1.1测试包可通过本测试方法进行无损评估的包包括: 1.1.1刚性和半刚性无盖托盘。 1.1.2用多孔阻隔盖材料密封的托盘或杯子。 1.1.3刚性、无孔包装。 1.1.4灵活、无孔包装（见1.2.4）。 1.2检测到的泄漏-该测试方法能够使用绝对压力或差压传感器泄漏检测器检测包装泄漏。测试灵敏度是传感器灵敏度、封装设计、封装测试夹具设计以及时间和压力的关键测试参数的函数。各种包装系统可能检测到的泄漏类型和尺寸，以及测试灵敏度如下所述。 这些数据基于精度和偏差确认研究。 1.2.1托盘或杯（无盖）-在410的目标真空度下，可以检测到直径至少为50 m的托盘/杯壁上的孔或裂纹缺陷 4. Pa（400 mbar），使用绝对压力传感器测试仪器。 1.2.2用多孔屏障盖材料密封的托盘-可以检测到托盘/杯壁上直径至少为100 m的孔或裂纹缺陷。可以检测到密封区域的通道缺陷（使用直径为125米的导线制成）。在连续粘合剂和点阵粘合剂封装系统中都可以检测到严重的密封粘接缺陷。还可以检测到轻微不完整的点阵式粘合剂粘合缺陷。 在410的目标真空下测试了所有多孔屏障盖材料封装 4. Pa（400 mbar），使用绝对压力传感器测试仪器。使用校准的体积流量计，多孔盖包装的测试灵敏度约为10 -2 Pam公司 3. s -1 . 1.2.3刚性、无孔包装-可检测到直径至少为5 m的孔缺陷。所有刚性无孔封装在510的目标真空下进行测试 4. Pa（500 mbar），使用差压传感器测试仪器。使用经校准的体积流量计，刚性无孔包装的测试灵敏度约为10 -4 Pam公司 3. s -1 . 1.2.4灵活、无孔包装- 也可以使用绝对压力或差压传感器测试仪器，通过真空衰减法对此类包装进行测试。应根据所需的泄漏测试灵敏度选择仪器。精密度和偏差研究中不包括柔性封装的灵敏度数据，尽管使用真空衰减测试此类封装是众所周知的。 1.3测试结果测试结果是定性的（接受/拒绝）。测试结果的验收标准是根据从控制、无泄漏包装中获得的定量基线真空衰减测量值确定的。 1.4标准值单位-本试验方法中使用的值以国际单位制表示，并视为标准单位。 括号中的值仅供参考。 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====== 医疗器械、药品和食品包装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进入。包装泄漏可能表现为包装组件本身或配对组件之间的密封接合处存在缺陷。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。 初始设置和校准后，单个测试的操作可以是半自动、自动或手动。该测试方法允许对无法明显检测到的泄漏进行无损检测。试验方法不要求引入任何外来材料或物质，如染料或气体。然而，重要的是在测试过程中物理屏蔽或阻挡包装的任何多孔屏障表面，以防止主要由气体通过多孔表面迁移引起的腔室真空快速损失。泄漏检测仅基于在真空条件下检测由于空气从适当遮盖的包装中排出而导致的测试室内压力变化的能力。 该测试是一种有用的研究工具，用于优化包装密封参数，并对各种包装和材料进行比较评估。该测试方法也适用于生产环境，因为它是快速、非侵入性和非破坏性的，可用于100%在线测试或对生产操作中的统计抽样进行测试。 超过真空衰减测试允许极限的泄漏测试结果通过声音或视觉信号响应或两者来指示。

1.1 Test PackagesPackages 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 (see 1.2.4). 1.2 Leaks Detected - This test method is capable of detecting package leaks using an absolute or differential pressure transducer leak detector. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the design of the package test fixture, and critical test parameters of time and pressure. Types and sizes of leaks that may be detected for various package systems, as well as test sensitivities are described below. These data are based on precision and bias confirmation studies. 1.2.1 Trays or Cups (Non-lidded) - Hole or crack defects in the wall of the tray/cup of at least 50 m in diameter can be detected at a Target Vacuum of 410 4 Pa (400 mbar) using an absolute pressure transducer test instrument. 1.2.2 Trays Sealed with Porous Barrier Lidding Material - Hole or crack defects in the wall of the tray/cup of at least 100 m in diameter can be detected. Channel defects in the seal area (made using wires of 125 m 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 410 4 Pa (400 mbar) using an absolute pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for porous lidded packages is shown to be approximately 10 -2 Pam 3 s -1 . 1.2.3 Rigid, Nonporous Packages - Hole defects of at least 5 m in diameter can be detected. All rigid, nonporous packages were tested at a target vacuum of 510 4 Pa (500 mbar) using a differential pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for rigid, nonporous packages is shown to be approximately 10 -4 Pam 3 s -1 . 1.2.4 Flexible, Nonporous Packages - Such packages may also be tested by the vacuum decay method using either an absolute or differential pressure tranducer test instrument. The instrument should be selected based on the leak test sensitivity desired. Sensitivity data for flexible packages were not included in the precision and bias studies, although the use of vacuum decay for testing such packages is well known. 1.3 Test ResultsThe test results are qualitative (Accept/Reject). Acceptance criteria for test results are established from quantitative baseline vacuum decay measurements obtained from control, non-leaking packages. 1.4 Standard Value Units - The values used in this test method are stated in SI units and are to be regarded as standard units. Values in parentheses are for information only. 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 ====== 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. After initial set-up and calibration, the operations of individual tests may be semi-automatic, automatic or manual. The test method permits the 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 porous barrier surface of the package during the test to prevent a 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 as a result of air egress from the properly masked package when challenged with vacuum conditions. This test is a useful research tool for optimization of package sealing parameters and for comparative evaluation of 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. Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.