British Standards Institution

Source:: IEC
Committee:: CH/62/2 - Medical imaging equipment, software, and systems
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. General | Medical equipment. Diagnostic

Scope

This document specifies algorithm performance test methods of computer assisted analysis software for pulmonary images based on artificial intelligence technology. This document is applicable to medical device that uses artificial intelligence to achieve post-processing functions such as computer assisted diagnosis, detection, screening, triage, priority evaluation and prognosis assessment.

Purpose

AI-supported analysis of radiology images is a brooming subbranch of medical device industry and numerous products have been approved on markets worldwide. Currently there is no specific international standard

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

Standard timeline

1. Proposal

Proposal start date:

02/06/2023

Proposal end date:

18/07/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

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Standards Development

PNW 62B-1321 ED1: Artificial Intelligence enabled Medical Devices ? computer assisted analysis software for pulmonary images - algorithm performance test methods

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