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IEC/AWI 60601-1-10

Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers

General information

20.00     12 jan 2026

IEC

ISO/TC 121/SC 3

International Standard

Scope

Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable.

Life cycle

PREVIOUSLY

PUBLISHED
IEC 60601-1-10:2007

PUBLISHED
IEC 60601-1-10:2007/Amd 1:2013

PUBLISHED
IEC 60601-1-10:2007/Amd 2:2020

NOW

IN_DEVELOPMENT
IEC/AWI 60601-1-10
20.00 New project registered in TC/SC work programme
12 jan 2026