1.1本试验方法包括检测医疗包装中的严重泄漏。方法灵敏度降至250μm，概率为81%（见第11节）。本试验方法可用于托盘和邮袋包装。 1.2本试验方法的灵敏度尚未评估用于纺粘聚烯烃以外的多孔材料或无孔包装。 1.3本试验方法具有破坏性，因为它需要进入包装以提供内部气压 1.4以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。 1.5 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====== 内部加压试验方法提供了一种实用的方法来检查包装是否存在严重泄漏，这可能导致产品不合格- 不育的 该测试方法在没有常见包装材料/尺寸的测试实验室环境中非常有用。 本试验方法可适用于不适用于任何其他包装完整性试验方法装置的超大或长包装。 该测试方法可作为评估包装完整性的手段。包装完整性对消费者安全至关重要，因为热封包装旨在为产品提供无污染和无菌的环境。

1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 μm with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages. 1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging. 1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== The internal pressurization test method provides a practical way to examine packages for gross leaks, which may render the product non-sterile. This test method is extremely useful in a test laboratory environment where no common package material/size exists. This test method may apply to very large or long packages, which do not fit into any other package integrity test method apparatus. This test method may be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety since heat sealed packages are designed to provide a contamination free and sterile environment to the product.