IEC 60601-1-10:2007+AMD1:2013 CSV (Consolidated version)

Title

Language: EN Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers

Language: FR Appareils électromédicaux - Partie 1-10: Exigences générales pour lasécurité de base et les performances essentielles - Norme collatérale: Exigences pour le développement des régulateursphysiologiques en boucle fermée

Abstract

Language: EN IEC 60601-1-10:2007+A1:2013 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. This consolidated version consists of the first edition (2007) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.

Language(s)
Language: EN Language: FR
Edition
1.1
Date of issue
27.11.2013
TC 62/SC 62A
ICS Codes
11.040.01
Publication number
60601
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Mandatory Standard according current regulation Mandatory Standard according current regulation

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