CSA序言这是CSA C22的第一版。2第80601-2-49号，医用电气设备-第2-49部分:多功能患者监护仪基本安全和基本性能的特殊要求，采用了相同名称的IEC（国际电工委员会）标准80601-2-49（第一版，2018-03），但存在加拿大偏差。它是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。为简洁起见，本标准通篇称为“CSA C22.2 No.80601-2-49”。本标准拟与CAN/CSA-C22结合使用。2 No.60601-1:14，医用电气设备-第1部分:基本安全和基本性能的一般要求（采用IEC 60601- 1:2005，包括修正案1:2012，带有加拿大偏差）。本标准适用于本标准规定范围内的合格评定。本标准由CSA消费品和商业产品技术委员会审查，以供加拿大采用，由CSA电气安全要求战略指导委员会管辖，并已由技术委员会正式批准。由于本标准的医疗内容，本标准还得到了CSA健康与福利战略指导委员会管辖下的CSA医疗保健用电技术委员会的批准。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。 CSA集团已将其作为加拿大国家标准发布。范围和目标通用标准1第1条适用，但以下情况除外:201.1.1*范围更换: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装置的单个患者。 注:在本文件中，孕妇及其胎儿被视为一名患者。本文件未规定ECG、有创血压和脉搏血氧饱和度等单独生理监测装置的要求。与这些生理监测装置相关的特殊标准从独立医用电气设备的角度规定了要求。本特定标准阐述了与多功能患者监护仪相关的附加要求。多功能患者监护仪可以集成到其他医用电气设备或医疗电气系统中。在这种情况下，其他相关标准也适用。示例1将多功能患者监护仪整合到重症监护呼吸机中，ISO 80601- 2-12也适用。例2:ISO 80601-2-72也适用于家庭护理呼吸机中的多功能患者监护仪。例3多功能病人监护仪并入麻醉工作站，ISO 80601-2-13也适用。例4:纳入血液透析设备的多功能患者监护仪，IEC 60601-2-16也适用。本文件不适用于多功能患者监护仪的可植入部件。201.1.2对象更换:本特定标准的目的是为201.3.201中定义的多功能患者监护仪制定基本安全和基本性能要求。

CSA PrefaceThis is the first edition of CSA C22.2 No. 80601-2-49, Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-49 (first edition, 2018-03). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CSA C22.2 No. 80601-2-49" throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.Scope and objectClause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: 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. This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply.EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies.EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT where ISO 80601-2-72 also applies.EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies.EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also applies. This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS. 201.1.2 Object Replacement: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201.