1.1 本试验方法设计用于产品开发和生成产品效价数据。本试验方法允许用已知体积的试验生物体装载每个载体。加入对照品还可以确定试验载体上生物体菌落形成单位（CFU）的初始负荷以及接种物强制干燥后CFU的任何损失。 1.2 该测试方法旨在获得幸存者，并与性能标准一起使用。将每个试验载体上存活的微生物与不少于三个对照载体的平均值进行比较，以确定是否满足性能标准。 为了对结果进行适当的统计评估，试验接种物的大小应足够大，以考虑性能标准和结果中的实验变化。例如，如果6-log的任意性能标准 10 使用降低试验生物体活力滴度的方法，接种量为10 7. CFU，则理论上每个承运人最多允许10名幸存者；然而，由于实验的可变性，精确目标可能需要高于10 6. CFU/carrier，因此允许更少的幸存者。 1.3 本试验方法应由受过微生物学培训的人员在设计和配备了适当生物安全水平的传染源工作设施中进行 ( 3. ) . 1.4 在本试验方法中，除距离外，所有应用均使用国际单位制，在这种情况下，使用英寸，然后使用国际单位制。 1.5 研究者有责任确定是否需要良好实验室规范（GLP），并在适当的情况下遵循这些规范（40 CFR第160部分用于EPA提交，21 CFR第58部分用于FDA提交）。 1.6 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。 1.7 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 该测试方法是完全定量的，并且它还避免了通过冲洗而损失任何活生物体，使得与基于最可能数（MPN）的其他定量方法相比，使用更少的测试和控制载体产生统计有效数据成为可能。 5.2 载体的设计使得可以在每个载体中放置精确测量的试验悬浮液体积。使用螺纹搅拌棒可以有效回收接种物，即使在接种物暴露于戊二醛等强固定剂数小时后。 5.3 膜过滤步骤允许处理来自测试载体的整个洗脱液，从而捕获并随后检测可能存在的少量活菌。 5.4 该试验可在有或无土壤负荷的情况下进行，以确定此类负荷对杀微生物剂性能的影响。 在测试之前，咨询目标监管机构关于土壤负荷的需要、类型和可接受水平。一种土壤荷载（定量圆盘载体试验方法 E2197年 )本试验考虑三种类型的蛋白质（高分子量蛋白质、低分子量肽和粘液物质）的混合物，代表化学杀微生物剂在现场条件下可能遇到的身体分泌物、排泄物或其他外来物质。它适用于处理此处包含的各种测试生物体。土壤负荷的成分很容易获得，并且比动物血清的可变性小得多。 5.5 如果产品标签上未指定蒸馏水或其他稀释剂，则假设供试品的稀释剂为自来水。由于自来水的质量在地理和时间上都有很大的差异，因此本试验方法包括使用具有规定和记录硬度水平的水，以制备使用前需要在水中稀释的试验物质稀释液。在测试之前，就水硬度的使用和水平咨询目标监管机构。

1.1 This test method is designed for use in product development and for the generation of product potency data. This test method permits the loading of each carrier with a known volume of the test organism. The incorporation of controls can also determine the initial load of colony forming units (CFU) of organisms on the test carriers and any loss in CFU after the mandatory drying of the inoculum. 1.2 This test method is designed to have survivors and also to be used with a performance standard. The surviving microorganisms on each test carrier are compared to the mean of no less than three control carriers to determine if the performance standard has been met. To allow proper statistical evaluation of results, the size of the test inoculum should be sufficiently large to take into account both the performance standard and the experimental variation in the results. For example, if an arbitrary performance standard of 6-log 10 reduction in the viability titer of the test organism is used, and an inoculum size of 10 7 CFU, then theoretically a maximum of ten survivors per carrier is permitted; however, because of experimental variability, the exact target may need to be higher than 10 6 CFU/carrier, thus fewer survivors would be permitted. 1.3 This test method should be performed by persons with training in microbiology and in facilities designed and equipped for work with infectious agents at the appropriate biosafety level ( 3 ) . 1.4 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow. 1.5 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR Part 160 for EPA submissions and 21 CFR Part 58 for FDA submissions). 1.6 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. 1.7 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 fully quantitative and it also avoids any loss of viable organisms through wash off, making it possible to produce statistically valid data using many fewer test and control carriers than other quantitative methods based on most probable numbers (MPN). 5.2 The design of the carriers makes it possible to place into each a precisely measured volume of the test suspension. The use of the threaded stir bars allows for efficient recovery of the inoculum even after its exposure for several hours to strong fixatives such as glutaraldehyde. 5.3 The membrane filtration step allows processing of the entire eluate from the test carriers and therefore the capture and subsequent detection of even low numbers of viable organisms that may be present. 5.4 This test can be performed with or without a soil load to determine the effect of such loading on microbicide performance. Consult the target regulatory agency on the need, type(s), and acceptable level(s) of soil load prior to testing. One type of soil load (Quantitative Disk Carrier Test Method E2197 ) to consider for this test is a mixture of three types of proteins (high molecular weight proteins, low molecular weight peptides, and mucous material) to represent the body secretions, excretions, or other extraneous substances that chemical microbicides may encounter under field conditions. It is suitable for working with the various test organisms included here. The components of the soil load are readily available and subject to much less variability than animal sera. 5.5 If distilled water or other diluent is not to be specified on the product label, the diluent for the test substance is assumed to be tap water. Since the quality of tap water varies considerably both geographically and temporally, this test method incorporates the use of water with a specified and documented level of hardness to prepare use-dilutions of test substance that require dilution in water before use. Consult the target regulatory agency regarding the use and level of water hardness prior to testing.