Active
Standard
Most Recent
ISO/TS 24971-2:2026
Medical devices — Guidance on the application of ISO 14971
Part 2: Machine learning in artificial intelligence
Part 2: Machine learning in artificial intelligence
Preview
Summary
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.
Notes
60.60 : Norme internationale publiée
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 06/17/2026 |
| Edition | 1 |
| Page Count | 32 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
No products.
Previous versions
No products.