BS EN 60601-1-10-2008 医用电气设备.基本安全和基本性能的一般要求.补充标准.物理闭环控制器开发的要求

标准号：BS EN 60601-1-10-2008
中文标准名称：医用电气设备.基本安全和基本性能的一般要求.补充标准.物理闭环控制器开发的要求
英文标准名称：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
标准类型：C37
发布日期：2008/8/29 12:00:00
实施日期：2008/8/29 12:00:00
中国标准分类号：C37
国际标准分类号：11.040.01
引用标准：IEC 60601-1-2005;IEC 60601-1-6-2006;IEC 60601-1-8-2006;IEC 62304-2006;ISO 14971
适用范围：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofMEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to asME 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 aPHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS tocontrol 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; or− additional electrical requirements.This collateral standard applies to a closed-loop controller (see Figure 1) that sets theCONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measuredPHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that isnot measured from a PATIENT, is outside the scope of this standard.