British Standards Institution

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

Scope

This Part of IEC 62366, which is a Technical Specification, contains background information and provides guidance that addresses the specific areas that experience suggests can be helpful for those implementing the usability engineering process as defined in IEC 62366-1 for medical devices utilizing artificial intelligence and/or machine learning technology. The technical specification is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

Purpose

The rapid integration of Artificial Intelligence (AI) and machine learning technology into medical devices offers exciting possibilities for healthcare. However, in an environment where safety of patients is paramount and healthcare professionals rely on medical devices for accurate diagnosis and treatment, these AI-enabled devices present unique challenges for usability engineering. IEC 62366-1:2015+A1:2020 is the premier international standard for usability engineering for medical devices including AI-enabled medical devices. Though the standard is designed to be technology -agnostic there is an opportunity to explain how to specifically use it to address the usability challenges which are unique to AI-enabled medical devices. The purpose of this project is to extend the IEC 62366 series of standards with a Technical Specification to provide guidance with practical recommendations for identifying, evaluating, and mitigating use -related risks specific to AI-enabled devices. This Technical Specification will help standard users to comply with the normative standard when applying it to medical devices utilizing artificial intelligence and machine learning specifically

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

Standard timeline

1. Proposal

Proposal start date:

10/03/2025

Proposal end date:

23/04/2025

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

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Standards Development

IEC 62A/1648/NP Medical devices – Part 3: Guidance on the application of usability engineering to medical devices using artificial intelligence and machine learning technology

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