🎯 Purpose of this Update

To ensure product compliance au while maintainingoptimal protection for both medical staff and patients.

👕 Which Products Are Concerned?

EN 13795-2 applies exclusively tosurgical gowns, whether:

• single-use, or

• reusable,

when used as medical devices to prevent the transmission of infectious agents between surgical staff and patients during invasive procedures.

🔧 Key Changes in the 2025 Version

1️⃣ Harmonization with the Medical Device Regulation (MDR)

The standard has moved from a directive-based model to a version fully harmonized with the MDR, making :

• testing methods more precise,

• requirements legally compliant with current regulations.

2️⃣Same Level of Safety for Single-Use and Reusable Gowns

The standard now establishes equivalent performance criteria for both categories.

3️⃣ Enhanced Safety & Traceability

With documentation requirements aligned with the MDR, the 2025 version ensures

• improved traceability,

• stronger regulatory compliance.

4️⃣ Performance-Based Requirements

To encourage technological diversity and innovation,the standard no longer imposes predefined technical features but sets measurable and quantifiable performance criteria.

🔄 . 🔄 Minor Changes Between 2019 and 2025

• Updated to ISO 13938-1: 2019

• Updated from EN 29073-3: 1992 → EN ISO 9073-3: 2023

📌 What This Means for You

This transition ensures that your surgical gowns now meet the strictest European standards for safety, performance, and regulatory compliance.

💡 At TTS, we have already started the transition to the new EN 13795-2:2025 standard.