IEC 60601-1-10-ed.1.0

Annotation of standard text IEC 60601-1-10-ed.1.0 :

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. Specifie les exigences pour le developpement (analyse, conception, verification et validation) dun regulateur physiologique en boucle fermee (RPBF) en tant que partie dun systeme physiologique de commande en boucle fermee (SPCBF) dans les appareils em et les systemes em pour la commande dune variable physiologique. La presente norme collaterale sapplique aux differents types de RPBF, par exemple lineaire et non-lineaire, adaptatifs, fuzzy, reseaux de neurones. La presente norme collaterale sapplique a un regulateur en boucle fermee qui regle la variable de sortie du regulateur afin dajuster (cest-a-dire, changer ou maintenir) la variable physiologique mesuree en effectuant une comparaison avec la variable de reference.