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

    There was a desire to clarify and provide additional guidance in section X3 for using 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
    Back to Top
    Work Item Status

    Date Initiated:
    02-12-2014

    Technical Contact:
    Patrick Nolan

    Item:
    002

    Ballot:
    F02 (14-02)

    Status:
    Negative Votes Need Resolution