標準號：BS EN 60601-1-10-2008
中文標準名稱：醫用電氣設備.基本安全和基本性能的一般要求.補充標準.物理閉環控制器開發的要求
英文標準名稱：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
標準類型：C37
發布日期：2008/8/29 12:00:00
實施日期：2008/8/29 12:00:00
中國標準分類號：C37
國際標準分類號：11.040.01
引用標準：IEC 60601-1-2005;IEC 60601-1-6-2006;IEC 60601-1-8-2006;IEC 62304-2006;ISO 14971
適用范圍：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.