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 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 60601-2-43:2023 (Ratificada)

Status: VIGENTE /  2023-03-01

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 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 60731:2012/A1:2022 (Ratificada)

Status: VIGENTE /  2022-09-01

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (Endorsed by Asociación Española de Normalización in September of 2022.)

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.)

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 61223-3-7:2022 (Ratificada)

Status: VIGENTE /  2022-03-01

Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography (Endorsed by Asociación Española de Normalización in March 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 62563-1:2010/A2:2021 (Ratificada)

Status: VIGENTE /  2021-10-01

Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods (Endorsed by Asociación Española de Normalización in October 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.)

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