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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

Notes

Claudia's Notes:
What is a bubble leak test?  You put a packaging or sterile barrier system under water with gently increasing pressurization, looking for evidence of air bubbles.  It is a destructive test, used to confirm that medical packages are providing sterility.

Keywords

bubble test; internal pressurization; package integrity; ICS Number Code 19.060 (Mechanical testing); 55.040 (Packaging materials and accessories)

To find similar documents by ASTM Volume:

15.10 (Packaging; Flexible Barrier Packaging)

To find similar documents by classification:

19.060 (Mechanical testing Including testing equipment Mechanical testing of metals, see 77.040.10)

55.040 (Packaging materials and accessories Including wrappers, paper, films, foils, cords, sealing devices, cushioning, etc. Adhesive tapes for general purposes, see 83.180)

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