Project
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
Abstract
This document specifies requirements for the development (e.g. analysis, design, verification and validation) of a physiologic closed-loop controller (pclc) as part of a physiologic closed-loop control system (pclcs) to control at least one patient variable in medical electrical equipment and medical electrical systems.
Begin
2026-01-28
Planned document number
DIN EN IEC 60601-1-10
Project number
02233614
Responsible national committee
DKE/UK 804.1 - Überarbeitung und Anpassung der allgemeinen Bestimmungen
