80601国际标准的本部分适用于201.3.201中定义的多功能患者监护仪（以下简称医用电气设备或医疗电气系统）的基本安全和基本性能要求。本特殊标准适用于专业医疗机构、紧急医疗服务环境或家庭医疗环境中使用的多功能患者监护仪。 本文件的范围仅限于医用电气设备或医用电气系统 用于连接具有两个或多个生理监测的单个患者 单位。 注:在本文件中，孕妇及其胎儿被视为一名患者。交叉引用:IEC 60601-2-2:2017EN IEC 60601-2-2:2018EN 60601-2-27:2014EN 60529:1991EN 60601-1:2006/A11:2011IEC 60529:1989对比版2-1EN 60601-1-6:2010IEC 60601-1-12:2014EN 60601- 2007年10:10 10 10:10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 2015IEC 60601-2-16EN IEC 60601-2-16ENISO 80601-2-56ISO 80601-2-72EN ISO 80601-2-72ISO 80601-2-56ISO 80601-2-13EN ISO 80601-2-13购买本文件时提供的所有现行修订版均包含在购买本文件中。

This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS. NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.Cross References:IEC 60601-2-2:2017EN IEC 60601-2-2:2018EN 60601-2-27:2014EN 60529:1991EN 60601-1:2006/A11:2011IEC 60529:1989 Cons Ed 2-1EN 60601-1-6:2010IEC 60601-1-12:2014EN 60601-1:2006/A12:2014IEC 60601-1-6:2010EN 60601-1-8:2007/A11:2017EN 60601-1-2:2015IEC 60601-1-2:2014IEC 60601-1-11:2015EN 60601-1:2006IEC 60601-1:2005EN 60601-2-34:2014IEC 60601-2-27:2011EN 60601-1-8:2007/corrigendum Mar. 2010IEC 60601-2-34:2011EN 60601-1-8:2007IEC 60601-1-8:2006EN 60601-1:2006/A1:2013EN 60601-1:2006/corrigendum Mar. 2010EN 62366-1:2015IEC 62366-1:2015IEC 60601-2-16EN IEC 60601-2-16EN ISO 80601-2-56ISO 80601-2-72EN ISO 80601-2-72ISO 80601-2-56ISO 80601-2-13EN ISO 80601-2-13All current amendments available at time of purchase are included with the purchase of this document.