Standard Test Method for Determining the Microbial Barrier Properties of Wound Dressing – in vitro Wound Model


Importancia y uso:

5.1 An ideal wound dressing absorbs wound exudates, reduces the bioburden within/on the dressing, and protects wounds from microbial penetration through the dressing. Microbial barrier effectiveness testing is performed to measure the ability of microorganisms to penetrate through a material under specific conditions.

5.2 The test may be used for solid wound dressings with or without the addition of antimicrobial agents where the manufacturer is claiming microbial barrier properties in their performance claim. Barriers can be physical (polyurethane) and/or chemical (antimicrobial barrier).

5.2.1 Five (5) commonly used solid wound dressings are (1) hydrogel, (2) hydrocolloid, (3) film, (4) foam, and (5) alginate. Liquid adhesives also protect the wound from being infected by microorganisms. Liquid adhesive dressings contain cyanoacrylate or polyacrylate, which polymerizes quickly to create a solid barrier and protect the wound from contamination.

5.3 This qualitative test method can be used to determine the microbial barrier properties of solid wound dressings including liquid adhesive.

5.3.1 The test represents an in vitro wound model by using a nutrient-rich medium to mimic the wound, the contact time will represent the maximum period of use for a single dressing application on the wound, and an incubation temperature of 37 °C ± 2 °C represents the human body temperature.

5.4 Results are documented as “Growth” or “No Growth.”

5.4.1 No growth underneath the dressing indicates the barrier properties of the wound dressing are effective at preventing microbial penetration through the dressing.

5.4.2 Growth underneath the dressing demonstrates that the challenge organism was able to penetrate the dressing and reach the media surface, indicating that microorganisms can reach the wound by penetrating through the dressing from the outside environment.

Subcomité:

E35.15

Volúmen:

11.08

Palabras clave:

antimicrobial; barrier; colony forming unit; growth indicator;

$ 1,119

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Norma
E3383

Versión
24

Estatus
Active

Clasificación
Test Method

Fecha aprobación
2024-04-01