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
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.