1.1 该实践旨在测量皮肤微生物群落的减少。 1.2 这些程序需要掌握微生物技术知识。 1.3 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.3.1 例外情况- 在这种实践中，公制单位用于除线性测量之外的所有应用，在这种情况下使用英寸，公制单位在括号中。 1.4 执行该程序需要了解与保护人体有关的法规 ( 1. ) . 2. 注1: 重要的是，必须注意的是，美国食品药品监督管理局目前不接受本方法中用于测试批准为血管导管前皮肤制剂的产品的程序产生的数据。 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）。本标准的使用者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》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 这些程序应用于测试局部含抗菌药物的制剂，这些制剂旨在快速有效地立即显著减少完整皮肤上的微生物数量，并且对于术前和血管预软化制剂，在较长时间内保持一定程度的减少。

1.1 The practice is designed to measure the reduction of the microflora of the skin. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3.1 Exception— In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses. 1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects ( 1 ) . 2 Note 1: Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations. 1.5 This standard does not purport to address all of the safety problems, 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 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of microorganisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, maintenance of some degree of reduction for an extended time.