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ASTM D 3078 : 2002 : R2021 : EDT 1

Current

Current

The latest, up-to-date edition.

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-15-2021

1.1This test method covers the determination of gross leaks in flexible packaging containing a headspace gas. Test sensitivity is limited to 1 × 10−5 atm cm3/s (1 × 10−6 Pa m3/s) or even less sensitive as indicated in a recent interlaboratory test (reported in Section 12).

1.2Small leaks may not be detected by this procedure. Viscoelastic effects on the products, or entrapped air, become significant and prevent passage through small openings. Positive pressure inside the pouch after the vacuum is drawn may force the product to plug small leaks. The size of the leak that can be detected is dependent upon the products contained, the nature of the packaging material, and the test parameters selected.

1.3The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.4This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
F 02
DocumentType
Test Method
Pages
3
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM D 6324 : 2011 : R2017 Standard Specification for Male Condoms Made from Polyurethane
ASTM F 2097 : 2020 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM D 4991 : 2007 : R2015 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
ASTM D 7160 : 2016 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM F 2391 : 2005 : R2016 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
ASTM D 6653/D6653M : 2013 Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
ASTM D 3492 : 2016 Standard Specification for Rubber Contraceptives (Male Condoms)
ASTM F 623 : 2019 Standard Performance Specification for Foley Catheter
ASTM D 7161 : 2016 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

ASTM F 98 : 1972 : R1977 : EDT 1 Recommended Practices for Determining Hermeticity of Electron Devices by a Bubble Test
ASTM E 425 : 1990 : REV A Definitions of Terms Related to Leak Testing (Withdrawn 1991)
ASTM E 515 : 2011 : R2022 Standard Practice for Leaks Using Bubble Emission Techniques
ASTM E 515 : 2011 : R2018 Standard Practice for Leaks Using Bubble Emission Techniques

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