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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 IEC 60601-2-43:2023 (Ratificada)

Status: VIGENTE2026-01-05

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 60601-2-44:2010

Status: VIGENTE2026-01-05

Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

UNE-EN 60601-2-44:2010/A1:2012 (Ratificada)

Status: VIGENTE2026-01-05

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 60601-2-44:2010/A2:2016 (Ratificada)

Status: VIGENTE2026-01-05

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 60601-2-45:2011 (Ratificada)

Status: VIGENTE2026-01-05

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 AENOR in July of 2011.)

UNE-EN 60601-2-45:2011/A1:2015 (Ratificada)

Status: VIGENTE2026-01-05

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 AENOR in November of 2015.)

UNE-EN 60601-2-45:2011/A2:2024 (Ratificada)

Status: VIGENTE2026-01-05

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 60601-2-54:2024 (Ratificada)

Status: VIGENTE2026-01-05

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 60601-2-63:2015 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by AENOR in July of 2015.)

UNE-EN 60601-2-63:2015/A2:2021 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2021.)

UNE-EN 60601-2-63:2015/A1:2019 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in November of 2019.)

UNE-EN 60601-2-65:2013 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Endorsed by AENOR in March of 2013.)

UNE-EN 60601-2-65:2013/A2:2021 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in July of 2021.)

UNE-EN 60601-2-65:2013/A1:2020 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN IEC 60522-1:2021 (Ratificada)

Status: VIGENTE2026-01-05

Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration (Endorsed by Asociación Española de Normalización in April of 2021.)

UNE-EN IEC 62570:2025 (Ratificada)

Status: VIGENTE2026-01-01

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (Endorsed by Asociación Española de Normalización in January of 2026.)

UNE-EN IEC 63322:2025 (Ratificada)

Status: VIGENTE2025-10-01

Security of ME equipment containing high-activity sealed radioactive sources (Endorsed by Asociación Española de Normalización in October of 2025.)

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

Status: VIGENTE2025-07-01

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: VIGENTE2025-06-01

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: VIGENTE2025-04-01

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.)