ASTM WK43444

    Work Item: ASTM WK43444 - Revision of F2097 - 10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

    (What is a Work Item?)

    Active Standard: F2097 - 10

    Developed by Subcommittee: F02.50 | Committee F02 | Contact Staff Manager



    1. Rationale

    Re: F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products The purpose of this ballot is to update F2097 to include new test methods and previously omitted test methods. Methods ASTM D4332, F2622, F2714, F2824, F2825, F3004, F3039, and ISO 10993 have been added to Figure 1, Table 1, and Section 2 Referenced Documents. The Applicability of D3985 has been updated in Table 1 to remove the reference to specific equipment. The Applicability of F1927 has been updated in Table to include a reference to coulometric sensors. The Description for F1929 has been updated in Table 1 to reflect the new techniques The titles of F2227 and F2228 have been updated to reflect the recent update to their titles This ballot is only on the changes/additions to the Guide. Therefore, only those specific areas that have changes, additions, or deletions are shown on the ballot. The actual changes have been noted below in red. Note: on Figure 1, only the subsections that have changes are shown. Please refer to the current active document if you want to verify that a method for which you have particular interest has been included in the Guide.


    Keywords

    Design; Flexible packaging materials; Medical/surgical packaging materials ;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    09-19-2013

    Technical Contact:
    Dhuanne Dodrill

    Item:
    009

    Ballot:
    F02 (14-01)

    Status:
    Ballot Item Approved as F2097-2014 and Pending Publication