1.1 本试验方法通过创建1.0μm颗粒的规定气溶胶，并使用单颗粒计数器或双颗粒计数器评估材料的过滤效率，测量多孔包装材料的气溶胶过滤性能。 1.2 本试验方法适用于用于包装最终灭菌医疗器械的多孔材料。 1.3 本试验装置的目的是确定通过材料的流速，在该流速下发生最大渗透。 1.4 以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。 1.5 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。 1.6 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====== 6.1 本试验方法是由Air Dispersion Limited（英国曼彻斯特）进行研究并由Barrier test Consortium Limited资助开发的。这项研究的结果已发表在同行评议的杂志上。 4. 这项研究表明，使用微生物测试多孔包装材料的阻隔性能与测量材料的过滤效率相关。 6.2 本试验方法不需要使用微生物法； 此外，该测试方法可以快速、及时地进行。 6.3 当测量多孔包装材料的过滤效率时，确定了典型的过滤效率曲线（见 图1 ). 由于这些曲线的弧取决于每种材料的特性，因此在材料之间进行比较的适当方法是使用测量材料最大穿透力的参数。 图1 显示渗透作为流速函数的典型曲线 注1: 最大穿透点由指向上的三角形表示。 6.4 颗粒过滤法是一种定量程序，用于确定材料的微生物屏障性能，使用1.0µm颗粒在压差范围内从接近零到约30 cm的水柱（WC）（2942 Pa）。该测试方法基于Tallfull和Sinclair的研究 4. 并使用物理测试方法快速测定微生物屏障性能。

1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters. 1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices. 1.3 The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.5 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. 1.6 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 ====== 6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal. 4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials. 6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner. 6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1 ). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material. FIG. 1 A Typical Curve Showing Penetration as a Function of Flow Rate Note 1: The point of maximum penetration is indicated by the upward pointing triangle. 6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC) (2942 Pa). This test method is based upon the research of Tallentire and Sinclair 4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.