Work Item
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 assay

Rationale

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.

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

Details

Developed by Subcommittee: E35.15

Committee: E35

Staff Manager: Brian Milewski

Work Item Status

Date Initiated: 10-08-2022

Technical Contact: Matthew Henry

Item: 000

Ballot:

Status: