Ultimas normas … (SoTA)
CEN CENELEC
MDR
| EN ISO 23908:2025 | Sharps injury protection – Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration – Requirements and test methods (ISO 23908:2024) | Published | 2026-02-28 |
| EN ISO 22675:2025 | Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2024) | Published | 2025-11-30 |
| EN ISO 21850-2:2025 | Dentistry – Materials for dental instruments – Part 2: Polymers (ISO 21850-2:2025) | Published | 2025-12-31 |
| 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 |
| 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 |
| 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 |
| EN ISO 15883-1:2025 | Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024) | Published | 2025-09-30 |
| EN ISO 14889:2025 | Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2025) | Published | 2025-12-31 |
| EN ISO 14607:2025 | Non-active surgical implants – Mammary implants – Specific requirements (ISO 14607:2024) | Published | 2026-02-28 |
| EN ISO 12870:2025 | Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2024) | Published | 2026-02-28 |
| EN ISO 10993-5:2009/A11:2025 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | Published | 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 |
| EN ISO 10993-23:2021/A1:2025 | Biological evaluation of medical devices – Part 23: Tests for irritation – Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025) | Published | 2026-02-28 |
| EN ISO 10993-12:2021/A1:2025 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials – Amendment 1 (ISO 10993 12:2021/Amd 1:2025) | Published | 2026-03-31 |
| 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 | Published | 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 | 2028-04-30 |
| EN 14683:2025 | Medical face masks – Requirements and test methods | Published | 2025-07-31 |
| EN 14222:2021+A1:2025 | Stainless steel steam boilers | Published | 2026-03-31 |
| EN 14180:2025 | Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing | Published | 2025-10-31 |
| EN 13795-2:2025 | Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits | Published | 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 |
| EN 13060:2025 | Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing | Published | 2026-02-28 |
| CEN/TR 12401:2025 | Dentistry – Guidance on the classification of dental devices and accessories | Published |
MEDICAL EQUIPMENT
| Reference | Title | Status | DOW |
| EN ISO 9917-1:2025 | Dentistry – Water-based cements – Part 1: Acid-base cements (ISO 9917-1:2025) | Published | 2025-12-31 |
| EN ISO 8871-5:2025 | Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 5: Functional requirements and testing (ISO 8871-5:2025) | Published | 2025-09-30 |
| EN ISO 8536-16:2025 | Infusion equipment for medical use – Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025) | Published | 2026-02-28 |
| EN ISO 80369-6:2025 | Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neural applications (ISO 80369-6:2025) | Published | 2025-12-31 |
| EN ISO 7711-1:2021/A1:2025 | Dentistry – Diamond rotary instruments – Part 1: General requirements – Amendment 1 (ISO 7711-1:2021/Amd 1:2025) | Published | 2025-07-31 |
| EN ISO 7405:2025 | Dentistry – Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025) | Published | 2026-01-31 |
| EN ISO 7396-3:2025 | Medical gas pipeline systems – Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025) | Published | 2026-01-31 |
| EN ISO 7376:2020/A1:2025 | Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation – Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025) | Published | 2025-12-31 |
| EN ISO 6877:2025 | Dentistry – Endodontic obturating materials (ISO 6877:2025) | Published | 2026-02-28 |
| EN ISO 5840-3:2021/A1:2025 | Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques – Amendment 1 (ISO 5840-3:2021/Amd 1:2025) | Published | 2025-09-30 |
| EN ISO 5840-2:2021/A1:2025 | Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes – Amendment 1 (ISO 5840-2:2021/Amd 1:2025) | Published | 2025-09-30 |
| EN ISO 5840-1:2021/A1:2025 | Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements – Amendment 1 (ISO 5840-1:2021/Amd 1:2025) | Published | 2025-09-30 |
| EN ISO 5832-2:2025 | Implants for surgery – Metallic materials – Part 2: Unalloyed titanium (ISO 5832-2:2025) | Published | 2026-03-31 |
| EN ISO 4823:2025 | Dentistry – Elastomeric impression and bite registration materials (ISO 4823:2025, Corrected version 2025-08) | Published | 2025-12-31 |
| EN ISO 23908:2025 | Sharps injury protection – Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration – Requirements and test methods (ISO 23908:2024) | Published | 2026-02-28 |
| EN ISO 23698:2025 | Cosmetics – Measurement of the sunscreen efficacy by diffuse reflectance spectroscopy (ISO 23698:2024) | Published | 2025-07-31 |
| EN ISO 23675:2025 | Cosmetics – Sun protection test methods – In vitro determination of sun protection factor (SPF) (ISO 23675:2024) | Published | 2025-07-31 |
| EN ISO 22675:2025 | Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2024) | Published | 2025-11-30 |
| EN ISO 21850-2:2025 | Dentistry – Materials for dental instruments – Part 2: Polymers (ISO 21850-2:2025) | Published | 2025-12-31 |
| EN ISO 20127:2025 | Dentistry – Physical properties of powered toothbrushes (ISO 20127:2025) | Published | 2025-11-30 |
| EN ISO 19490:2025 | Dentistry – Sinus membrane elevator (ISO 19490:2025) | Published | 2026-02-28 |
| EN ISO 19211:2025 | Anaesthetic and respiratory equipment – Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024) | Published | 2026-02-28 |
| EN ISO 18618:2025 | Dentistry – Interoperability of CAD/CAM systems (ISO 18618:2025) | Published | 2026-02-28 |
| EN ISO 18397:2025 | Dentistry – Powered scaler (ISO 18397:2025) | Published | 2026-01-31 |
