NEWS
Two key standards supporting safe steam sterilization and pressure equipment have been cited in the Official Journal of the European Union (OJEU). EN 13060:2025 on small steam sterilizers and EN 14222:2021+A1:2025 on stainless steel steam boilers now provide harmonized tools to demonstrate conformity with the Medical Device Regulation for a wide range of sterilization equipment.
A new joint CEN-CENELEC Workshop is being planned as part of the activities of the EU project “CYMEDSEC” - “Enhanced Cybersecurity for Networked Medical Devices through Optimisation of Guidelines, Standards, Risk Management and Security by Design”. This project is focussed on cybersecurity in Europe’s healthcare systems and revolutionizing patient care.
The recently published EN IEC 60601-2-57:2026 specifies essential safety and performance requirements for non-laser light source equipment used in medical and aesthetic applications. This European standard, which fully adopts the international text IEC 60601-2-57:2023, is set to formally enter into force at the beginning of 2026.
A new CEN Workshop is being established to build upon the innovative outcomes of the R&I project BiSCUIT, funded under the Horizon Europe programme. The project focuses on the validation of a dynamic and biomimetic blood-brain barrier model, integrating sensing features to allow a real-time evaluation of barrier formation and integrity maintenance.
The EN ISO 15883 series, jointly developed under the Vienna agreement by ISO/TC 198 and CEN/TC 102, describes the design and functionality of washer-disinfectors (WD), used to disinfect medical tools. Part 1 of the series specifies general design requirements, process specifications and validation methods for all kinds of washer-disinfectors. The subsequent parts focus on the design of particular devices, processing special load including particular specifications of the processing process, such as requirements for the thermal processing of surgical instruments or the chemo-thermal processing of flexible endoscopes.