ASTM WK65310

    Revision of F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

    (What is a Work Item?)

    Active Standard: F1980 - 16

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



    WK65310


    Keywords

    accelerated aging; Arrhenius reaction rate; Q10; shelf-life;;

    Rationale

    Current revision of the standard includes limited useful guidance on the application of humidity during accelerated aging. Users can follow guidance in the document to dry out the accelerated aging condition, or opt out of humidity controls all together. Goal of this work item is to improve the guidance on how to use humidity during accelerated aging.

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    Work Item Status

    Date Initiated:
    10-08-2018

    Technical Contact:
    Gerald Montgomery

    Item:
    001

    Ballot:
    F02.50 (21-01)

    Status:
    Negative Votes Need Resolution