| EN ISO 18374:2025 | Dentistry – Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis – Data generation, data annotation and data processing (ISO 18374:2025) | Published | 2025-11-30 |
| EN ISO 17730:2025 | Dentistry – Fluoride varnishes (ISO 17730:2025) | Published | 2026-03-31 |
| EN ISO 16671:2025 | Ophthalmic implants – Irrigating solutions for ophthalmic surgery (ISO 16671:2025) | Published | 2025-12-31 |
| EN ISO 16408:2025 | Dentistry – Oral care products – Oral rinses (ISO 16408:2025) | Published | 2026-01-31 |
| 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 |
| 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 |
| 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 |
| EN ISO 15883-1:2025 | Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024) | Published | 2025-09-30 |
| EN ISO 14889:2025 | Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2025) | Published | 2025-12-31 |
| EN ISO 14607:2025 | Non-active surgical implants – Mammary implants – Specific requirements (ISO 14607:2024) | Published | 2026-02-28 |
| EN ISO 13402:2025 | Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:2025) | Published | 2025-09-30 |
| EN ISO 12870:2025 | Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2024) | Published | 2026-02-28 |
| EN ISO 11980:2025 | Ophthalmic optics – Contact lenses and contact lens care products – Requirements and guidance for clinical investigations (ISO 11980:2025) | Published | 2026-01-31 |
| EN ISO 10993-5:2009/A11:2025 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | Published | 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 |
| EN ISO 10993-23:2021/A1:2025 | Biological evaluation of medical devices – Part 23: Tests for irritation – Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025) | Published | 2026-02-28 |
| EN ISO 10993-12:2021/A1:2025 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials – Amendment 1 (ISO 10993 12:2021/Amd 1:2025) | Published | 2026-03-31 |
| EN IEC 80601-2-71:2025 | Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment | Published | 2028-02-29 |
| EN IEC 63322:2025 | Security of ME equipment containing high-activity sealed radioactive sources | Published | 2028-09-30 |
| 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 | Published | 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 | 2028-04-30 |
| EN IEC 60601-2-40:2025 | Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment | Published | 2028-02-29 |
| EN IEC 60601-2-39:2025 | Medical electrical equipment – Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment | Published | 2028-01-31 |
| EN IEC 60601-2-16:2025 | Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | Published | 2028-02-29 |
| EN 868-7:2025 | Packaging for terminally sterilized medical devices – Part 7: Adhesive coated paper for low temperature sterilization processes – Requirements and test methods | Published | 2025-10-31 |
| EN 868-6:2025 | Packaging for terminally sterilized medical devices – Part 6: Paper for low temperature sterilization processes – Requirements and test methods | Published | 2025-10-31 |
| EN 868-4:2025 | Packaging for terminally sterilized medical devices – Part 4: Paper bags – Requirements and test methods | Published | 2025-10-31 |
| EN 868-3:2025 | Packaging for terminally sterilized medical devices – Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) – Requirements and test methods | Published | 2025-10-31 |
| EN 868-2:2025 | Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods | Published | 2025-10-31 |
| EN 455-5:2025 | Medical gloves for single use – Part 5: Extractable chemical residues | Published | 2026-02-28 |
| EN 17999:2025 | Accessible systems for living independently – Requirements and recommendations | Published | 2025-11-30 |
| EN 17915:2025 | Chemical disinfectants and antiseptics – Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the food, industrial, domestic and institutional area – Test method and requirements (phase 2, step 2). | Published | 2025-12-31 |
| EN 17914:2025 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the food, industrial, domestic and institutional area – Test method and requirements (Phase 2/Step 1) | Published | 2025-12-31 |
| EN 17272:2020+A1:2025 | Chemical disinfectants and antiseptics – Methods of airborne room disinfection by automated process – Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities | Approved | 2026-04-30 |
| EN 16616:2022+A1:2025 | Chemical disinfectants and antiseptics – Chemical-thermal textile disinfection – Test method and requirements (phase 2, step 2) | Approved | 2026-04-30 |
| EN 16128:2025 | Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release | Approved | 2026-04-30 |
| EN 14683:2025 | Medical face masks – Requirements and test methods | Published | 2025-07-31 |
| EN 14476:2025 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1) | Published | 2026-04-30 |
| EN 14349:2025 | Chemical disinfectants and antiseptics – Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action – Test method and requirements (phase 2, step 2) | Published | 2025-11-30 |
| EN 14222:2021+A1:2025 | Stainless steel steam boilers | Published | 2026-03-31 |
| EN 14204:2025 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area – (phase 2, step 1) | Published | 2026-02-28 |
| EN 14180:2025 | Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing | Published | 2025-10-31 |
| EN 13795-2:2025 | Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits | Published | 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 |
| EN 13060:2025 | Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing | Published | 2026-02-28 |
| CEN/TR 12401:2025 | Dentistry – Guidance on the classification of dental devices and accessories | Published |
IVDR
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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
