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ASTM - F2096

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

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

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 and pouch packages.

The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.

This test method is destructive in that it requires entry into the package to supply an internal air pressure

The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Document History

December 15, 2011
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
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 tray...
December 15, 2011
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
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 tray...
April 1, 2004
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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 and...
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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 and...
F2096
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
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 and...
April 10, 2002
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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 and...
April 10, 2001
Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
A description is not available for this item.
April 10, 2001
Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
1. Scope 1.1 This test method covers the detection of gross leaks in porous packages with one package side using Tyvek spunbonded polyolefin. Method sensitivity is down to 250 μm with a 81 %...
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