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IEC/IEEE 63685 ED1

Post-market surveillance of machine learning-enabled medical devices

General information

20.99     Sep 19, 2025

CD    Apr 3, 2026

IEC

TC 62

International Standard

11.020     11.040  

Life cycle

NOW

IN_DEVELOPMENT
IEC/IEEE 63685 ED1
20.99 WD approved for registration as CD
Sep 19, 2025