Abstract

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.

Begin

2025-10-07

WI

78779

Planned document number

DIN EN IEC 63524

Project number

08000455

Responsible national committee

NA 080-00-06 AA - Image acquisition systems  

Responsible european committee

CLC/TC 62 - Electrical equipment in medical practice  

draft standard

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
2025-12
Order from DIN Media