1.1 该测试方法定义了检测和定位泄漏的材料和程序，该泄漏等于或大于透明材料和多孔片材之间形成的50µm（0.002 in.）线包边缘密封形成的通道。将染料渗透剂溶液局部涂抹在密封边缘，以进行泄漏测试。在与染料渗透剂接触指定时间后，对包装进行染料渗透目视检查。 1.2 本试验方法涵盖了三种染料应用方法:注射、边缘浸渍和滴管。 1.3 这些测试方法适用于在透明材料和多孔片材之间形成边缘密封的包装。测试方法仅限于多孔材料，这些材料可以保留染料渗透溶液，并防止其在至少5秒内使密封区域变色。未涂覆的纸张特别容易泄漏，在使用每种测试方法时必须仔细评估。 1.4 这些测试方法要求染料渗透溶液与不透明包装材料具有良好的对比度。 1.5 数值以国际单位制（SI单位）和英语单位表示。两者都应视为标准。 1.6 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建立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。这些泄漏经常出现在相同或不同材料的包装组件之间的密封处。泄漏也可能是由于包装材料中的针孔造成的。 4.2 本试验方法的目的是通过染料泄漏来目测观察通道缺陷的存在。 4.3 此染色渗透程序仅适用于包装密封中的单个泄漏。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，没有达成一致意见。然而，由于这些测试是为了检测泄漏而设计的，因此通常会拒绝出现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现场。它们不是定量的。从这些测试中无法推断出泄漏大小的迹象。这些方法通常被用作合格/不合格测试。 4.6 随着时间的推移，染料溶液将毛细通过任何多孔材料，但通常不会在建议的最长时间内。如果确实发生了芯吸，可以通过观察受试者密封区域的多孔侧来验证。 这种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遵守假阳性的指导。

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.