Stay Ahead with EN13726:2023 – Testing That Redefines Wound Dressing Standards
The world of wound care is evolving, and so are the standards. The long-awaited revision of the wound dressing standard EN 13726:2023 has been published replacing EN 13726 parts 1-4.
The updated EN13726:2023 introduces rigorous criteria to ensure that dressings provide superior protection, comfort, and safety. Make sure your products are at the forefront with testing that verifies compliance to the latest standards.
Cormica provides comprehensive testing for EN13726:2023, helping you validate that your dressings deliver on performance, durability, and patient-centered care. Here’s how our testing can elevate your wound care products:
- Updated Performance – With EN13726:2023, the standards for fluid absorption, moisture vapor transmission rate, and adherence properties have been strengthened to improve patient outcomes. We offer in-depth testing to meet these enhanced requirements.
- Reputation for Reliability – Compliance with EN13726:2023 is a mark of quality that assures clinicians, healthcare providers, and end-users that your products are tested and trusted to provide safe and effective wound care.
- Increase Market Confidence – In a competitive market, compliance with the newest standards gives your brand a valuable edge, signaling your commitment to the latest advancements in wound care.
6 Key Changes in ISO 80369-20
- Modernised Terminology
Outdated terms such as “Male” and “Female” connectors are being replaced with “Cone” and “Socket.” This update aims to standardise language across industries and foster inclusivity in design discussions. - Expanded Coverage for Reservoir Connectors
The standard now integrates ISO 18250, addressing connectors for reservoir delivery systems. These include applications in respiratory, enteral, neural, intravascular, irrigation, and citrate-based anticoagulant systems, ensuring broader compatibility and safety. - Revised Test for Disconnection by Unscrewing (Annex I)
The test method has shifted from a fixed torque rate of 2 r/min to an “Increasing Unscrewing Torque” approach. The focus is now on measuring the Peak Torque when the connector begins to loosen, rather than the torque at complete detachment. - New Test Method for Air Leakage (Annex K)
Annex K introduces a test for Air Leakage during Aspiration, applying subatmospheric pressure to connectors while the connector-reference connector complex is submerged in water. This crucial addition ensures airtight designs and identifies weak points that could allow leakage. - Updated Environmental Test Conditions
While the test temperature remains unchanged, the allowable relative humidity range has been adjusted from 25–65% RH to 10–70% RH. This change is particularly significant for connectors made of hygroscopic materials, which may behave differently under varying humidity levels. - Enhanced Reporting Requirements
Manufacturers must now include more detailed information in test reports, such as:
• Testing Dates
• Number of Connectors Used
• Preconditioning and Environmental Test Conditions
• Deviations from Test Methods
• Unusual Features Observed
Supporting Your Journey from Concept to Market
Make sure your products meet the highest level of wound care safety and performance. Contact us today to start your EN13726:2023 testing and show your commitment to quality that adapts to the future of healthcare.
Type:
Published:
Author:
Request More Information
Other Cormica News, Events & Resources
Contact Us
Ready to take the next step? We’d love to hear from you. Contact us today to discuss your testing needs and find out how Cormica can help you achieve your goals.