ASTM WK83703
New Practice for Determining the Antimicrobial Activity of Wound Dressings
1. Scope
This practice describes a quantitative, in vitro assay that can be used to evaluate the antimicrobial activity of absorbent wound dressing materials/products which have been treated with an antimicrobial agent as a means to reduce or inhibit microbial colonization of the wound dressing. Furthermore, this practice assess the sustainability/durability of the antimicrobial activity following a multi-day simulated use conditioning.Keywords
wound dressing; antibacterial; antimicrobial; log reduction; percent reduction; quantitative antimicrobial assayRationale
I have been unable to identify a standard test method or practice that is designed specifically to evaluate the antimicrobial/antibacterial properties of wound dressings. Instead, textile-based methods are currently being used and must be significantly modified to provide appropriate parameters needed to closely simulate the clinical environments these products are used in. These standard methods must also by adapted so that they can demonstrate that the tested samples can substantiate antimicrobial performance claims using criteria often utilized by regulatory agencies in the medical device industry. The above mentioned modifications are considerable, and a new method designed specifically for assessing the antimicrobial/antibacterial properties of wound dressings is needed.
Work Item Status
Date Initiated: 10-08-2022
Technical Contact: Matthew Henry
Item: 002
Ballot: E35.15 (24-02)
Status: Negative Votes Need Resolution