ASTM International - ASTM F2096-01e1

Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

historical
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Organization: ASTM International
Publication Date: 10 April 2002
Status: historical
Page Count: 5
ICS Code (Mechanical testing): 19.060
ICS Code (Packaging materials and accessories): 55.040
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

Document History

November 1, 2019
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for...
December 15, 2011
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for...
April 1, 2004
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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...
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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...
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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...
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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...
ASTM F2096-01e1
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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...
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