1.1 本试验方法设计为 体外 定量测定，以评估具有管状几何形状或已用抗微生物剂处理的纱线或纤维的小段样品的抗微生物活性。此外，该方法被设计为相对于未处理的对照样本，提供样本抵抗微生物定殖和随后生物膜形成的能力的定量评估。 1.1.1 从处理的测试样本中回收的浮游微生物种群与从对照测试样本中回收的种群之间的数量差异是抗微生物活性的量度。 1.1.2 经处理的测试样本抵抗生物膜形成的能力的量度是从经处理的测试样本回收的粘附微生物群体与从对照测试样本回收的粘附微生物群体之间的差异。1.2 试验应由受过微生物学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SI单位表示的值将被视为标准值。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。本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)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委员会。 ======意义和用途====== 5.1 尽管目前存在许多用于评估经处理的聚合物和纺织品的抗微生物活性的标准化测试，但这些测试针对容易吸收测试接种物或具有可放置接种物的平坦表面的样品进行了优化，并且它们用于具有管状几何形状的样品或用于少量(小于0.5 g)的纱线或纤维需要对样品进行大量操作。 5.2 为了使这些方法适用于评估管、纤维和纱线样品，需要扭曲管状样品以产生平坦表面或使用不可接受的大量纤维或纱线样品。将具有管状几何形状的测试样本渲染到平坦表面将限制其在测试期间可用于暴露的表面积，并且可能需要解剖样本，这将不可接受地改变其原始状态。使用可用的标准化方法测试经处理的纤维和纱线样品通常需要大量可能无法获得的材料(大于0.5 g)。在这两种情况下，此类操作可能导致误导性结果，其不能反映未修饰样本的抗微生物功效。 5.3 该方法提供了一种环境，其中接种物保持与这些类型的测试样本的表面紧密接触，暴露管状样本的管腔内和管腔外表面两者而无需显著修饰，并且仅需要少量的纤维或纱线来进行测试。 5.4 经典的抗微生物测试方法通常定量暴露于用抗微生物剂处理的样品后存活的微生物的种群或浓度，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 生物膜状态下的细菌的表型行为与它们处于浮游状态时显著不同，特别是在对消毒剂、消毒剂和抗微生物剂的敏感性方面。因此，评估材料表面抵抗细菌定植的能力可能与其对抗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暴露于测试样本后存活的攻击物种的种群，而且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 该测试方法是一种基于批次的系统，其中在存在攻击接种物的情况下，将测试样本暴露于连续的、最小的流体剪切环境中。试验前，应评估该模拟环境相对于试验材料预期最终用途的适当性。 5.6 尽管该方法旨在提供对材料表现出的抗微生物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的初步评估，但这些条件可能不代表样本在其预期最终用途期间可能暴露的所有环境。可以修改本方法中规定的各种测试参数，以在可以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 intraluminal 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.