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IEC 60601-1-10:2007

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

Edition date: 2007-11-21
In Force
Available languages: Spanish, English, French
Summary: 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. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.

Spécifie les exigences pour le développement (analyse, conception, vérification et validation) d'un régulateur physiologique en boucle fermée (RPBF) en tant que partie d'un système physiologique de commande en boucle fermée (SPCBF) dans les appareils em et les systèmes em pour la commande d'une variable physiologique. La présente norme collatérale s'applique aux différents types de RPBF, par exemple linéaire et non-linéaire, adaptatifs, fuzzy, réseaux de neurones. La présente norme collatérale s'applique à un régulateur en boucle fermée qui règle la variable de sortie du régulateur afin d'ajuster (c'est-à-dire, changer ou maintenir) la variable physiologique mesurée en effectuant une comparaison avec la variable de référence.
ICS: 11.040.01-Medical equipment in general
CTN: TC 62/SC 62A - 1359

Modificaciones Normas

Es modificada por IEC 60601-1-10:2007/AMD1:2013

Es modificada por IEC 60601-1-10:2007/AMD2:2020

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