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Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials 用于测定聚合物或疏水材料中加入的抗微生物剂活性的标准测试方法
发布日期: 2024-04-01
1.1 该测试方法旨在(定量)评估掺入或结合到主要平坦(二维)疏水或聚合物表面或其上的试剂的抗菌效果。该方法主要侧重于评估抗菌活性;然而,其他微生物如酵母和真菌分生孢子也可以使用这种方法进行测试。 1.2 接种物的载体是琼脂浆,它降低了盐水接种物载体的表面张力,并允许形成“伪生物膜”,使接种物与测试表面更均匀地接触。 注1: 该测试方法通过使用琼脂浆基质中的细胞来促进疏水表面的测试。如书面所述,该测试方法不适合确定对生物膜细胞的疗效,生物膜细胞在遗传和代谢方面与本测试中使用的浮游细胞不同。 1.3 该方法可以确认塑料或疏水表面中是否存在抗微生物活性,并允许测定未经处理的塑料或聚合物与结合或掺入低水的塑料或共聚物之间抗微生物活性的定量差异- 可溶性抗微生物剂。还可以对经过防腐剂处理的疏水表面和对照疏水表面上的幸存者数量进行比较。 1.4 该程序还允许确定抗菌处理的“保质期”或长期耐久性,这可以通过在一段时间内测试未洗涤和洗涤的样品来实现。 1.5 这些程序需要具备微生物技术知识。 1.6 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.7 本标准并不旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者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》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 该方法可用于评估掺入/结合的抗菌剂在疏水材料(如塑料、环氧树脂以及其他硬表面)中的有效性。 5.2 水基细菌接种物以“伪生物膜”状态与处理过的材料保持紧密、均匀的接触。测定了在24小时时与从未处理的对照中回收的挑战细菌细胞的存活种群相比的减少百分比。 5.3 疏水性基质可以随着时间的推移重复测试以评估持久的抗微生物活性。
1.1 This test method is designed to evaluate (quantitatively) the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces. The method focuses primarily on assessing antibacterial activity; however, other microorganisms such as yeast and fungal conidia may be tested using this method. 1.2 The vehicle for the inoculum is an agar slurry which reduces the surface tension of the saline inoculum carrier and allows formation of a “pseudo-biofilm,” providing more even contact of the inoculum with the test surface. Note 1: This test method facilitates the testing of hydrophobic surfaces by utilizing cells held in an agar slurry matrix. This test method, as written, is inappropriate to determine efficacy against biofilm cells, which are different both genetically and metabolically than planktonic cells used in this test. 1.3 This method can confirm the presence of antimicrobial activity in plastics or hydrophobic surfaces and allows determination of quantitative differences in antimicrobial activity between untreated plastics or polymers and those with bound or incorporated low water-soluble antimicrobial agents. Comparisons between the numbers of survivors on preservative-treated and control hydrophobic surfaces may also be made. 1.4 The procedure also permits determination of “shelf-life” or long term durability of an antimicrobial treatment which may be achieved through testing both non-washed and washed samples over a time span. 1.5 Knowledge of microbiological techniques is required for these procedures. 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 This method can be used to evaluate effectiveness of incorporated/bound antimicrobials in hydrophobic materials such as plastics, epoxy resins, as well as other hard surfaces. 5.2 The aqueous based bacterial inoculum remains in close, uniform contact in a “pseudo-biofilm” state with the treated material. The percent reduction in the surviving populations of challenge bacterial cells at 24 h versus those recovered from a non-treated control is determined. 5.3 The hydrophobic substrate may be repeatedly tested over time for assessment of persistent antimicrobial activity.
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