ISO/TC 210
| Project No. | ISO/TS 24971-2:2026 |
|---|---|
| Title | <p class="MsoBodyText"><span lang="EN-GB">This document provides guidance on <em style="mso-bidi-font-style: normal;">risks</em> specific to artificial intelligence (AI) and <em style="mso-bidi-font-style: normal;">machine learning</em> (<em style="mso-bidi-font-style: normal;">ML</em>) and how to apply the <em style="mso-bidi-font-style: normal;">risk management process</em> of ISO 14971 to <em style="mso-bidi-font-style: normal;">ML-enabled medical devices</em> (<em style="mso-bidi-font-style: normal;">MLMD</em>). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971</span>[2]<span lang="EN-GB">.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not apply to <em style="mso-bidi-font-style: normal;">MLMD</em> employing large language models (LLM) or generative AI.</span></p> |
| Registration number (WIID) | 87600 |
| Scope | <p class="MsoBodyText"><span lang="EN-GB">This document provides guidance on <em style="mso-bidi-font-style: normal;">risks</em> specific to artificial intelligence (AI) and <em style="mso-bidi-font-style: normal;">machine learning</em> (<em style="mso-bidi-font-style: normal;">ML</em>) and how to apply the <em style="mso-bidi-font-style: normal;">risk management process</em> of ISO 14971 to <em style="mso-bidi-font-style: normal;">ML-enabled medical devices</em> (<em style="mso-bidi-font-style: normal;">MLMD</em>). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971</span>[2]<span lang="EN-GB">.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not apply to <em style="mso-bidi-font-style: normal;">MLMD</em> employing large language models (LLM) or generative AI.</span></p> |
| Status | Standarts spēkā |
| ICS group | 35.240.80 35.240.01 11.040.01 |