ASTM F2096-02e1
Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

Standard No.

ASTM F2096-02e1

Release Date

2002

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2096-04

Latest

ASTM F2096-11(2019)

Scope

1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 956;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 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.

ASTM F2096-02e1 history

• 2019 ASTM F2096-11(2019) Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• 2011 ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
• 2004 ASTM F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• 2002 ASTM F2096-02e1 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• 2002 ASTM F2096-02 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• 2001 ASTM F2096-01e1 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• 2002 ASTM F2096-01 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)