The evaluation of a wound dressing is dependent on the performance of the materials they’re made from, their microarchitecture and how they’re constructed. To ensure dressings are effective in clinical wound management it is essential that they:
- Resist the mechanical and biochemical wound environment
- Effectively absorb exudate
- Remain in place for the required treatment period
- Easily removed and
- Acceptable to both patients and health care professionals.
In recent years, an acceleration of chronic wound complications has led to the rapid development of advanced wound care therapies with varying compositions and indicators in need of laboratory-based testing that can keep up. Material and physical performance testing is imperative to better evaluate and market wound dressings — which is where the latest EN 13726 updates come into play.
The European Committee for Standardization (CEN) recently published the revised standard EN 13726 – Test methods for wound dressings – Aspects of absorption, moisture vapour transmission, waterproofness and extensibility. The revised standard replaces the previous EN 13726 series of standards published in 2002 and 2003, which covered the test methods for primary wound dressings:
- EN 13726-1:2002 Test methods for wound dressings – Part 1: Absorption methods
- EN 13726-2:2002 Test methods for wound dressings – Part 2: Water vapor permeability of permeable film dressings
- EN 13726-3:2003 Medical devices – Test methods for wound dressings – Part 3: Watertightness
- EN 13726-4:2003 Medical devices – Test methods for wound dressings – Part 4: Formability
This revision acknowledges that several test methods published in the 13726 series needed significant revision to ensure the test results remained appropriate to modern dressing design. Key highlights included in the revised version of EN 1326 are:
- Tests outlined in the revised standard apply to both primary and secondary dressings
- Fluid Retention Capacity and Absorption Under Compression test methods
- Adoption of the Free Swell Absorption method to allow testing of super-absorbent dressings (intact)
- Added parameters for testing foams, hydrocolloids and superabsorbent wound dressing
Currently, the main aim of the revision is to standardize the methods for assessing dressing performance. However, the CEN committee has also mentioned that future revisions will target the performance requirements for different classes of dressings. This is pivotal because it shifts the concept from having a single standardized test method towards diverse customized standard methods for each dressing technology. The use of appropriate test methods supports rapid product development and streamlined routes to regulatory approval.
How can NAMSA help?
NAMSA has extensive experience in wound care testing and can support you as you navigate these recent changes. If your data is based on previous versions, you might be asked to redo it or you may be looking to expand marketing claims through competitor comparisons. Either way, our dedicated team has both the experience and expertise to support your project requirements.
We also offer customizable product-specific services like absorption and sequestration assessments, MVTR, retention assessments, tensile strength, peel strength and time to clot assessments.
Contact our team today to talk about how we can speed your path to regulatory approval and product differentiation.
Stefania Fabbri
Stefania joined NAMSA via the acquisition of Perfectus Biomed in 2022. She has been with Perfectus since 2018 and brings extensive experience in biofilmology. Stefania studied Biomedical Engineering at the University of Genoa before moving to the University of Southampton. Her PhD focused on investigating interfacial instability generation in dental biofilms plus several post-doctoral placements specializing in marine biofilm decontamination.