ASTM F2096-01e1
Historical Standard: ASTM F2096-01e1 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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ASTM F2096
1. Scope
1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 m 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
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F17 Terminology Relating to Flexible Barrier Packaging
Keywords
bubble test; internal pressurization; package integrity; Bubble test; Gross leak testing; Internal pressure/testing; Leak testing--packaging applications/containers; Medical/surgical packaging materials; Package integrity test; Porous packaging materials
ICS Code
ICS Number Code 19.060 (Mechanical testing); 55.040 (Packaging materials and accessories)
DOI: 10.1520/F2096-01E01
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