PD CEN ISO/TS 24971-2:2026

This standard PD CEN ISO/TS 24971-2:2026 Medical devices. Guidance on the application of ISO 14971 is classified in these ICS categories:

• 35.240.80 IT applications in health care technology
• 35.240.01 Application of information technology in general
• 11.040.01 Medical equipment in general

This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI.