EN 13726-4 Test Methods for Primary Wound Dressings - Part 4: Compliance

EUROLAB laboratory provides testing and compliance services within the scope of EN 13726-4 standard. This part of the EN 13726 standard defines a test method for measuring the conformity of primary dressings. EN 13726 gives a test method and does not include performance requirements. EN 13726-4 describes test methods for measuring the conformity of primary wound dressings.

Any shape, form, or size of primary dressing material or combination of materials intended to remain in direct contact with the wound is within the scope of this test method.

Primary dressings are used as mechanical barriers for the absorption or delivery of exudates to manage the microenvironment of the wound and can promote primary or secondary wound healing. Devices whose primary purpose is metabolic, pharmacological or immunological interaction are excluded.

The sample is conditioned at (60 ± 15) % RH and (21 ± 2) ºC for at least 16 hours and the test is carried out in the same environment. This test is designed to assess the extensibility and permanent set fit of the primary dressing by measuring its extensibility and permanent set.

When a dressing is applied to a range of motion, for example over a joint, it is important that it allows sufficient freedom of movement underneath the dressing to prevent damage. A dressing that stretches easily and returns close to its original length after lengthening will be more comfortable for the patient to wear. A sticky product that spreads easily enough with the skin helps prevent subcutaneous slip damage. The test is particularly suitable for adhesive dressings, but can also be applied to other dressings that need to move with the skin.

EUROLAB, with its more than 25 years of experience, state-of-the-art accredited laboratories and expert team, helps you get precise and fast results. Do not hesitate to contact our laboratory for your testing and certification requests.