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This test method will determine the ability of medical device packages to withstand pressure differentials that may occur during sterilization or transportation.

Burst Test method provides a rapid means of evaluating tendencies for medical device package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation. These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package’s life cycle. If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method be exactly the same. Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article.

These test methods do not necessarily provide correlation with actual package seal strength as typically measured using Test Method ASTM F 88 (or equivalent).