ASTM E 3383:2024

1.1 This test method is used to determine the microbial barrier properties of wound dressing. The test is designed to measure the ability of microorganisms to penetrate through a material (wound dressing) under specific conditions. This qualitative in vitro test will demonstrate results such as "Growth" or "No Growth" of the test organism on the agar surface after a specified contact time. 1.2 The test method includes an initial inoculum of 3.0 × 10⁶ ± 2.0 × 10⁶ CFU/mL and a contact time of 24 h to 72 h or per the wound dressing label claim. To show barrier properties, wound dressing should not allow the challenged organism to penetrate and reach the media surface. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriately controlled conditions to ensure the integrity of results and personnel safety. 1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

07.100.10