规定了在医用电气设备和医用电气系统中，作为生理闭环控制系统（PCLCS）一部分的生理闭环控制器（PCLC）的开发（分析、设计、验证和验证）要求，以控制生理变量。 本附带标准适用于各种类型的PCLC，例如线性和非线性、自适应、模糊、神经网络。 本附带标准适用于闭环控制器，该控制器设置控制器输出变量，以便通过将测量的生理变量与参考变量关联来调整（即，改变或维持）测量的生理变量。

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.