Historical Version s - view previous versions of standard. More F Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity.
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Active view current version of standard. Other Historical Standards. More F Test Methods F describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F may not reliably detect the weakest area of the seal. By placing the package within restraining plates during pressurization, the dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package, where seals are normally placed.
The burst test is performed by pressurizing the package until the internal pressure causes it to burst. This tests the strength of the seal and records the minimum pressure required for the package to burst. ASTM standards provide for several test methods for burst testing, including dynamic, static, creep, and creep to fail tests. These tests are used to measure the strength of medical device package sterile barrier systems as well as other flexible packaging to determine the weakest points of a package design.