前言:这是CAN/CSA-C22的第一版。2第60601-1-10号，医用电气设备-第1-10部分:基本安全和基本性能的一般要求-附带标准:生理闭环控制器的开发要求，未经修改采用同名IEC（国际电工委员会）标准60601-1-10（第一版，2007-11）。这是CSA根据《加拿大电气规范》第二部分发布的一系列标准之一。1.1范围:本国际标准适用于医用电气设备和医用电气系统（以下简称医用电气设备和医用电气系统）的基本安全和基本性能。本附带标准规定了生理封闭系统的开发（分析、设计、验证和确认）要求- 回路控制器（PCLC）是医用电气设备和医用电气系统中生理闭环控制系统（PCLCS）的一部分，用于控制生理变量。注:生理变量可以是身体化学（例如电解质、血糖）、物理性质（例如患者温度、电生理、血流动力学）或药物浓度。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。本附带标准未规定:附加机械要求；或其他电气要求。本附带标准适用于闭环控制器（见图1），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（即改变或保持）测量的生理变量。 使用非患者测量的反馈来维持物理或化学变量的闭环控制器不在本标准的范围内。1.2目的本附属标准的目的是规定除通用标准外的一般要求，并作为特定标准的基础。1.3相关标准1。3.1 IEC 60601-1对于医用电气设备和医用电气系统，本附带标准是对IEC 60601-1的补充。当单独或结合引用IEC 60601-1或本附属标准时，使用以下约定:“通用标准”仅指定IEC 60601-1；“本附属标准”仅指定IEC 60601-1-10；“本标准”是指一般标准和本附带标准的组合。

Preface:This is the first edition of CAN/CSA-C22.2 No. 60601-1-10,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, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-10 (first edition, 2007-11). It is one in a series of Standards issued by CSA under Part II of theCanadian Electrical Code.1.1 Scope:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.This collateral standard 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 ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE.NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.This collateral standard does not specify:additional mechanical requirements; oradditional electrical requirements.This collateral standard applies to a closed-loop controller (see Figure 1) 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.A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard.1.2 ObjectThe object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.1.3 Related standards1.3.1 IEC 60601-1For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used:"the general standard" designates IEC 60601-1 alone;"this collateral standard" designates IEC 60601-1-10 alone;"this standard" designates the combination of the general standard and this collateral standard.