EN
SR EN 60601-1-10:2008
Aparate electromedicale. Partea 1-10: Cerinţe particulare de securitate de bază şi performanţe esenţiale. Standard colateral: Cerinţe pentru dezvoltarea regulatoarelor fiziologice în buclă închisă
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.[<BR>]This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.[<BR>]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.
Status :
In vigoare
Data aprobării : 15.09.2008
Data publicării : 17.09.2008
Număr de pagini : 87
ICS : 11.040.01 Echipament medical în general
Comitet tehnic : 22 - Echipamente electromedicale
- Modificat de SR EN 60601-1-10:2008/A1:2015
- Modificat de SR EN 60601-1-10:2008/A2:2021