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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: 312

UNE-EN 60601-1-6:2010/A2:2021 (Ratificada)

Status: VIGENTE2021-09-01

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE-EN IEC 60601-2-1:2021 (Ratificada)

Status: VIGENTE2021-09-01

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE-EN IEC 60601-2-19:2021 (Ratificada)

Status: VIGENTE2021-09-01

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 September of 2021.)

UNE-EN IEC 60601-2-21:2021 (Ratificada)

Status: VIGENTE2021-09-01

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 September of 2021.)

UNE-EN IEC 60601-2-35:2021 (Ratificada)

Status: VIGENTE2021-09-01

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE-EN IEC 60601-2-50:2021 (Ratificada)

Status: VIGENTE2021-09-01

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 September of 2021.)

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

Status: VIGENTE2021-08-01

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

Status: VIGENTE2021-07-01

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 60601-1-2:2015/A1:2021 (Ratificada)

Status: VIGENTE2021-05-01

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)

UNE-EN IEC 60601-2-83:2020/A11:2021 (Ratificada)

Status: VIGENTE2021-05-01

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 May of 2021.)

UNE-EN 60601-1-3:2008/A2:2021 (Ratificada)

Status: VIGENTE2021-04-01

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Endorsed by Asociación Española de Normalización in April of 2021.)

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

Status: VIGENTE2021-04-01

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 60336:2021 (Ratificada)

Status: VIGENTE2021-03-01

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in March of 2021.)

UNE-EN IEC 63073-1:2020 (Ratificada)

Status: VIGENTE2021-01-01

Dedicated Radionuclide Imaging Devices - Characteristics and Test Conditions - Part 1: Cardiac SPECT (Endorsed by Asociación Española de Normalización in January of 2021.)

UNE-EN IEC 60601-2-20:2020 (Ratificada)

Status: VIGENTE2020-11-01

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 November of 2020.)

UNE-EN 60601-1-12:2015/A1:2020 (Ratificada)

Status: VIGENTE2020-10-01

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (Endorsed by Asociación Española de Normalización in October of 2020.)

UNE-EN 60601-1-9:2008/A2:2020 (Ratificada)

Status: VIGENTE2020-10-01

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (Endorsed by Asociación Española de Normalización in October of 2020.)

UNE-EN 62366-1:2015/A1:2020 (Ratificada)

Status: VIGENTE2020-09-01

Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)

UNE-EN IEC 61223-3-6:2020 (Ratificada)

Status: VIGENTE2020-05-01

Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation (Endorsed by Asociación Española de Normalización in May of 2020.)

UNE-EN IEC 60580:2020 (Ratificada)

Status: VIGENTE2020-05-01

Medical electrical equipment - Dose area product meters (Endorsed by Asociación Española de Normalización in May of 2020.)