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 IEC/AWI 60601-1-10

General information

20.00   New project registered in TC/SC work programme   Jan 12, 2026

IEC

ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care

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

NOW

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




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