ASTM F 1929 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Hardcopy , PDF
21-12-2023
English
01-11-2012
Committee |
F 02
|
DocumentType |
Test Method
|
Pages |
6
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
1.1This 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 transparent material 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.
1.2Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.
1.3These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.
1.4These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.
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ASTM F 2097 : 2016 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
ISO 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
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