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Committee

Committee:

CTN 209/SC 62 - Electrical equipment in medical practice

Secretary:
UNE - ASOCIACIÓN ESPAÑOLA DE NORMALIZACIÓN
International Relations:

IEC/TC 62  Electrical equipment in medical practice

CLC/TC 62  Electrical equipment in medical practice

Standards developed by the committee: CTN 209/SC 62: 314

UNE-EN 60601-1-8:2008/A11:2017 (Ratificada)

Status: VIGENTE / 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 60601-1-8:2008/A2:2021 (Ratificada)

Status: VIGENTE / 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 60601-2-37:2009/A1:2015 (Ratificada)

Status: VIGENTE / 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 (Ratificada)

Status: VIGENTE / 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 IEC 80601-2-26:2020/A1:2024 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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 60806:2023 (Ratificada)

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 IEC 61223-3-5:2019/AC:2022-07 (Ratificada)

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 (Ratificada)

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 (Ratificada)

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.)

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