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
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
| Standard number: | IEC 60601-1-10:2007 |
| Released: | 2007-11-21 |
| Language: | English/French - Bilingual |
IEC 60601-1-10:2007
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.