IEC/AWI 60601-1-10Under development

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

Appareils électromédicaux — Partie 1-10: Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale: Exigences pour le développement des régulateurs physiologiques en boucle fermée

Abstract / 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

Replaces

IEC 60601-1-10:2007PublishedMedical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllersInternational Standard · Published 29 Nov 2007 · ISO/TC 121/SC 3 IEC 60601-1-10:2007/Amd 1:2013PublishedMedical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers — Amendment 1International Standard · Published 29 Nov 2013 · ISO/TC 121/SC 3 IEC 60601-1-10:2007/Amd 2:2020PublishedMedical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers — Amendment 2International Standard · Published 21 Sep 2020 · ISO/TC 121/SC 3