Wound dressing test methods (EN 13726)

Wound dressings are applied to open wounds acquired through trauma or surgery to absorb excess wound exudate, and to protect the wound from further mechanical damage and infection. Appropriate testing of different types of wound dressings, including gauzes, hydrogels, films, foam dressings, and hydrocolloid dressings, is required for approval both in the European Union (MDR) and the United States (510(k) submission to the FDA).

The EN 13726 standard contains test methods to assess important characteristics of wound dressings including absorption, moisture transmission rate of permeable film wound and fixation dressings, waterproofness, and extensibility. These methods are conducted in vitro, and involve testing the dressing materials under different physical and chemical parameters.

We are currently offering the following tests under EN 13726:

• Annex B and C - Free swell absorptive capacity and fluid retention

• Annex D - Absorption under compression

• Annex E and O - Fluid handling capacity with air expulsion

• Annex F - Fluid donation of amorphous hydrogel dressings

• Annex G - Dispersion characteristics of gelling dressings

• Annex H and I - Moisture vapor transmission rate of wound dressings

• Annex J - Waterproofness

• Annex K - Extensibility and permanent set