CEN/CLC/TC 3
| Project No. | LVS CEN ISO/TS 24971-2:2026 |
|---|---|
| Title | 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. |
| Registration number (WIID) | 80075 |
| Scope | 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. |
| Status | Not set |
| ICS group | 35.240.80 35.240.01 11.040.01 |