British Standards Institution

Source:: IEC
Committee:: CH/62/2 - Medical imaging equipment, software, and systems
Categories:: Standardization. General rules | Healthcare | Medical equipment | Medical equipment. Diagnostic | ICT | Information technology | IT applications. Health care technology

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 regarding testing of such products. In this proposal, specific methods and metrics are described to support verification of algorithm performance. This proposal also covers general verification requirement in Annex A, which may be covered over time by more general AI-enabled medical device standards (e.g. IEC 63450 or NP based on PT8)

Comment on proposal

Required form fields are indicated by an asterisk (*) character.

How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

Discard

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

Standard timeline

1. Proposal

Proposal start date:

13/07/2023

Proposal end date:

01/08/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

62B/1321/NP Artificial Intelligence enabled Medical Devices — computer assisted analysis software for pulmonary images - algorithm performance test methods

Scope

Purpose

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error