• 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-12-2023

    Language(s):  English

    Published date:  01-11-2012

    Publisher:  American Society for Testing and Materials

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    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.

    1.5The values are stated in International System of Units (SI units) and English units. Either is to be regarded as standard.

    1.6This 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.

    General Product Information - (Show below) - (Hide below)

    Committee F 02
    Document Type Test Method
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM D 7160 : 2016 Standard Practice for Determination of Expiration Dating for Medical Gloves
    ASTM D 7161 : 2016 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
    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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