EN 13726 Inactive Medical Devices - Test Methods for Primary Wound Dressings

The EN 13726 standard, which is a European standard, consists of the following subsections under the main title of "Inactive medical devices - Test methods for primary dressings":

• EN 13726-1 Part 1: Properties of absorbency
• EN 13726-2 Part 2: Moisture vapor transmission rate of permeable film covers
• EN 13726-3 Part 3: Waterproofing
• EN 13726-4 Part 4: Compliance
• EN 13726-6 Part 6: Odor control

The EN 13726-1 standard defines test methods for evaluating some aspects of the absorbency of primary wound dressings. For the purposes of this standard,

• Alginate dressing refers to dressing containing alginic acid salts that interact with physiological fluids to form gels.
• Amorphous hydrogel refers to a semi-solid gel containing hydrophilic polymers and water.
• The fluid affinity of the dressing refers to its ability to absorb or donate fluid from a simulated wound.
• Fluid carrying capacity refers to the sum of the fluid absorbed through the dressing and the fluid passed.
• The free swelling absorbent capacity is the total absorbent capacity in the presence of excess test fluid and in the absence of any applied load.
• Primary wound dressing refers to any shape, form, or size material or combination of materials intended to remain in direct contact with a wound.

Primary wound dressings are used as mechanical barriers to manage the microenvironment of the wound by absorbing or transmitting body fluids, and can promote wound healing for primary or secondary purposes. Devices with metabolic, pharmacological, or immunological interactions are excluded from the primary purpose. The aim of the test is to evaluate the performance of dressings used in wounds, typically those with moderate to heavy body fluids, where total absorption capacity is a key characteristic. Only dressings that remain physically intact and reach maximum absorption capacity within 30 minutes under test conditions are suitable.

The EN 13726-2 standard describes recommended test methods for evaluating the moisture vapor transmission rate of permeable film primary wound dressings. For the purposes of this standard,

• Moisture vapor transmission rate refers to the permeability of materials against the passage of water molecules to the outside atmosphere from the skin-contacting side under controlled humidity and temperature conditions.
• Permeable dressing refers to a dressing that allows water vapor to pass through the skin or pass through the skin to the outside atmosphere.

Standard EN 13726-3 describes a test method for assessing the waterproofness of primary dressings when such claims are made. This test method provides information about wound dressings that act as a barrier against moisture entering a wound. This test method places water under hydrostatic pressure on the waterproof side of the dressing to determine the amount of water that can penetrate the wound site.

EN 13726-4 standard describes a test method for determining the suitability of primary wound dressings.

Standard EN 13726-6 describes a test method for assessing the waterproofness of primary dressings when such claims are made.

Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides testing services for inactive medical devices and primary wound dressings, within the scope of EN 13726 standard, with its trained and expert staff and advanced technological equipment.