prSRPS CEN ISO/TS 24971-2:2026

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026)

Опште информације

Trenutna faza: 10.99 Effective date: 2. 5. 2024.

Inicijator: ISS

Pripada: Z076

Vrsta: Tehnička specifikacija

ICS: 11.040.01

Jezik: engleski

Apstrakt

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.

Životni ciklus

TRENUTNO

PROJEKAT
prSRPS CEN ISO/TS 24971-2:2026
10.99 Novi projekat se prihvata
2. 5. 2024.

prSRPS CEN ISO/TS 24971-2:2026

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026)

Опште информације

Apstrakt

Životni ciklus

TRENUTNO

Povezani projekti

Identičan sa CEN ISO/TS 24971-2:2026 IDENTICAL

Identičan sa ISO/TS 24971-2:2026 IDENTICAL