1.1 该方法提供了一种无损检测方法，用于检测各种非多孔刚性和半刚性包装中的孔（泄漏）。 1.2 该测试方法通过测量包装在真空测试室内时从包装中提取的质量流量来检测包装泄漏。在测试循环的泄漏测量部分，测试系统是一个封闭系统。封闭系统包括真空储罐、智能分子流量传感器（IMFS）和真空试验箱。从测试包中提取到真空测试室的质量通过IMFS流向真空储罐，以平衡系统。 从真空室到真空储罐的质量流量由IMFS测量。根据质量守恒定律，进入封闭系统的质量流量等于测试包的质量损失。测试系统能够根据要求产生定量（可变数据）或定性（通过/失败）结果。 1.2.1 可在95%置信水平下检测相当于1µm直径玻璃微移液管的顶空气体泄漏缺陷（锐边缺陷）。 1.2.2 对于玻璃瓶和LDPE瓶，可以在95%置信水平下检测到相当于1µm直径玻璃微移液管的液体泄漏缺陷。 对于玻璃注射器，可以检测到相当于直径为2µm的玻璃微移液管的液体泄漏缺陷。 1.3 单位- 以国际单位制表示的数值应视为标准值。压力单位表示为Pa、mbar或Torr。 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 医疗、药品或食品包装中的泄漏会影响产品质量和消费者安全。此类泄漏可能由包装材料中的缺陷或设计用于密封包装的匹配组件之间的缺陷引起。缺陷可能导致有害气体（如氧气或水蒸汽）、颗粒物、液体或微生物污染物进入或流出包装。包装缺陷检测是确保产品质量和消费者安全的关键部分。无菌产品的物理CCI测试方法可用于确保包装无菌性能在运输和产品保质期期间的稳定性。 5.2 质量提取是一种有用的无损检测方法，用于检测各种包装。只要可以设计和制造一个真空试验箱来容纳包装，就可以使用大规模提取来测试包装的形状和尺寸基本上是无限的。 5.3 该方法产生的定量流量测量结果有助于比较包装密封性能、不同批次的产品、材料性能和工艺参数的组合。 5.4 大规模提取的应用范围从手动加载和操作的机器到自动无人值守的工作单元。 该方法可用于审计测试或100%在线测试。 注2: 如果缺陷被固体或非挥发性物质堵塞，则依赖于气体或蒸汽传输的泄漏测试方法（如大量提取）无法检测到缺陷。暴露于环境污染物可能导致堵塞。在某些情况下，包装好的产品本身会堵塞缺陷。例如，泄漏路径可能被悬浮固体、凝胶物质或干燥溶液堵塞。产品堵塞倾向是产品配方、缺陷尺寸和几何形状的函数，可能与产品存储和处理条件以及分配给缺陷暴露的时间有关。 如果要对产品包装单元进行重复泄漏测试，建议调查重复测试条件暴露对缺陷堵塞的影响。堵塞是一种复杂的现象，尚未得到很好的描述或理解。必须注意确保基于通过泄漏路径的气体或蒸汽传输的任何CCI测试方法适用于预期产品。

1.1 This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages. 1.2 This test method detects package leaks by measuring the mass flow extracted from a package while the package is enclosed inside an evacuated test chamber. The test system is a closed system during the leakage measurement portion of the test cycle. The closed system includes a vacuum reservoir, Intelligent Molecular Flow Sensor (IMFS), and vacuum test chamber. Mass extracted from the test package into the vacuum test chamber flows to the vacuum reservoir through the IMFS to equalize the system. Mass flow rate from the vacuum chamber to the vacuum reservoir is measured by the IMFS. Based on the conservation of mass law, mass flow into the closed system is equal to the mass loss from the test package. The test system is capable of producing quantitative (variable data) or qualitative (pass/fail) results depending on the requirements. 1.2.1 Headspace gas leakage defects equivalent to a 1µm diameter glass micropipette (sharp edge defect) can be detected at a 95% confidence level. 1.2.2 Liquid leakage defects equivalent to a 1µm diameter glass micropipette can be detected at a 95% confidence level for glass vials and LDPE bottles. Liquid leakage defects equivalent to a 2 µm diameter glass micropipette can be detected for glass syringes. 1.3 Units— The values stated in SI units are to be regarded as standard. Pressure units are expressed as Pa, mbar, or Torr. 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 Leaks in medical, pharmaceutical, or food product packages can affect product quality and consumer safety. Such leaks can arise from imperfections in package material or between mated components designed to seal the package. Defects can allow unwanted gas (e.g. oxygen or water vapor), particulates, liquids, or microbiological contaminants into or out of the package. Package defect detection can be a critical part of ensuring product quality and consumer safety. Use of a physical CCI test method for sterile products can be used to assure the stability of the package sterility property during transportation and product shelf life. 5.2 Mass extraction is a useful non-destructive test method for testing a wide variety of packages. Package shape and dimensions that can be tested using mass extraction are essentially unlimited, as long as a vacuum test chamber can be designed and manufactured to accommodate the package. 5.3 This method produces quantitative flow measurement results that are useful in comparing package sealing properties, different batches of product, material properties, and combinations of process parameters. 5.4 Applications for mass extraction range from manually loaded and operated machines to automatic unattended work cells. This method can be applied for audit testing or 100% in-line testing. Note 2: Leak test methods that rely on gas or vapor transport, such as mass extraction, are not able to detect defects if they become plugged by solid or nonvolatile matter. Plugging is possible by exposure to environmental contaminants. In some cases, the packaged product itself can clog defects. For example, leak paths may become blocked by suspended solids, gelatinous matter or dried-out solutions. Product clogging propensity is a function of the product formulation, defect size and geometry, and may be linked to product storage and handling conditions as well as the time allotted to defect exposure. An investigation into the impact of repeated test condition exposure on defect plugging is recommended if product-package units are to be subject to repeated leak testing. Clogging is a complex phenomenon that is not well characterized or understood. Care must be taken to ensure that any CCI test method based on gas or vapor transport through the leak path is appropriate for the intended product.