IEC/NP TS 62366-3

Medical devices — Part 3: Guidance on the application of usability engineering to medical devices using artificial intelligence and machine learning technology

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.