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BSI PD CEN ISO/TS 24971-2:2026

Medical devices. Guidance on the application of ISO 14971 -- Machine learning in artificial intelligence
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BSI PD CEN ISO/TS 24971-2:2026

Medical devices. Guidance on the application of ISO 14971 -- Machine learning in artificial intelligence

PUBLISH DATE 2026
PAGES 42
BSI PD CEN ISO/TS 24971-2:2026
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.
SDO BSI: British Standards Institution
Document Number CISO/TS 24971-2
Publication Date June 24, 2026
Language en - English
Page Count 42
Revision Level
Supercedes
Committee CH/210/4
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