British Standards Institution

Source:: IEC
Committee:: CH/62 - Medical equipment, software, and systems
Categories:: Information technology. General
Number of comments:: 0

Scope

Software testing is well treated in standardization (see ISO/IEC/IEEE 29119-1:2022 [1]). For medical devices, requirements on software testing are well established internationally by IEC 62304:2006/Amd 1:2015 [2]. This document establishes additional aspects to specifically test AI component in AI/ML-MD.

AI component considered in this document include locked AI model and AI model that learn under the control of the manufacturer. The case where the AI model is continuously learning in the field under indirect control by the manufacturer is treated in Annex A.

Tests can be conducted at various lifecycle stages of the AI/ML-MD, depending on the nature of the AI model.

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 (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

01/02/2025

3. Public Comments

Public Comments start date:

21/08/2024

Public Comments end date:

02/10/2024

Learn more about the standards development process

Standards Development

BS EN IEC 63450 Ed.1.0 BS EN 63450 Ed.1.0 Testing of Artificial Intelligence / Machine Learning-enabled Medical Devices

Scope

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error