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
医用电气设备第1-10部分:一般要求
基本安全和基本性能-附带标准:
生理闭环系统的发展要求
控制器
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.