During medical procedures, safety must always be guaranteed. For this reason, standards are frequently updated to keep patients’ lives protected. Recently, important changes have been introduced with the specific goal of safeguarding patient safety and improving the efficiency of medical procedures.
In this context, the European Union has worked to strengthen the regulatory framework for medical devices, including surgical clothing, medical face masks, and sterilization processes. In fact, this update is quite recent: on October 17, 2025, the European Commission adopted a series of modifications to harmonized standards through Implementing Decision 2025/2078.
If you work in the medical field in an EU country, or you simply want to learn more about the new updates regarding surgical clothing, drapes, medical face masks, and sterilizers for medical use, keep reading because we explain everything in detail.
When and why was the update introduced?
With the aim of improving processes, the European authorized representative brought into effect on October 20, 2025 a set of protocols that ensure the effectiveness of medical devices so they comply with current regulations.
The decision was not arbitrary. It responds to a request submitted by the Commission to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), which sought a review of the existing standards to align them with new technical and scientific advances.
This review has resulted in new standards such as EN 13795-1:2025 and EN 13795-2:2025 for surgical clothing and drapes; EN 14683:2025 for medical face masks; and EN 14180:2025 for low-temperature steam and formaldehyde sterilizers.
These updates not only modernize the methods but also align them with the latest general safety and performance requirements, ensuring greater protection against the transmission of infectious agents.
Because this is such an important matter, the new regulations also impact manufacturers, distributors, and organizations involved in the trade of related products. Significant changes are coming that will positively influence the healthcare sector across the European Union.
Standards for Surgical Clothing and Drapes: EN 13795-1:2025 and EN 13795-2:2025
One of the most important updates relates to surgical clothing and drapes, which play a critical role in infection prevention. The new framework establishes specific requirements and testing methods for drapes and gowns, including both single-use and reusable products.
The scope of the regulation is broad, as it aims to establish sufficient safety standards for patients, clinical staff, equipment, and more. The goal is to improve microbial cleanliness, reduce particle release, and increase resistance to liquid penetration.
Updates to Medical Face Masks: EN 14683:2025
While medical face masks have always been part of the standard protective equipment used by healthcare professionals, their relevance increased significantly after the pandemic. They serve as one of the main barriers against clinical respiratory pathogens, and the new standard brings important updates.
The new framework requires compliance with specific construction, design, performance, and testing requirements for masks used as a barrier between infectious agents, clinical staff, and patients during invasive, non-invasive, and even routine medical procedures.
Among the updated performance requirements, breathability criteria have been redesigned. Reusable face masks are now recognized as an important part of the process, promoting the circular economy. Additionally, the possibility of using transparent masks has been included to facilitate communication with deaf patients or older adults.
Standards for Sterilizers: EN 14180:2025
Sterilizers, along with sterilization processes, are essential to ensure the elimination of infectious agents, microorganisms, and other potential risks in medical environments. This regulation pays special attention to medical devices and sterilization procedures.
To comply with the new standard, it is necessary to consider performance requirements and tests for equipment using low-temperature steam mixtures and sterilizing agents. The regulation addresses validation, cycle control, and monitoring, ensuring sterilization effectiveness without compromising equipment functionality.
Some believe that the updates are limited compared to the 2014 version, but this is not the case. The standard incorporates reviews and advances in chemical and operational safety that have emerged in recent years. Without a doubt, this update places greater emphasis on specific testing that helps minimize risks.
Knowing the decisions adopted by the European Union in the new 2025/2078 standards is essential, whether you are a healthcare professional, a manufacturer, or even a patient.
When it comes to health, we are all involved. These new regulations aim to establish higher safety standards, and with the recent updates, this is possible. Not only do they minimize infectious risks, but they also contribute to a more integrated healthcare system in which both medical personnel and patients face fewer hazards.