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Number of results 327

UNE-EN IEC 60601-2-83:2020/A1:2025  UNE

Status: Vigente/ 2025-07-01

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in July of 2025.)

UNE-EN IEC 60601-2-68:2025  UNE

Status: Vigente/ 2025-06-01

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 (Endorsed by Asociación Española de Normalización in June of 2025.)

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 60601-2-39:2025  UNE

Status: Vigente/ 2025-03-01

Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis 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 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

Status: Current/ 2024-11-01

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 IEC 80601-2-58:2024  UNE

Status: Current/ 2024-11-01

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 (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN IEC 80601-2-78:2020/A1:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN IEC 60601-2-2:2018/A1:2024  UNE

Status: Current/ 2024-11-01

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 (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN 60601-2-3:2015/A2:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN 60601-2-6:2015/A2:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN 60601-2-10:2015/A2:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

UNE-EN 60601-2-45:2011/A2:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN IEC 60601-2-46:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN IEC 60601-2-54:2024  UNE

Status: Current/ 2024-11-01

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN IEC 80601-2-49:2019/A1:2024  UNE

Status: Current/ 2024-11-01

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 IEC 61674:2024  UNE

Status: Vigente/ 2024-10-01

Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging (Endorsed by Asociación Española de Normalización in October of 2024.)

UNE-EN 60601-1:2008/A13:2024  UNE

Status: Vigente/ 2024-06-01

Medical electrical equipment - Part 1: General requirements for safety

UNE-EN IEC 61223-3-8:2024  UNE

Status: Vigente/ 2024-06-01

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 (Endorsed by Asociación Española de Normalización in June of 2024.)

UNE-EN 60601-2-44:2010/A1:2012  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Endorsed by AENOR in December of 2012.)

UNE-EN 60601-1:2008/A1:2013  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by AENOR in November of 2013.)

UNE-EN 60601-1-8:2008/A11:2017  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in April of 2017.)

UNE-EN 60601-2-44:2010/A2:2016  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Endorsed by AENOR in July of 2016.)

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 60601-2-54:2010/A2:2019  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Endorsed by Asociación Española de Normalización in July of 2019.)

UNE-EN 60601-1-8:2008/A2:2021  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE-EN 60601-1:2008/A2:2021  UNE

Status: Current/2024-05-22

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)

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 60601-2-35:2021/A1:2024  UNE

Status: Vigente/ 2024-03-01

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 (Endorsed by Asociación Española de Normalización in March of 2024.)

UNE-EN IEC 80601-2-77:2021/A1:2023  UNE

Status: Vigente/ 2024-02-01

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in February of 2024.)

UNE-EN IEC 60601-2-19:2021/A1:2023  UNE

Status: Vigente/ 2024-01-01

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-EN IEC 60601-2-20:2020/A1:2023  UNE

Status: Vigente/ 2024-01-01

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-EN IEC 60601-2-21:2021/A1:2023  UNE

Status: Vigente/ 2024-01-01

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Endorsed by Asociación Española de Normalización in January of 2024.)

UNE-EN IEC 60601-2-50:2021/A1:2023  UNE

Status: Vigente/ 2024-01-01

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Endorsed by Asociación Española de Normalización in January 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 62220-2-1:2023  UNE

Status: Vigente/ 2023-10-01

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 2-1: Determination of dual-energy subtraction efficiency - Detectors used for dual-energy radiographic imaging (Endorsed by Asociación Española de Normalización in October of 2023.)

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 IEC 60601-2-43:2023  UNE

Status: Vigente/ 2023-03-01

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Endorsed by Asociación Española de Normalización in March of 2023.)

UNE-EN IEC 60806:2023  UNE

Status: Vigente/ 2023-02-01

Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis (Endorsed by Asociación Española de Normalización in February of 2023.)

UNE-EN 60731:2012/A1:2022  UNE

Status: Vigente/ 2022-09-01

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (Endorsed by Asociación Española de Normalización in September of 2022.)

UNE-EN IEC 61223-3-5:2019/AC:2022-07  UNE

Status: Vigente/ 2022-08-01

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2022.)

UNE-EN IEC 60336:2021/AC:2022-07  UNE

Status: Vigente/ 2022-08-01

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in August of 2022.)

UNE-EN IEC 62985:2019/AC:2022-07  UNE

Status: Vigente/ 2022-08-01

Methods for calculating size specific dose estimates (SSDE) for computed tomography (Endorsed by Asociación Española de Normalización in August of 2022.)

UNE-EN IEC 61675-1:2022  UNE

Status: Vigente/ 2022-06-01

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (Endorsed by Asociación Española de Normalización in June of 2022.)

UNE-EN IEC 81001-5-1:2022  UNE

Status: Vigente/ 2022-03-01

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)

Number of results 327

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