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DIN EN IEC 63524:2025-12

Artificial Intelligence enabled Medical Devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods (IEC 62B/1391/CDV:2025); German and English version prEN IEC 63524:2025 / Note: Date of issue 2025-11-21

Fecha edición: 2025-12-01
En Vigor
Idiomas disponibles: Alemán, Inglés
Resumen: This document describes algorithm performance test methods of computer assisted analysis software for pulmonary radiological images based on artificial intelligence technology. This document is applicable to medical device that uses artificial intelligence to support the post-processing of pulmonary radiological images. The data modality include but is not limited to X-ray, CT (computed tomography)and MRI (magnetic resonance imaging) This document is not applicable to medical device that uses artificial intelligence to support pre-processing or procedure optimization of clinical workflow.

Keywords: Algorithms|Analysis|Artificial intelligence|Computed tomography|Computer software|Computer systems|Computer technology|Computers|Definitions|Diagnosis|Diagnosis (medical)|Imaging|Information technology|Lungs|Machine learning|Magnetic resonances|Medical|Medical equipment|Medical sciences|Medical technology|Methods|Performance|Radiological|Radiology|Rating tests|Software|Testing|Tomography|X-ray
ICS: 35.240.80 - Aplicaciones de las tecnologías de la información en la sanidad
CTN:

Equivalencia Internacional

Idéntica prEN IEC 63524:2025

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