1.1 本试验方法规定了评估抗菌导尿管预防或控制生物膜生长能力所需的操作参数。与可重复性试验相比，有效性报告为活菌对数减少 ( 1. ) 2. 大肠杆菌 在人工尿液恒定流动的情况下，在导尿管内腔中生长的生物膜。 1.2 该测试方法用途广泛，也可用于生长和/或表征不同物种的生物膜和悬浮细菌，尽管这需要根据新生物体的生长要求改变操作参数以优化该方法。 1.3 本试验方法可用于评估不含抗菌剂的表面改性导尿管。 1.4 该测试方法描述了如何对活细胞的导管段和流出物进行采样和分析。 生物膜种群密度记录为每表面积的对数菌落形成单位。悬浮细菌种群密度报告为每体积对数菌落形成单位。 1.5 执行本试验方法需要基本微生物学培训。 1.6 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 1.7 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。 1.8 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 在减少医疗器械和植入物相关感染的斗争中，预防表面细菌定植是一项合乎逻辑的战略。细菌在表面的定植是生物膜形成的前兆。生物膜是许多植入物和设备相关感染的病原体，一旦建立，生物膜中的微生物对抗生素治疗的耐受性可以提高1000倍。通常，最好的治疗策略是以高昂的社会经济成本移除植入物或装置。导管相关尿路感染（CAUTI）是最常见的器械相关医疗相关感染。导管相关感染占37% % 在所有医院获得性感染中（HAI）和70 % 在美国所有医院内尿路感染（UTI）中。 S ( 2. , 3. ) . 建立了腔内导管模型（ICM），以评估抗菌导管抑制导管腔内生物膜生长的能力。 5.2 该测试方法的目的是指导用户如何生长、采样和分析 大肠杆菌 人工尿恒定流下导尿管中的生物膜。该测试方法包含了类似公布方法中使用的操作参数 ( 4. ) . 这个 大肠杆菌 生长的生物膜呈斑块状，在导管上各不相同。显微镜下，生物膜是异质的，在某些区域有大簇，在另一些区域有扁平的细胞片甚至单个细胞。到24小时，生物膜在对照导管中形成。如果目标是监测早期生物膜的发展，则需要在24小时样本收集之前收集管道和废水样本。 监测生物膜发展需要采样。腔内导管模型中产生的生物膜适用于抗菌导管和对照导管之间的对比试验。

1.1 This test method specifies the operational parameters required to assess the ability of antimicrobial urinary catheters to prevent or control biofilm growth. Efficacy is reported as the log reduction in viable bacteria when compared to a repeatable ( 1 ) 2 Escherichia coli biofilm grown in the intra-lumen of a urinary catheter under a constant flow of artificial urine. 1.2 The test method is versatile and may also be used for growing and/or characterizing biofilms and suspended bacteria of different species, although this will require changing the operational parameters to optimize the method based upon the growth requirements of the new organism. 1.3 This test method may be used to evaluate surface modified urinary catheters that contain no antimicrobial agent. 1.4 This test method describes how to sample and analyze catheter segments and effluent for viable cells. Biofilm population density is recorded as log colony forming units per surface area. Suspended bacterial population density is reported as log colony forming units per volume. 1.5 Basic microbiology training is required to perform this test method. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard 1.7 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. 1.8 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 In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and device-related infections and once established, microorganisms in biofilm can be up to 1000 times more tolerant to antibiotic therapy. Often the best treatment strategy is removal of the implant or device at a high socioeconomic cost. Catheter associated urinary tract infections (CAUTI) are the most prevalent of the device-related healthcare associated infections. Catheter associated infections account for 37 % of all hospital acquired infections (HAI) and 70 % of all nosocomial urinary tract infections (UTI) in the U.S. ( 2 , 3 ) . The Intraluminal Catheter Model (ICM) was developed to evaluate the ability of antimicrobial catheters to inhibit biofilm growth on the catheter lumen. 5.2 The purpose of this test method is to direct a user in how to grow, sample, and analyze an E. coli biofilm in a urinary catheter under a constant flow of artificial urine. The test method incorporates operational parameters utilized in similar published methods ( 4 ) . The E. coli biofilm that grows has a patchy appearance that varies across the catheter. Microscopically, the biofilm is heterogenous, with large clusters in some areas, and flat sheets of cells or even single cells in others. By 24 h, the biofilm is developed in the control catheters. If the goal is to monitor early stage biofilm development, then tubing and effluent samples need to be collected prior to the 24 h sample collection. Monitoring biofilm development requires sampling. The biofilm generated in the Intraluminal Catheter Model is suitable for comparison testing between antimicrobial and control catheters.