Ultimas normas … (SoTA)
CEN CENELEC
EN 17854:2024 Antimicrobial wound dressings – Requirements and test method – DOW 2024-09-30
EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher – DOW 2024-12-31
EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs – DOW 2025-04-30
EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes – DOW 2025-03-31
EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties – DOW 224-11-30
EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices – DOW 2025-01-31
EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 2: Requirements for aseptically processed medical devices – DOW 2025-01-31
FprEN ISO 14630 Non-active surgical implants – General requirements (ISO/FDIS 14630:2024)
EN IEC 61010-2-101:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment – DOW 2025-09-26
EN ISO 18113-1:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
EN ISO 18113-2:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
EN ISO 18113-3:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
EN ISO 18113-4:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
EN ISO 18113-5:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
M575 Lista de normas en mandato de la Comision a CEN-CENELEC para armonizar
Esta es la lista de normas consolidada del mandato
LISTA DE NORMAS ARMONIZADAS MDR
LISTA DE NORMAS ARMONIZADAS IVDR