prCEN ISO/TS 24971-2

Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence prCEN ISO/TS 24971-2

Scope

This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle.

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

This document addresses the same types of risk that are addressed in 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 document also provides examples and suggests strategies for eliminating or mitigating the associated risk.