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Standard Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions 用于确定动态接触条件下抗微生物剂抗菌活性的标准试验方法
发布日期: 2020-09-15
1.1 本试验方法旨在评估经抗菌剂处理的试样在动态接触条件下的抗菌活性。动态摇瓶试验用于常规质量控制和筛选试验,以克服使用经典抗菌试验方法评估基质结合抗菌剂的困难。这些困难包括确保接种物与处理表面接触(如AATCC TM100),在不同接触时间恢复的灵活性,使用不适当的静态条件(如AATCC TM147),灵敏度和再现性。 1.2 该测试方法能够评估许多不同类型的处理基质和广泛的微生物。本试验方法中使用的经处理基质可承受各种物理/化学应力或操作,并允许测试硬水、蛋白质、血液、血清、各种化学品和其他污染物等污染的影响。 1.3 通过比较测试样品和同时运行的对照品的结果来确定表面抗菌活性。 1.4 本试验方法可能不适用于所有类型的经抗菌剂处理的物品或抗菌剂。应根据抗菌剂的作用方式和最终用途预期确定适当的测试方法(指南 E2922 ) 1.5 必须使用测试方法确认所有抗菌剂的正确中和 E1054 . 1.6 本试验方法只能由受过微生物技术培训的人员进行。 1.7 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。 1.8 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。 1.9 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 基质结合的抗菌剂在正常使用条件下通常不能自由扩散到环境中。本试验方法通过在试验期间在激发悬浮液中不断搅拌试样,确保细菌与处理过的纤维、织物或其他基质之间良好接触。 5.2 挑战物种的代谢状态可直接影响特定抗菌剂的有效性或药物浓度的测量。 该物种对特定杀生物剂的敏感性可根据其生命阶段(周期)而改变。在缓冲溶液中接触一小时可导致人群中的代谢停滞。该测试方法标准化了挑战物种的生长条件和基质接触时间,以减少与微生物生长阶段相关的可变性。 5.3 抗菌剂的浸出取决于所使用的测试条件和产品的最终用途。可能需要额外测试以确定化合物是否为基质- 在所有条件下或产品最终使用期间绑定。 5.4 该测试方法无法确定化合物是否浸出到溶液中或固定在基质上。本试验方法仅用于确定本方法后续部分所述的功效。 5.5 当有足够的控制时,该试验适用于评估应力或修改后的试样。 注1: 应力可能包括洗衣、磨损和磨损、辐射和蒸汽灭菌、紫外线暴露、溶剂操作、温度敏感性或类似的物理或化学操作。
1.1 This test method is designed to evaluate the antimicrobial activity of antimicrobial-treated specimens under dynamic contact conditions. This dynamic shake flask test was developed for routine quality control and screening tests in order to overcome difficulties in using classical antimicrobial test methods to evaluate substrate-bound antimicrobials. These difficulties include ensuring contact of inoculum to treated surface (as in AATCC TM100), flexibility of retrieval at different contact times, use of inappropriately applied static conditions (as in AATCC TM147), sensitivity, and reproducibility. 1.2 This test method allows for the ability to evaluate many different types of treated substrates and a wide range of microorganisms. Treated substrates used in this test method can be subjected to a wide variety of physical/chemical stresses or manipulations and allows for the versatility of testing the effect of contamination due to such things as hard water, proteins, blood, serum, various chemicals, and other contaminants. 1.3 Surface antimicrobial activity is determined by comparing results from the test sample to controls run simultaneously. 1.4 This test method may not be appropriate for all types of antimicrobial-treated articles or antimicrobial agents. The proper test methodology should be determined based on antimicrobial mode of action and end-use expectations (Guide E2922 ) 1.5 Proper neutralization of all antimicrobials must be confirmed using Test Methods E1054 . 1.6 This test method should be performed only by those trained in microbiological techniques. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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. 1.9 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 Substrate–bonded, antimicrobial agents are not typically free to diffuse into their environment under normal conditions of use. This test method ensures good contact between the bacteria and the treated fiber, fabric, or other substrate, by constant agitation of the test specimen in a challenge suspension during the test period. 5.2 The metabolic state of the challenge species can directly affect measurements of the effectiveness of particular antimicrobial agents or concentrations of agents. The susceptibility of the species to particular biocides could be altered depending on its life stage (cycle). One-hour contact time in a buffer solution allows for metabolic stasis in the population. This test method standardizes both the growth conditions of the challenge species and substrate contact times to reduce the variability associated with growth phase of the microorganism. 5.3 Leaching of an antimicrobial is dependent upon the test conditions being utilized and the ultimate end use of the product. Additional testing may be required to determine if a compound is substrate-bound in all conditions or during the end use of the product. 5.4 This test method cannot determine if a compound is leaching into solution or is immobilized on the substrate. This test method is only intended to determine efficacy as described in subsequent portions of the method. 5.5 The test is suitable for evaluating stressed or modified specimens, when accompanied by adequate controls. Note 1: Stresses may include laundry, wear and abrasion, radiation and steam sterilization, UV exposure, solvent manipulation, temperature susceptibility, or similar physical or chemical manipulation.
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