1.1 测试包- 可通过该测试方法进行无损评估的包装包括: 1.1.1 刚性和半刚性无盖托盘。 1.1.2 用多孔屏障盖材料密封的托盘或杯子。 1.1.3 刚性无孔包装。 1.1.4 柔性无孔包装。 1.2 检测到泄漏- 该测试方法通过测量包含测试包件的封闭真空测试室内的压力上升（真空损失）来检测包件泄漏。真空损失是由于测试包顶部空间气体的泄漏和/或位于泄漏处或附近的测试包液体内容物的挥发造成的。当测试可能被包装的液体内容物部分或完全堵塞的泄漏时，测试室被抽空到低于液体蒸发压力的压力。所有方法都需要包含测试包的测试室和设计有一个或多个压力传感器的泄漏检测系统。使用为精密度和偏倚研究选择的特定产品包装系统测定了以下引用的测试方法灵敏度，总结见 表1 . 表1 还列出了可以通过真空衰减测试泄漏的相关产品包装系统的其他示例。 1.2.1 托盘或杯子（无盖）（漏气）- 可以检测托盘/杯壁中直径至少为50 μ m的孔或裂纹缺陷。在-4·E4Pa(-400 mbar)的目标真空下测试无盖托盘。 1.2.2 用多孔屏障封盖材料密封的托盘（顶部空间气体泄漏）- 可以检测托盘/杯壁中直径至少为100 μ m的孔或裂纹缺陷。可以检测到密封区域(使用直径为125 μ m的导线制成)中的通道缺陷。可以检测到连续粘合剂和点阵粘合剂封装系统中的严重密封粘结缺陷。还可以检测到稍微不完全的点阵粘合剂粘合缺陷。在-4·e4Pa(-400毫巴)的目标真空下测试所有多孔屏障盖材料包装。多孔带盖包装的测试灵敏度约为E-2Pa·m 3 ·s -1 使用校准的容积式空气流量计。 1.2.3 刚性无孔包装（顶部空间气体泄漏）- 至少5 μ m的孔洞缺陷可以检测到直径。在-5·e4Pa(-500 mbar)的目标真空下测试具有螺旋盖的塑料瓶。采用校准过的容积式空气流量计，测试的灵敏度约为E-3.4Pa·m 3 ·s -1 在-7.5·E4Pa(+250毫巴绝对值)的目标真空下和再次在约+1毫巴绝对值的目标真空下测试充气玻璃注射器。两种测试的灵敏度约为E-4.1帕·米 3 ·s -1 使用校准的容积式空气流量计。 1.2.4 刚性无孔包装（液体泄漏）- 至少5 μ m的孔洞缺陷可以检测到直径。使用在约+1毫巴绝对值的目标真空下测试的充满水的玻璃注射器群体来验证该检测限。 1.2.5 柔性无孔包装（气体或液体泄漏）- 这种封装也可以通过真空衰变法进行测试。可以检测到直径至少为5µm的孔缺陷是否存在气体泄漏。使用如表11所示的包装群体验证了该检测限。 1.3 测试结果- 测试结果为定性（接受/拒绝）。通过比较从对照无泄漏包装获得的定量基线真空衰减测量值与使用泄漏包装获得的测量值以及使用校准气体流量计引入模拟泄漏获得的测量值来建立验收标准。1.4 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 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》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 5.1 医疗器械、药品和食品包装中的泄漏可能导致有害气体（最常见的是氧气）、有害微生物或颗粒污染物的进入。封装泄漏可能表现为封装组件本身或配合组件之间的密封接合处的缺陷。检测泄漏的能力对于确保包装的一致性和完整性是必要的。 5.2 在初始设置和校准之后，单个测试操作可以是半自动、自动或手动的。该测试方法允许无损检测肉眼无法检测到的泄漏。测试方法不需要引入任何外来材料或物质，如染料或气体。然而，重要的是在测试期间物理掩蔽或阻断任何封装多孔屏障表面，以防止主要由气体通过多孔表面迁移导致的腔室真空的快速损失。泄漏检测仅基于检测测试室内压力变化的能力，该变化是由于气体或蒸汽从受到真空挑战的包装中逸出而导致的。5.3 该测试是优化包装密封参数和比较评估各种包装和材料的有用研究工具。该测试方法也适用于生产设置，因为它是快速、非侵入性和非破坏性的，使其可用于100%在线测试或对生产操作的统计采样进行测试。 5.4 超过真空衰减试验允许限度的泄漏试验结果通过听觉或视觉信号响应或两者来指示。

1.1 Test Packages— Packages that can be nondestructively evaluated by this test method include: 1.1.1 Rigid and semi-rigid non-lidded trays. 1.1.2 Trays or cups sealed with porous barrier lidding material. 1.1.3 Rigid, nonporous packages. 1.1.4 Flexible, nonporous packages. 1.2 Leaks Detected— This test method detects package leaks by measuring the rise in pressure (vacuum loss) in an enclosed evacuated test chamber containing the test package. Vacuum loss results from leakage of test package headspace gases and/or volatilization of test package liquid contents located in or near the leak. When testing for leaks that may be partially or completely plugged with the package’s liquid contents, the test chamber is evacuated to a pressure below the liquid’s vaporization pressure. All methods require a test chamber to contain the test package and a leak detection system designed with one or more pressure transducers. Test method sensitivities cited below were determined using specific product-package systems selected for the precision and bias studies summarized in Table 1 . Table 1 also lists other examples of relevant product-package systems that can be tested for leakage by vacuum decay. 