ASTM WK45056

    Revision of F1980 - 07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

    (What is a Work Item?)

    Active Standard: F1980 - 07(2011)

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



    WK45056

    1. Rationale

    Clarification and additional guidance for section X3 regarding the use of relative humidity in aging studies.


    Keywords

    accelerated aging; Arrhenius reaction rate; Q10; shelf-life: Accelerated aging/testing--surgical devices/applications; Arrhenius kinetic constants; Medical/surgical packaging materials; Shelf life Q10; Sterile medical device packages; Surgical implants; Testing methods--surgical implants;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    02-12-2014

    Technical Contact:
    Dan Burgess

    Item:
    004

    Ballot:
    F02 (16-01)

    Status:
    Ballot Item Approved as F1980-2016 and Pending Publication