1.1 本试验方法设计为 体外 ，定量分析，以评估已使用抗菌剂处理的管状几何形状或小段纱线或纤维样本的抗菌活性。此外，该方法旨在定量评估样本相对于未处理对照样本抵抗微生物定殖和随后生物膜形成的能力。 1.1.1 从处理过的试样中恢复的浮游微生物种群与从对照试样中恢复的浮游微生物种群之间的数量差异是抗菌活性的度量。 1.1.2 经处理的试样抵抗生物膜形成的能力的测量是从经处理的试样中恢复的粘附微生物种群与从对照试样中恢复的粘附微生物种群之间的差异。 1.2 测试应由受过微生物技术培训的人员在适当控制的条件下进行，以确保结果的完整性和人员安全。 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 本标准可能涉及危险材料、操作和设备。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 虽然目前有许多标准化测试用于评估处理过的聚合物和纺织品的抗菌活性，但这些测试针对易于吸收试验接种物或具有可放置接种物的平面的样本进行了优化，并用于管状几何形状的样本或少量（小于0。 5 g）的纱线或纤维需要对试样进行大量操作。 5.2 为了使这些方法适用于评估管、纤维和纱线样本，需要扭曲管状样本以形成一个平坦的表面，或者使用大量无法接受的纤维或纱线样本。将具有管状几何形状的试样放置在平坦表面将限制其在试验期间可暴露的表面积，并可能需要对试样进行解剖，从而使其偏离其原始状态，这是不可接受的。使用可用的标准化方法测试处理过的纤维和纱线样本通常需要大量可能不可用的材料（大于0.5g）。在这两种情况下，此类操作可能会导致误导性结果，而这些结果并不反映未改性样本的抗菌效果。 5.3 该方法提供了一个接种物与这些类型试样表面保持紧密接触的环境，暴露了内部和外部环境- 和管状试样的管腔外表面，无明显修改，仅需少量纤维或纱线即可进行测试。 5.4 经典的抗菌测试方法通常量化暴露在经抗菌剂处理的样本中存活的微生物的数量或浓度，而不区分存活的微生物是处于浮游状态还是粘附/生物膜状态。 5.4.1 生物膜状态下细菌的表型行为与浮游状态下细菌的表型行为有很大不同，尤其是在对消毒剂、消毒剂和抗菌剂的敏感性方面。因此，评估材料表面抵抗细菌定植的能力可能比其与浮游细菌的功效具有同等或更大的意义。 5.4.2 该方法不仅可以评估在浮游生物暴露于试样后存活的挑战物种的种群，还可以将其与在粘附/生物膜状态下存活的种群进行比较。 5.5 本试验方法是一种基于批次的系统，在该系统中，试样在挑战接种物存在的情况下暴露于连续的最小流体剪切环境中。在测试之前，应评估该模拟环境相对于测试材料预期最终用途的适当性。 5.6 虽然该方法旨在初步评估材料所表现出的抗菌活性及其在非常特定的测试参数下抵抗微生物定植的能力，但这些条件可能并不代表样本在其预期最终使用期间可能暴露在的所有环境中。可以修改该方法中规定的各种测试参数，以在可能更好地模拟最终使用环境的条件下评估材料，但在报告结果时必须清楚地描述该方法的此类更改。

1.1 This test method is designed as an in vitro , quantitative assay to evaluate the antimicrobial activity of specimens with tubular geometries or small segments of yarn or fibers that have been treated with an antimicrobial agent. Further, the method was designed to provide a quantitative assessment of a specimen’s ability to resist microbial colonization and subsequent biofilm formation relative to an untreated control specimen. 1.1.1 The difference in number between the planktonic microbial population recovered from the treated test specimen and the population recovered from the control test specimen is the measure of the antimicrobial activity. 1.1.2 The measure of the ability of the treated test specimen to resist biofilm development is the difference between the adherent microbial population recovered from the treated test specimen and the adherent microbial population recovered from the control test specimen. 1.2 Testing is to be performed by individuals trained in microbiological techniques under appropriately controlled conditions to ensure the integrity of results and personnel safety. 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 may involve hazardous materials, operations, and equipment. 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 Although a number of standardized tests currently exist for assessing the antimicrobial activity of treated polymers and textiles, these are optimized for specimens that readily absorb the test inoculum or that have a flat surface on which the inoculum can be placed, and their use for specimens with tubular geometries or for small quantities (less than 0.5 g) of yarns or fibers requires significant manipulation of the specimen. 5.2 To adapt these methods for evaluating tubes, fiber, and yarn specimens requires distorting tubular specimens to create a flat surface or using unacceptably large quantities of fiber or yarn specimens. Rendering a test specimen having tubular geometry to a flat surface will limit its surface area available for exposure during the test and may require dissection of the specimen, which unacceptably alters it from its original state. Testing of treated fiber and yarn specimens using available standardized methods typically requires large quantities of material (greater than 0.5 g) that may not be available. In both cases, such manipulations may result in misleading results that do not reflect the antimicrobial efficacy of an unmodified specimen. 5.3 This method provides an environment in which the inoculum remains in intimate contact with the surfaces of these types of test specimens, exposing both the intra- and extraluminal surfaces of tubular specimens without significant modification, and requiring only small quantities of fibers or yarns to perform testing. 5.4 Classical antimicrobial test methods generally quantify the population or concentration of microorganisms that survive exposure to specimens treated with an antimicrobial agent without distinguishing whether the surviving microorganisms were in a planktonic or adhered/biofilm state. 5.4.1 The phenotypic behavior of bacteria in the biofilm state differs substantially from when they are in the planktonic state, especially with respect to susceptibility to disinfectants, sanitizers, and antimicrobial agents. Therefore, evaluating the ability of a material’s surface to resist bacterial colonization may be of equal or greater significance than its efficacy versus planktonic bacteria. 5.4.2 This method not only can assess the population of the challenge species that survives planktonic exposure to the test specimen, but also can then compare that to the population that survives in an adherent/biofilm state. 5.5 This test method is a batch-based system in which test specimens are exposed to a continuous, minimal fluid shear environment in the presence of the challenge inoculum. The appropriateness of this simulated environment relative to the intended end-use of the test material should be evaluated prior to testing. 5.6 Although this method is designed to provide an initial assessment of the antimicrobial activity exhibited by a material and its ability to resist microbial colonization under very specific test parameters, these conditions may not be representative of all environments to which the specimen may be exposed during its intended end-use. Various test parameters specified in this method can be modified to evaluate a material under conditions that may better simulate end-use environments, but such alterations of the method must be clearly described when reporting results.