1.1 本指南涵盖了确定以D值表示的死亡率动力学的方法。这些值可以通过构建杀灭曲线（或存活曲线）或使用其他程序确定暴露于抗菌化学品或制剂后的存活人数得出。将介绍计算选项以及浓度系数的计算方法。 1.1.1 试验方法旨在评估配方中的抗菌剂，以定义存活曲线，并随后计算D值。这些测试旨在产生数据和计算值，提供针对单个选定微生物测试的抗菌制剂的杀灭率的基本信息。此外，通过计算浓度指数η，可以使用不同稀释度的抗菌剂暴露的存活曲线计算出的D值来显示稀释的效果( 2. ). D值确定假设理想的一级杀伤反应，反映在计数的直线减少中，其中绘制了计数与时间的关系图。这里的目标不是确定没有发现幸存者的时间，而是确定可用于处理和暴露测定或用于估计稀释度的标准值。 1.1.2 作为杀灭曲线数据潜在用途的一个例子，1994年6月17日出版的FDA，OTC暂定最终专著《医疗保健抗菌药物产品拟议规则》建议使用生存曲线（或杀灭曲线）计算对局部应用的抗菌产品进行测试。本指南中描述的方法适用于这些产品，但可能需要进行调整，例如在搅拌反应混合物时使用消泡剂，以抵消许多配方中存在的洗涤剂。 这些测试的采样通常在接触配方的很短时间间隔后进行，如30秒和60秒。该方法也已应用于更复杂化妆品配方中抗菌成分的防腐测试( 5. ). 1.2 讨论的测试方法只能由受过微生物技术培训的人员执行。 1.3 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。 1.4 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。 1.5 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 设计了不同的程序和方法，用于在微生物暴露于抗菌剂后产生存活数据，以计算在使用其他常用测试方法进行测试时可用于分析和合理化抗菌剂有效性的值。 5.2 这些测试程序中的数据可用于选择和设计其他抗菌剂有效性测试，其中一些测试可能是监管机构为确定特定声明而要求的。关于杀灭率的基本动力学信息通常作为可以建立测试程序的初始信息。

1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient. 1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η ( 2 ). D-value determination assumes the ideal of first-order killing reactions that are reflected in a straight-line reduction in count where a count-versus-time plot is done. The goal here is not to determine the time at which no survivors are found, but to determine a standard value that can be used in processing and exposure determinations or used to estimate dilutions. 1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations ( 5 ). 1.2 The test methods discussed should be performed only by those trained in microbiological techniques. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 different procedures and methods are designed to be used to produce survival data after microorganisms are exposed to antimicrobial agents in order to calculate values that can be used to analyze and rationalize the effectiveness of antimicrobial agents when tested using other, often applied test methods. 5.2 The data from these test procedures may be used in the selection and design of other tests of effectiveness of antimicrobial agents, some of which may be required by regulatory agencies to establish specific claims. Basic kinetic information about killing rate often serves as the initial information on which a testing program can be built.