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. X3. USING RELATIVE HUMIDITY IN AGING PROTOCOLS X3.1 Aging damage for many materials may be exacerbated in the presence of high or low relative humidity levels. Care should be exercised in using humidity levels, that when combined with temperature produce moisture levels that may not be realistic in nature and may cause unnatural physical changes to materials, (for example, delamination of water based laminates and coextrusions). X3.2 The calculation to estimate time for accelerated aging is based on temperature regardless of the addition of humidity. If the use of humidity or control of humidity is necessary to prevent a material from damage-hydrophobic materials over-drying or moisture sensitive components deteriorating- then relative humidity level ranges at the target temperature should be established based on knowledge of the material, material supplier recommendations or historical information. Limitations to equipment or process used for controlling humidity should also be considered. If use of or control of humidity is not required, this document can provide guidance for temperature range and excursions once a target temperature is determined and used to calculate aging time. X3.3 The inclusion of relative humidity in aging protocols is not intended as an assessment of the impact of humidity on packaging materials. If such an assessment is desired, it should be performed under a separate, non-aging protocol that includes pre-defined humidity extremes


    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:
    Noel Gibbons

    Status:
    Draft Under Development