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UNE-EN IEC 80601-2-71:2025 UNE
Status: Vigente/ 2025-04-01
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Endorsed by Asociación Española de Normalización in April of 2025.)
UNE-EN IEC 60601-2-40:2025 UNE
Status: Vigente/ 2025-03-01
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in March of 2025.)
UNE-EN IEC 60601-2-34:2024 UNE
Status: Vigente/ 2025-02-01
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (Endorsed by Asociación Española de Normalización in February of 2025.)
UNE-EN IEC 60601-2-37:2024 UNE
Status: Current/ 2025-01-01
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Endorsed by Asociación Española de Normalización in January of 2025.)
UNE-EN ISO 81060-2:2020/A2:2024 UNE
Status: Vigente/ 2024-11-06
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
UNE-EN IEC 60601-2-33:2024 UNE
Status: Current/ 2024-11-01
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN IEC 60601-2-75:2019/A1:2024 UNE
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN 60601-2-10:2015/A2:2024 UNE
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
UNE-EN IEC 80601-2-49:2019/A1:2024 UNE
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN 60601-2-37:2009/A1:2015 UNE
Status: Current/2024-05-22
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Endorsed by AENOR in September of 2015.)
UNE-EN IEC 80601-2-26:2020/A1:2024 UNE
Status: Vigente/ 2024-05-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2024.)
UNE-EN IEC 61676:2023/AC:2024-02 UNE
Status: Vigente/ 2024-03-01
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology (Endorsed by Asociación Española de Normalización in March of 2024.)
UNE-EN IEC 60601-2-76:2019/A1:2023 UNE
Status: Vigente/ 2023-11-01
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in November of 2023.)
UNE-EN IEC 61010-2-101:2023 UNE
Status: Vigente/ 2023-09-27
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN IEC 61010-2-101:2023/A11:2023 UNE
UNE-EN ISO 81060-3:2023 UNE
Status: Vigente/ 2023-09-20
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
UNE-EN 12470-2:2001+A1:2009 UNE
Status: Vigente/ 2023-06-05
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
UNE-EN IEC 61676:2023 UNE
Status: Vigente/ 2023-06-01
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (Endorsed by Asociación Española de Normalización in June of 2023.)
UNE-EN IEC 80601-2-59:2019/A1:2023 UNE
Status: Vigente/ 2023-04-01
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)
UNE-EN ISO 18778:2022 UNE
Status: Vigente/ 2023-01-01
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)
UNE-EN 60601-2-57:2012 UNE
Status: Vigente/ 2022-10-26
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 and cosmetic/aesthetic use
UNE-EN IEC 62563-2:2021 UNE
Status: Vigente/ 2022-02-01
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-EN IEC 60601-2-41:2021 UNE
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-EN IEC 80601-2-26:2020/AC:2021-10 UNE
Status: Vigente/ 2021-12-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
UNE-EN ISO 80601-2-67:2021 UNE
Status: Vigente/ 2021-11-10
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
UNE-EN 62563-1:2010/A2:2021 UNE
Status: Vigente/ 2021-10-01
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (Endorsed by Asociación Española de Normalización in October of 2021.)
UNE-EN IEC 61010-2-130:2021 UNE
Status: Vigente/ 2021-07-01
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-130: Particular requirements for equipment intended to be used in educational establishments by children
UNE-EN IEC 61010-2-091:2021 UNE
Status: Vigente/ 2021-06-01
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems (Endorsed by Asociación Española de Normalización in June of 2021.)
UNE-EN IEC 61010-2-091:2021/A11:2021 UNE
UNE-EN ISO 81060-2:2020/A1:2021 UNE
Status: Vigente/ 2021-04-28
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
UNE-EN IEC 61010-2-202:2021 UNE
Status: Vigente/ 2021-02-01
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-202: Particular requirements for electrically operated valve actuators (Endorsed by Asociación Española de Normalización in February of 2021.)
UNE-EN ISO 81060-2:2020 UNE
Status: Vigente/ 2020-10-28
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
UNE-EN ISO 80601-2-56:2018/A1:2020 UNE
Status: Vigente/ 2020-09-09
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)
UNE-EN IEC 60601-2-66:2020 UNE
Status: Vigente/ 2020-05-01
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 80601-2-26:2020 UNE
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 63077:2019 UNE
Status: Vigente/ 2020-02-01
Good refurbishment practices for medical imaging equipment (Endorsed by Asociación Española de Normalización in February of 2020.)
UNE-EN IEC 80601-2-49:2019 UNE
Status: Vigente/ 2019-11-01
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (Endorsed by Asociación Española de Normalización in November of 2019.)
UNE-EN IEC 60601-2-28:2019 UNE
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Endorsed by Asociación Española de Normalización in November of 2019.)
UNE-EN IEC 80601-2-59:2019 UNE
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in November of 2019.)
UNE-EN IEC 60601-2-75:2019 UNE
Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2019.)
UNE-EN IEC 60601-2-76:2019 UNE
Status: Vigente/ 2019-07-01
Medical Electrical Equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in July of 2019.)
UNE-EN ISO 80601-2-61:2019 UNE
Status: Vigente/ 2019-04-30
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02)
UNE-EN 60601-2-40:2019 UNE
Status: Vigente/ 2019-02-01
Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in February of 2019.)
UNE-EN ISO 80601-2-56:2018 UNE
Status: Vigente/ 2018-09-19
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
UNE-EN IEC 80601-2-71:2018 UNE
Status: Vigente/ 2018-08-01
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment (Endorsed by Asociación Española de Normalización in August of 2018.)
UNE-EN IEC 61010-2-201:2018 UNE
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-201: Particular requirements for control equipment (Endorsed by Asociación Española de Normalización in August of 2018.)
UNE-EN 61010-2-101:2018 UNE
Status: Vigente/ 2018-04-25
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN ISO 11073-10441:2017 UNE
Status: Vigente/ 2017-04-01
Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015) (Endorsed by Asociación Española de Normalización in April of 2017.)
UNE-EN ISO 11073-00103:2017 UNE
Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) (Endorsed by Asociación Española de Normalización in April of 2017.)
UNE-EN 60601-2-10:2015/A1:2016 UNE
Status: Vigente/ 2017-01-01
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Endorsed by Asociación Española de Normalización in January of 2017.)