British Standards Institution

Source:: IEC
Committee:: CH/62/2 - Medical imaging equipment, software, and systems
Categories:: Medical equipment. Diagnostic
Number of comments:: 0

Scope

This document describes algorithm performance test methods of computer assisted analysis software for pulmonary radiological images based on artificial intelligence technology.

This document describes the method of standalone performance test.

This document is applicable to medical device that uses artificial intelligence to support the post-processing of pulmonary radiological images. The algorithm input 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 preprocessing or procedure optimization of clinical workflow.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

17/02/2025

3. Public Comments

Public Comments start date:

13/11/2024

Public Comments end date:

01/01/2025

Learn more about the standards development process

Standards Development

BS EN IEC 63524 ED1 Artificial Intelligence enabled Medical Devices - Computer assisted analysis software for pulmonary images - Algorithm performance test methods

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