This joint AAMI and British Standard provides guidance for applying a BS EN ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices²⁾ throughout all phases of the product life cycle.

This document is intended to be used in conjunction with BS EN ISO 14971. It does not modify the BS EN ISO 14971 risk management process; rather it provides information and guidance to inform the application of BS EN ISO 14971 to ML medical technology. A risk management process is further detailed in Annex A.

This British Standard addresses the same types of risk that are addressed in BS EN ISO 14971 but focuses on risks that are elevated with or unique to ML medical devices. Because artificial intelligence (AI) and ML are software-driven, the unique or elevated risks are those around data management, feature extraction, algorithm training, evaluation, bias, health inequity, safety, and cyber and information security. This standard also provides examples and suggests strategies for eliminating or mitigating the associated risk.

Annex B provides additional clarification and examples of hazards, hazardous situations and harms, as well as possible risk control strategies in a series of tables that correspond with BS EN ISO 14971:2019+A11, Table C.1, Table C.2, and Table C.3.