ASTM International - ASTM F1929-98(2004)

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

historical
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Organization: ASTM International
Publication Date: 1 June 2004
Status: historical
Page Count: 3
ICS Code (Packaging materials and accessories): 55.040
significance And Use:

Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks... View More

scope:

1.1 This test method defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 μm (0.002 in.) wire in package edge seals formed between a transparent film and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

1.2 This test method is intended for use on packages with edge seals formed between a transparent film and a porous sheet material. This test method is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal area for a minimum of 20 s. Uncoated papers are especially susceptible to leakage and must be evaluated carefully fro use with this test method.

1.3 This test method requires that the dye penetrant have good contrast to the opaque packaging material.

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.

Document History

October 1, 2015
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a...
November 1, 2012
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar...
ASTM F1929-98(2004)
June 1, 2004
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may...
November 10, 1998
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
1.1 This test method defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a...
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