• ASTM F 2096 : 2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

    Available format(s):  Hardcopy, PDF

    Superseded date:  19-02-2020

    Language(s):  English

    Published date:  15-12-2011

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 15.10, 2015 Defines the detection of gross leaks in packaging. Method sensitivity is down to 250 [mu]m (0.010 in.) with an 81% probability.

    Scope - (Show below) - (Hide below)

    1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) 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.

    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    Status Superseded
    Superseded By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 F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
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