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Standard Test Method for Quantitative Performance Evaluation of Antimicrobial Towelettes 抗菌毛巾定量性能评价的标准试验方法
发布日期: 2023-09-01
1.1 该测试方法定量测定了各种尺寸的抗菌丝巾在处理坚硬、无孔表面方面的有效性 铜绿假单胞菌 和 金黄色葡萄球菌 。 1.2 该测试方法可用于评估丝巾对其他微生物的抗菌效果(经过必要的修改)。 1.2.1 该试验方法没有区分试验微生物的化学灭活和从表面机械去除接种物;相反,产品功效被认为是基于丝巾的配方的两个属性的结合。 1.3 该测试方法涉及危险材料、化学品和感染性微生物的使用,因此只能由受过微生物技术培训的人员在设计和配备的设施中进行,该设施应具有适当的生物安全级别,即BSL- 2个或以上实验室;《生物医学和微生物学实验室的生物安全》(BMBL)第6版(BMBL。 1.4 研究人员有责任确定是否需要良好实验室规范(GLP标准——例如,40 CFR,FIFRA第160部分),并在适当时遵循这些规范。 1.5 严格遵守协议对于测试结果的有效性是必要的。 1.6 以国际单位制表示的数值应视为标准。本标准中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 塑料皮氏培养板(载体)提供了一个封闭的系统,用于分析人员对预饱和或浸渍的抗菌丝巾进行计数和简单应用。 5.2 无菌5的Aliquoting % 将非热灭活的胎牛血清(5个10µL斑点)接种到污染的载体上,并将最终试验悬浮液接种到处理过的载体上(5个 µL斑点)使用模板和正位移移液管进行,从而确保精确的接种物水平和土壤和最终测试悬浮液的均匀分布。 5.3 每两个载体组测试一个丝巾,消除了载体之间交叉污染的可能性。 5.4 产品应用的螺旋状圆形运动(从外到内擦拭,使用擦拭模板从内到外擦拭;请参见 附件A3- 附件A6 )确保消毒剂与接种表面的均匀覆盖和接触。 5.5 在接触时间结束时,向处理过的载体中加入中和剂导致测试物质的中和。该标准试验方法提供了进行中和验证的程序,以确认试验物质的杀微生物、抗微生物或两种类型的活性都降低了50 % 在接触时间结束时(请参阅 附件A1 用于中和验证程序)。 5.6 该标准试验方法的设计最大限度地减少了通过载体冲洗而造成的任何活生物体的损失。 5.7 可以选择调整(在PBS中稀释)接种物以达到5.0的所需对照计数 日志 10 CFU/载体至6.5 日志 10 CFU/载体。 5.8 在适用的情况下,包括测试与其他类似程序(如实践)的比较 E1054 和 E2362 。
1.1 This test method quantitatively determines the effectiveness of various sizes of antimicrobial towelettes in treating hard, non-porous surfaces against Pseudomonas aeruginosa and Staphylococcus aureus . 1.2 This test method may be used to evaluate towelettes for antimicrobial efficacy against additional microorganisms (with necessary modifications). 1.2.1 This test method does not differentiate between chemical inactivation of the test microbe and mechanical removal of inoculum from a surface; rather, product efficacy is considered a combination of both attributes of a towelette-based formulation. 1.3 This test method involves the use of hazardous materials, chemicals, and infectious microorganisms and therefore should be performed only by those trained in microbiological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level, a BSL-2 or higher laboratory; specifications provided in the “Biosafety for Biomedical and Microbiological Laboratories” (BMBL), 6th edition (BMBL). 1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP Standards—For example, 40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate. 1.5 Strict adherence to the protocol is necessary for the validity of the test results. 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 The plastic Petri plate (carrier) provides a closed system for enumeration and easy application of a pre-saturated or impregnated antimicrobial towelette by an analyst. 5.2 Aliquoting of sterile 5 % non-heat-inactivated fetal bovine serum (five 10 µL spots) onto soiled carriers and inoculation of final test suspension onto treated carriers (five 10 µL spots) is conducted using a template and a positive displacement pipette, thereby ensuring a precise inoculum level and uniform distribution of soil and final test suspension. 5.3 A single towelette is tested per 2-carrier set, eliminating the likelihood of cross contamination between carriers. 5.4 The corkscrew-patterned circular motion of the product application (wipe outside to inside, wipe inside to outside using the wiping template; see Annex A3 – Annex A6 ) ensures uniform coverage and contact of disinfectant with the inoculated surface. 5.5 The addition of neutralizer to the treated carriers at the end of the contact time results in neutralization of the test substance. This standard test method provides a procedure for performing neutralization verification to confirm that the microbicidal, microbistatic, or both types of activity of a test substance has been reduced by 50 % at the end of the contact time (see Annex A1 for neutralization verification procedure). 5.6 The design of this standard test method minimizes any loss of viable organisms through carrier wash-off. 5.7 It is optional to adjust (dilution in PBS) the inoculum to achieve desired control counts of 5.0 log 10 CFU/carrier to 6.5 log 10 CFU/carrier. 5.8 Include, where applicable, comparisons of the test to other similar procedures such as Practices E1054 and E2362 .
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发布单位或类别: 美国-美国材料与试验协会
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归口单位: E35.15
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