Ultimas normas … (SoTA)
CEN CENELEC
MDR
| Reference | Title | Status | DOP | DOW |
| FprEN IEC 60601-2-57:2023/prAA:2025 | Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use | Under Approval | ||
| EN ISO 22675:2025 | Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2024) | Published | 2025-11-30 | 2025-11-30 |
| EN ISO 15883-7:2025 | Washer-disinfectors – Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025) | Published | 2025-11-30 | 2025-11-30 |
| EN ISO 15883-3:2025 | Washer-disinfectors – Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024) | Published | 2025-09-30 | 2025-09-30 |
| EN ISO 15883-2:2025 | Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024) | Published | 2025-09-30 | 2025-09-30 |
| EN ISO 15883-1:2025 | Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024) | Published | 2025-09-30 | 2025-09-30 |
| EN ISO 14889:2025 | Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2025) | Approved | 2025-12-31 | 2025-12-31 |
| EN ISO 10993-5:2009/A11:2025 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | Published | 2025-09-30 | 2025-09-30 |
| EN ISO 10993-4:2017/A1:2025 | Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood – Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04) | Published | 2025-08-31 | 2025-08-31 |
| EN IEC 60601-2-83:2020/A1:2025 | Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | Approved | 2026-06-30 | 2028-06-30 |
| EN IEC 60601-2-68:2025 | Medical electrical equipment – Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment | Published | 2026-04-30 | 2028-04-30 |
| EN IEC 60601-2-22:2020/prAA:2025 | Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Under Approval | ||
| EN 14683:2025 | Medical face masks – Requirements and test methods | Published | 2025-07-31 | 2025-07-31 |
| EN 14180:2025 | Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing | Published | 2025-10-31 | 2025-10-31 |
| EN 13795-2:2025 | Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits | Published | 2025-07-31 | 2025-07-31 |
| EN 13795-1:2025 | Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns | Published | 2025-07-31 | 2025-07-31 |
| CEN/TR 12401:2025 | Dentistry – Guidance on the classification of dental devices and accessories | Published |
IVDR
| Reference | Title | Status | DOP | DOW |
| EN ISO 20916:2024 | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) | Published | 2024-09-30 | 2027-03-31 |
| 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) | Published | 2024-12-31 | 2027-06-30 |
| 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) | Published | 2024-12-31 | 2027-06-30 |
| 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) | Published | 2024-12-31 | 2027-06-30 |
| 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) | Published | 2024-12-31 | 2027-06-30 |
| 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) | Published | 2024-12-31 | 2027-06-30 |
| EN ISO 17665:2024 | Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) | Published | 2024-11-30 | 2024-11-30 |
| EN ISO 13408-1:2024 | Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) | Published | 2024-10-31 | 2024-10-31 |
| EN 556-2:2024 | Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 2: Requirements for aseptically processed medical devices | Published | 2025-05-31 | 2025-05-31 |
| EN 556-1:2024 | Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices | Published | 2025-01-31 | 2025-01-31 |
M575 + A1 + A2 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
