ISO/TS 24971-2:2026
ISO/TS 24971-2:2026 Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
CDN $296.00
This publication was last reviewed and confirmed in 2026.
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Description
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.
Edition
1
Published Date
2026-06-19
Status
PUBLISHED
Pages
32
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 8384:2019 Ships and marine technology – Dredgers – Vocabulary
CDN $82.00 Add to cart -
ISO 5078:2025 Management of terminology resources – Terminology extraction
CDN $251.00 Add to cart -
ISO 80004:2020 Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects
CDN $82.00 Add to cart -
ISO 2574:1994 Aircraft – Electrical cables – Identification marking
CDN $124.00 Add to cart
