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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 61675-1:2022 (Ratificada)

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 (Ratificada)

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.)

UNE-EN IEC 62563-2:2021 (Ratificada)

Status: VIGENTE / 2022-02-01

Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-EN IEC 60601-2-41:2021 (Ratificada)

Status: VIGENTE / 2022-02-01

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-EN IEC 80001-1:2021 (Ratificada)

Status: VIGENTE / 2021-12-01

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)

UNE-EN IEC 80601-2-26:2020/AC:2021-10 (Ratificada)

Status: VIGENTE / 2021-12-01

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)

UNE-EN IEC 80601-2-77:2021 (Ratificada)

Status: VIGENTE / 2021-11-01

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 November of 2021.)

UNE-EN 60601-1-10:2008/A2:2021 (Ratificada)

Status: VIGENTE / 2021-09-01

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Endorsed by Asociación Española de Normalización in September of 2021.)

UNE-EN 60601-1-11:2015/A1:2021 (Ratificada)

Status: VIGENTE / 2021-09-01

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endorsed by Asociación Española de Normalización in September of 2021.)

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

Status: VIGENTE / 2021-09-01

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 60601-2-19:2021 (Ratificada)

Status: VIGENTE / 2021-09-01

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: VIGENTE / 2021-09-01

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: VIGENTE / 2021-09-01

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: VIGENTE / 2021-09-01

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

Status: VIGENTE / 2021-05-01

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: VIGENTE / 2021-05-01

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 IEC 60336:2021 (Ratificada)

Status: VIGENTE / 2021-03-01

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: VIGENTE / 2021-01-01

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: VIGENTE / 2020-11-01

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: VIGENTE / 2020-10-01

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.)

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