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现行 ASTM E2011-21
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Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand 用整只手进行病毒消除活动的卫生洗手液和搓手液配方评价的标准试验方法
发布日期: 2021-04-01
1.1 本试验方法旨在评估洗手液或擦手剂减少或消除人类手部皮肤中活病毒的能力。 注1: 本试验方法需要病毒学技术知识。 1.2 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。 1.3 本标准可能涉及危险材料、操作和设备。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。 用户应参考实验室安全建议。 ( 3- 5. ) 1.4 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 本试验方法旨在评估实验污染手的卫生洗手液和擦手剂的病毒清除活性。此类制剂可在临床试验中进一步评估其在现场的有效性。本试验方法包括- 手部接触并反映实际使用条件,如手部去污过程中的摩擦,并使替代产品形式,如基于酒精或非酒精的液体、凝胶和泡沫能够根据标签说明进行测试。如果需要的话,其目的是扩展测试方法的测试结果 E1838 它精确地降低了手部有限区域的病毒感染性。当产品形态无法通过试验方法进行试验时,它也可以作为替代试验方法 E1838 . 5.2 本试验方法不适用于外科手擦或术前皮肤准备。 注2: 与仅使用指垫相比,在双手的整个表面应用病毒对受试者的风险更大。 因此,需要更加小心,以确保参与者的手没有任何明显的损伤。此外,在用于此类测试之前,必须彻底筛选病毒制剂,或记录其不含外来或外来病原体。
1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce or eliminate viable viruses from the skin of human hands. Note 1: A knowledge of virological techniques is required for this test method. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard may involve hazardous materials, operations and equipment. 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. The user should consult a reference for laboratory safety recommendations. ( 3- 5 ) 1.4 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 test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and enables alternative product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E1838 , which gives precise reductions in viral infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E1838 . 5.2 This test method is not meant for use with surgical hand scrubs or preoperative skin preparations. Note 2: Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.
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归口单位: E35.15
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