量单位。 1.5 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建立适当的安全和健康实践，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《国际标准、指南和建议制定原则决定》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消除实验污染手部真菌污染的能力。由于两个拇指垫和所有八个手指垫可用于任何给定的测试，因此它允许结合输入对照（两个）、接种物干燥后剩余的测试真菌的可培养细胞的对照（两）、用对照或参考溶液处理后消除的真菌细胞（两个，以及最多四次重复以评估所测试制剂的真菌消除效率。 完成一次测试所需的测试真菌悬浮液不超过100µL。 5.2 尽管本规程设计用于真菌，但也有类似的ASTM标准用于病毒检测（试验方法 1838年 )和营养细菌（试验方法 第276页 ). 5.3 洗手后留在手上的可培养微生物水平可以通过用纸、布或热空气干燥洗手来进一步降低 ( 5. ) 因此，未包括在暴露于对照溶液或测试溶液后干燥指垫的步骤，以避免通过干燥过程本身去除真菌。 5.4 该实践并非旨在测试外科手部擦洗或术前皮肤准备。 5.5 接种物干燥后，每个指垫上可培养真菌的污染水平应至少为10 4. CFU，从而允许检测多达4 log 10 在本试验条件下，通过试验制剂降低试验生物体的存活效价。 这本身并不代表产品性能标准，而产品性能标准可能会因管辖权和所评估配方的性质而有所不同。

1.1 This practice is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands ( 3 ) . This practice is not meant for use with surgical hand scrubs (Test Method E1115 ) or preoperative skin preps (Test Method E1173 ). 1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation. 3 1.3 The practice should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 ( 4 ) . 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 and health 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 fungal contamination from experimentally-contaminated hands. 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 culturable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test. 5.2 Whereas this practice is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838 ) and vegetative bacteria (Test Method E2276 ). 5.3 The levels of culturable microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air ( 5 ) . A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid fungal removal by the drying process itself. 5.4 This practice is not designed to test surgical hand scrubs or preoperative skin preps. 5.5 The level of contamination with culturable fungi on each fingerpad after the drying of the inoculum should be at least 10 4 CFU so that it would permit the detection of up to a 4-log 10 reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.