ASTM WK42720

    New Test Method for Determining the Antimicrobial Activity of Wound Dressings

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    Developed by Subcommittee: E35.15 | Committee E35 | Contact Staff Manager



    WK42720

    1. Scope

    1.1This practice is used to quantitatively evaluate the antimicrobial activity of antimicrobials agents on or within absorbent products containing antibacterial and antimicrobial agents. 1.2This test method should be performed only by those trained in microbiological techniques. 1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    I have been unable to locate an antimicrobial wound dressing method. Textile methods are currently being used and must be heavily modified to provide parameters needed 1) to more closely simulate real-use evaluation 2) to obtain log reduction to parallel and log reduction to initial 3) to demonstrate to the FDA the antimicrobial activity for an antimicrobial claim. Additionally, this method will pull the most scientifically sound parameters from several textile methods together in one comprehensive method. Aanyone adding an antimicrobial agent to an absorbent wound care product must demonstrate in vitro antimicrobial activity / efficacy, including manufacturers of materials and final product, contract laboratories, and secondary vendors submitting for regulatory approval.


    Keywords

    Textiles; quantitative antimicrobial; Log Reduction; Microbial; Bacteria

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    06-27-2013

    Technical Contact:
    Erin Szewczyk

    Status:
    Draft Under Development