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: 312

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

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 (Ratificada)

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 60601-2-16:2025 (Ratificada)

Status: VIGENTE /  2025-04-01

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in April of 2025.)

UNE-EN IEC 80601-2-71:2025 (Ratificada)

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 60601-2-39:2025 (Ratificada)

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 60601-2-40:2025 (Ratificada)

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 (Ratificada)

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 (Ratificada)

Status: VIGENTE /  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 60601-2-10:2015/A2:2024 (Ratificada)

Status: VIGENTE /  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 IEC 60601-2-2:2018/A1:2024 (Ratificada)

Status: VIGENTE /  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 (Ratificada)

Status: VIGENTE /  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 IEC 60601-2-33:2024 (Ratificada)

Status: VIGENTE /  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 60601-2-45:2011/A2:2024 (Ratificada)

Status: VIGENTE /  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 (Ratificada)

Status: VIGENTE /  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 80601-2-49:2019/A1:2024 (Ratificada)

Status: VIGENTE /  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 60601-2-54:2024 (Ratificada)

Status: VIGENTE /  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 80601-2-58:2024 (Ratificada)

Status: VIGENTE /  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 60601-2-6:2015/A2:2024 (Ratificada)

Status: VIGENTE /  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 IEC 60601-2-75:2019/A1:2024 (Ratificada)

Status: VIGENTE /  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 80601-2-78:2020/A1:2024 (Ratificada)

Status: VIGENTE /  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.)

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