1.1 本试验方法定义了检测和定位泄漏等于或大于50µm（0.002 in.）形成通道的材料和程序在透明材料和多孔片材之间形成的封装中的金属丝边缘密封。将染色渗透剂溶液局部涂抹在密封边缘，以测试是否泄漏。在与染料渗透剂接触规定时间后，目视检查包装是否有染料渗透。 1.2 本试验方法涵盖了三种染料应用方法:注射法、边缘浸渍法和滴管法。 1.3 这些测试方法旨在用于在透明材料和多孔板材料之间形成边缘密封的包装。试验方法仅限于多孔材料，这些材料可以保留染料渗透剂溶液，并防止其在至少5秒钟内使密封区域变色。未涂布纸特别容易泄漏，必须仔细评估是否与每种测试方法一起使用。 1.4 这些测试方法要求染料渗透剂溶液与不透明包装材料形成良好对比。 1.5 数值以国际单位制（SI单位）和英制单位表示。任何一种都将被视为标准。 1.6 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和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1 有害的生物或颗粒污染物可能通过泄漏进入医疗包装。在相同或不同材料的包装组件之间的密封处经常发现这些泄漏。包装材料上的针孔也可能导致泄漏。 4.2 本试验方法的目的是通过染料泄漏目视观察通道缺陷的存在。 4.3 该染色渗透程序仅适用于包装密封件中的单个泄漏。在多孔包装材料中发现的一些小泄漏，可以通过其他技术检测到，将不会被指出。 4.4 对于可能对特定包装有害的泄漏水平，没有达成普遍共识。然而，由于这些测试旨在检测泄漏，因此通常拒绝显示任何泄漏迹象的部件。 4.5 这些程序适用于验证和定位泄漏点。它们不是定量的。从这些测试中无法推断泄漏尺寸。这些方法通常用作通过/失败测试。 4.6 染料溶液会随着时间推移通过任何多孔材料，但通常不会在建议的最长时间内。如果发生芯吸，可通过观察主体密封区域的多孔侧来验证。 染料会使材料表面变色。提到 附录X1 有关毛细作用的详细信息和观察假阳性的指导。

1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. 1.2 Three dye application methods are covered in this test method: injection, edge dip, and eyedropper. 1.3 These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method. 1.4 These test methods require that the dye penetrant solution have good contrast to the opaque packaging material. 1.5 The values are stated in International System of Units (SI units) and English units. Either is to be regarded as standard. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material. 4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them. 4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated. 4.4 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. 4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test. 4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.