1.1 本规程中描述的试验旨在评估拟用作急救防腐产品的配方中的抗菌剂是否能够减少或抑制皮肤微生物群的生长，或两者兼有。 1.2 这些程序需要掌握微生物学技术。 1.3 执行此程序需要了解与人体保护相关的法规。（见CFR第50和56部分。） 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 本规程中的程序应用于 体内 皮肤局部用药的抗菌活性评估，旨在帮助预防小切口、擦伤和烧伤感染。 5.1.1 本规程适用于测试含有或浸渍有抗菌剂的液体、软膏、粉末、薄膜或敷料，以确定其减少增强的皮肤菌群的效果或抑制皮肤菌群生长的效果，或两者兼而有之。

1.1 The tests described in this practice are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR Parts 50 and 56.) 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 procedures in this practice should be used for in vivo evaluation of the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns. 5.1.1 This practice is applicable for testing liquids, ointments, powders, films, or dressings, containing or impregnated with an antimicrobial agent, for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.