Publication of references of Harmonised Standards for the MDR for medical gloves for single use, sterilization of medical devices and patient handling equipment

Published in the Official Journal: Commission Implementing Decision (EU) 2025/681 of 8 April 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

Update as of April 2025

The European Commission has published in the Official Journal of the EU the reference of Harmonised Standards supporting the Medical Devices Regulation  for products such as:

• EN 1865-2, which specifies the minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment;
• EN 1865-6, which specifies the minimum requirements for the design and performance of power assisted chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment;
• EN 455-1, which specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes;
• EN 455-2, which specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross-contamination for both patient and user;
• EN 556-1, which specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE"; and
• EN 556-2, which specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

The standards have been published by the European Committee for Standardization (CEN), and elaborated by the technical committees CEN/TC 239 Rescue systems, CEN/TC 205 Non-active medical devices and CEN/TC 204 Sterilization of medical devices.

You may find, obtain and download the updated and complete list of harmonised standards under the Medical Devices Regulation: https://genorma.com/en/directive/show/2017/745