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.
EN 13060:2025 ‘Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing’ sets requirements for performance, safety, and testing for automatically controlled small steam sterilizers. The sterilizers in scope have a chamber volume of less than 60 litres as they cannot accommodate the standard 300 × 300 × 600 mm module. These sterilizers are used to process medical devices and other items likely to come into contact with blood or bodily fluids. They are widely used in general medical practice, dentistry, podiatry, veterinary practice, and facilities for personal hygiene and beauty care. The standard covers design and construction, control and monitoring systems, as well as performance tests. These include air removal, steam penetration, microbiological efficacy, and drying, as well as the information manufacturers have to supply. It distinguishes between type B, N, and S sterilization cycles and aligns closely with EN ISO 17665 on moist heat sterilization, EN ISO 14971 on risk management, and EN ISO 11139 on terminology.
EN 14222:2021+A1:2025 ‘Stainless steel steam boilers’ specifies requirements for electrically heated stainless steel steam boilers that generate steam for sterilizers and disinfectors. It covers boilers heated by immersion heaters with a maximum allowable pressure not greater than 6 bar, a maximum volume of 1 000 litres, and a product PS × V not greater than 3 000 bar·l. The standard sets requirements for materials, design, manufacture, inspection, and testing. It also covers equipment such as safeguards against excessive pressure, water level and steam pressure indication, drain and blowdown devices, limiting devices, and safety circuits. The standard is closely linked to the EN 13445 series on unfired pressure vessels and EN 12953 on shell boilers, and provides specific provisions for small steam boilers integrated into medical sterilization systems.
Through their citation in the OJEU, EN 13060:2025 and EN 14222:2021+A1:2025 offer manufacturers, sterilizer users, and regulators clear, harmonized technical tools to demonstrate conformity with the requirements of the Medical Device Regulation (MDR) and the Pressure Equipment Directive (PED). Together, they support safe, reliable steam generation and sterilization performance, enhance transparency across the European market, and contribute to consistent implementation of EU legislation in the field of medical sterilization and associated pressure equipment.
We wish to express our sincere appreciation to the experts of CEN/TC 102 and its CEN/TC 102/WG 5 ‘Steam Sterilizers’, as well as to DIN, which holds the secretariat, for their dedication and continued work. In case of questions, please contact Zia Weber.
