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现行 ASTM E2897-22
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Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <emph type="bdit">ex vivo</emph> Porcine Skin 使用离体猪皮肤评估手部卫生局部抗菌产品有效性的标准指南
发布日期: 2022-04-01
1.1 本指南旨在证明使用猪皮作为替代模型的手卫生局部抗菌产品的有效性。 1.2 这些程序需要微生物学技术知识。 1.3 本标准指南可用于评估局部抗菌洗手液或擦手剂配方。 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 本指南可用于证明局部抗菌产品的有效性,使用猪皮作为人体皮肤的替代物,并使用杯擦洗技术进行采样。 5.2 所述技术可用于模拟测试方法 E1174 并将使用猪皮基质克服人类受试者暴露于潜在致病微生物的限制,同时提供适用于试管中无法模拟的各种洗手条件的优势。 5.3 猪皮替代物的使用提供了成本更低、吞吐量更高的筛查。
1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model. 1.2 Knowledge of microbiological techniques is required for these procedures. 1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations. 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 The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling. 5.2 The techniques described can be used to simulate Test Method E1174 and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes. 5.3 Use of the pigskin surrogate offers less expensive and higher throughput screening.
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归口单位: E35.15
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