1.2.1 Trays or Cups (Non-lidded) (Air Leakage)— Hole or crack defects in the wall of the tray/cup of at least 50 μm in diameter can be detected. Nonlidded trays were tested at a Target Vacuum of –4·E4 Pa (–400 mbar). 1.2.2 Trays Sealed with Porous Barrier Lidding Material (Headspace Gas Leakage)— Hole or crack defects in the wall of the tray/cup of at least 100 μm in diameter can be detected. Channel defects in the seal area (made using wires of 125 μm in diameter) can be detected. Severe seal bonding defects in both continuous adhesive and dot matrix adhesive package systems can be detected. Slightly incomplete dot matrix adhesive bonding defects can also be detected. All porous barrier lidding material packages were tested at a Target Vacuum of –4·E4 Pa (–400 mbar). The sensitivity of the test for porous lidded packages is approximately E-2 Pa·m 3 ·s -1 using a calibrated volumetric airflow meter. 1.2.3 Rigid, Nonporous Packages (Headspace Gas Leakage)— Hole defects of at least 5 μm in diameter can be detected. Plastic bottles with screw caps were tested at a target vacuum of –5·E4 Pa (–500 mbar). Using a calibrated volumetric airflow meter, the sensitivity of the test is approximately E-3.4 Pa·m 3 ·s -1 . Air-filled glass syringes were tested at a target vacuum of –7.5·E4 Pa (+250 mbar absolute) and again at a target vacuum of about +1 mbar absolute. The sensitivity of both tests is approximately E-4.1 Pa·m 3 ·s -1 using a calibrated volumetric airflow meter. 1.2.4 Rigid, Nonporous Packages (Liquid Leakage)— Hole defects of at least 5 μm in diameter can be detected. This detection limit was verified using a population of water-filled glass syringes tested at a target vacuum of about +1 mbar absolute. 1.2.5 Flexible, Nonporous Packages (Gas or Liquid Leakage)— Such packages may also be tested by the vacuum decay method. Hole defects of at least 5 µm in diameter can be detected for gas leakages. This detection limit was verified using a population of packs as presented in Table 11. 1.3 Test Results— Test results are qualitative (Accept/Reject). Acceptance criteria are established by comparing quantitative baseline vacuum decay measurements obtained from control, non-leaking packages to measurements obtained using leaking packages, and to measurements obtained with the introduction of simulated leaks using a calibrated gas flow meter. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 ====== 5.1 Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages. 5.2 After initial set-up and calibration, individual test operation may be semi-automatic, automatic, or manual. The test method permits non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any package porous barrier surface during the test to prevent rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber resulting from gas or vapor egress from a package challenged with vacuum. 5.3 This test is a useful research tool for optimizing package sealing parameters and for comparatively evaluating various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive, and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation. 5.4 Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.