1.1 本试验方法测定了液体过滤用膜过滤器的细菌截留特性 验证对微生物截留性能 作为挑战生物体。本试验方法可用于评估用于液体灭菌的任何膜过滤系统。 1.2 本试验方法不适用于药品或生物制药灭菌过滤或两者中使用的膜过滤器的细菌保留特性的产品和工艺特定验证。应使用预期产品制造工艺参数和产品溶液或替代物作为载液，进行工艺和产品特定的细菌保留验证。 1.3 以国际单位制表示的数值应视为标准值。 1.3.1 例外情况- 压力单位的英寸-磅值应视为标准值；括号中显示了国际单位转换。 1.4 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。 1.5 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 本试验方法旨在评估标准激发条件下灭菌过滤器的保持性。 5.1.1 10的挑战 7. 每厘米细菌数 2. 选择有效过滤面积，以提供高度保证，即该方法具有足够的灵敏度来检测超大孔隙，并且过滤器将定量保留大量生物体。模型挑战有机体， B、 侏儒 ，被广泛认为是一种小细菌，并被公认为是合格灭菌过滤器的行业标准。就穿透过滤器的能力而言，其他物种可能是最坏的测试。该测试不能保证过滤器能够完全保留此类细菌。 5.1.2 本试验方法中使用的分析程序提供了一种方法，用于为在标准过滤条件下评估的过滤器的过滤效率指定数值。为了保证产品无菌，应进行额外的工艺特定研究。

1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Brevundimonas diminuta as the challenge organism. This test method can be used to evaluate any membrane filter system used for liquid sterilization. 1.2 This test method is not intended to be used in performance of product- and process-specific validation of the bacterial retention characteristics of membrane filters to be used in pharmaceutical or biopharmaceutical sterilizing filtration, or both. Process- and product-specific bacterial retention validation should be carried out using the intended product manufacturing process parameters and the product solution or surrogate as the carrier fluid. 1.3 The values stated in SI units are to be regarded as standard. 1.3.1 Exception— The inch-pound values given for units of pressure are to be regarded as standard; SI unit conversions are shown in parentheses. 1.4 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 This test method is designed to assess the retentivity of a sterilizing filter under standard challenge conditions. 5.1.1 A challenge of 10 7 bacteria per cm 2 of effective filtration area is selected to provide a high degree of assurance that the method has sufficient sensitivity to detect oversized pores and that the filter will quantitatively retain large numbers of organisms. The model challenge organism, B. diminuta , is widely considered to be a small bacterium and is recognized as an industry standard for qualifying sterilizing filters. Other species may represent a worst-case test in terms of ability to penetrate a filter. This test does not provide assurance that filters can completely retain such bacteria. 5.1.2 The analytical procedure utilized in this test method provides a method to assign a numerical value to the filtration efficiency of the filter being evaluated under standard filtration conditions. For the purpose of product sterility assurance, additional process-specific studies should be performed.