Ultimas normas … (SoTA)
CEN CENELEC
| Reference | Title | DOW |
| EN 17430:2024 | Chemical disinfectants and antiseptics – Hygienic handrub virucidal – Test method and requirements (phase 2/step 2) | 2024-09-30 |
| EN 17854:2024 | Antimicrobial wound dressings – Requirements and test method | 2024-09-30 |
| EN 1865-2:2024 | Patient handling equipment used in ambulances – Part 2: Power assisted stretcher | 2024-12-31 |
| EN 1865-6:2024 | Patient handling equipment used in ambulances – Part 6: Powered chairs | 2025-04-30 |
| EN 455-1:2020+A2:2024 | Medical gloves for single use – Part 1: Requirements and testing for freedom of holes | 2025-03-31 |
| EN 455-2:2024 | Medical gloves for single use – Part 2: Requirements and testing for physical properties | 2024-11-30 |
| EN 556-1:2024 | Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices | 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 | 2025-05-31 |
| EN 60601-1:2006/A13:2024 | Medical electrical equipment – Part 1: General requirements for safety | 2027-02-28 |
| EN 60601-2-10:2015/A2:2024 | Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | 2027-07-31 |
| EN 60601-2-3:2015/A2:2024 | Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment | 2027-07-31 |
| EN 60601-2-45:2011/A2:2024 | Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | 2027-09-20 |
| EN 60601-2-6:2015/A2:2024 | Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment | 2027-07-31 |
| EN IEC 60601-2-2:2018/A1:2024 | Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | 2027-07-31 |
| EN IEC 60601-2-33:2024 | Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2027-09-20 |
| EN IEC 60601-2-35:2021/A1:2024 | Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use | 2027-01-25 |
| EN IEC 60601-2-46:2024 | Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables | 2027-07-31 |
| EN IEC 60601-2-54:2024 | Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2027-07-31 |
| EN IEC 60601-2-75:2019/A1:2024 | Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | 2027-07-31 |
| EN IEC 61223-3-8:2024 | Evaluation and routine testing in medical imaging departments – Part 3-8: Acceptance and constancy tests – Imaging performance of X-ray equipment for radiography and radioscopy | 2027-04-30 |
| EN IEC 61674:2024 | Medical electrical equipment – Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging | 2027-08-13 |
| EN IEC 61676:2023/AC:2024-02 | Medical electrical equipment – Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology | |
| EN IEC 80601-2-26:2020/A1:2024 | Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2027-03-20 |
| EN IEC 80601-2-49:2019/A1:2024 | Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | 2027-10-31 |
| EN IEC 80601-2-58:2024 | Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | 2027-07-31 |
| EN IEC 80601-2-78:2020/A1:2024 | Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation | 2027-07-31 |
| EN ISO 10394:2024 | Dentistry – Designation system for supernumerary teeth (ISO 10394:2023) | 2024-09-30 |
| EN ISO 11139:2018/A1:2024 | Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards – Amendment 1: Amended and additional terms and definitions (ISO 11139:2018/Amd 1:2024) | 2024-07-31 |
| EN ISO 11334-4:2024 | Assistive products for walking, manipulated by one arm – Requirements and test methods – Part4: Walking sticks with three or more legs (ISO 11334-4:2024) | 2025-04-30 |
| EN ISO 11979-7:2024 | Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024) | 2024-07-31 |
| EN ISO 12417-1:2024 | Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products – Part 1: General requirements (ISO 12417-1:2024) | 2024-08-31 |
| EN ISO 13408-1:2024 | Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) | 2024-10-31 |
| EN ISO 14356:2024 | Dentistry – Duplicating material (ISO 14356:2024) | 2025-04-30 |
| EN ISO 15002:2024 | Flow control devices for connection to a medical gas supply system (ISO 15002:2023) | 2024-09-30 |
| EN ISO 15098:2024 | Dentistry – Dental tweezers (ISO 15098:2024) | 2025-01-31 |
| EN ISO 16021:2024 | Absorbent incontinence products for urine and/or faeces – Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024) | 2024-10-31 |
| EN ISO 16571:2024 | Systems for evacuation of plume generated by medical devices (ISO 16571:2024) | 2024-10-31 |
| 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) | 2024-11-30 |
| 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) | 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) | 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) | 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) | 2027-06-30 |
| 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) | 2027-06-30 |
| EN ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) | 2025-04-30 |
| EN ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) | 2025-04-30 |
| EN ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) | 2025-04-30 |
| EN ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024) | 2025-04-30 |
| EN ISO 20342-5:2024 | Assistive products for tissue integrity when lying down – Part 5: Test method for resistance to cleaning and disinfection (ISO 20342-5:2024) | 2025-03-31 |
| EN ISO 20916:2024 | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) | 2027-03-31 |
| EN ISO 21535:2024 | Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023) | 2025-01-31 |
| EN ISO 21536:2024 | Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023) | 2025-01-31 |
| EN ISO 23402-3:2024 | Dentistry – Portable dental equipment for use in non-permanent healthcare environment – Part 3: Portable suction equipment (ISO 23402-3:2024) | 2024-11-30 |
| EN ISO 23500-1:2024 | Preparation and quality management of fluids for haemodialysis and related therapies – Part 1: General requirements (ISO 23500-1:2024) | 2025-03-31 |
| EN ISO 23500-2:2024 | Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024) | 2025-01-31 |
| EN ISO 23500-3:2024 | Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024) | 2024-10-31 |
| EN ISO 23500-4:2024 | Preparation and quality management of fluids for haemodialysis and related therapies – Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024) | 2024-10-31 |
| EN ISO 23500-5:2024 | Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024) | 2024-10-31 |
| EN ISO 25539-3:2024 | Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters (ISO 25539-3:2024) | 2025-04-30 |
| EN ISO 5362:2024 | Anaesthetic and respiratory equipment – Anaesthetic reservoir bags (ISO 5362:2024) | 2025-01-31 |
| EN ISO 5365:2024 | Dentistry – Designation system for tooth developmental stages (ISO 5365:2024) | 2024-09-30 |
| EN ISO 5832-1:2024 | Implants for surgery – Metallic materials – Part 1: Wrought stainless steel (ISO 5832-1:2024) | 2024-10-31 |
| EN ISO 5832-7:2024 | Implants for surgery – Metallic materials – Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024) | 2024-10-31 |
| EN ISO 6872:2024 | Dentistry – Ceramic materials (ISO 6872:2024) | 2025-02-28 |
| EN ISO 7199:2024 | Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) (ISO 7199:2024) | 2025-03-31 |
| EN ISO 7921:2024 | Ophthalmic optics and instruments – Near reading charts (ISO 7921:2024) | 2024-08-31 |
| EN ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2024-09) | 2025-02-28 |
| EN ISO 80601-2-79:2024 | Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024) | 2025-03-31 |
| EN ISO 80601-2-80:2024 | Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024) | 2025-03-31 |
| EN ISO 81060-2:2019/A2:2024 | Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type – Amendment 2 (ISO 81060-2:2018/Amd 2:2024) | 2024-10-31 |
| EN ISO 8362-2:2024 | Injection containers and accessories – Part 2: Closures for injection vials (ISO 8362-2:2024) | 2024-10-31 |
| EN ISO 8536-13:2024 | Infusion equipment for medical use – Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024) | 2025-03-31 |
| EN ISO 8637-2:2024 | Extracorporeal systems for blood purification – Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024) | 2024-10-31 |
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 + 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
