CSA序言这是CAN/CSA-C22的第一版。2第80601-2-72号，医用电气设备-第2-72部分:呼吸机依赖患者家庭医疗环境呼吸机基本安全和基本性能的特殊要求，采用了同名ISO（国际标准化组织）标准80601-2-72（第一版，2015-09-01）。它取代了CAN/CSA-Z10651-2:06《医用肺呼吸机-基本安全和基本性能的特殊要求-第2部分:呼吸机依赖患者的家庭护理呼吸机》（采用ISO 10651-2:2004）。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“CAN/CSA-C22.2编号80601-2-72”。本标准拟与CAN/CSA-C22结合使用。2编号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，包括修改件1:2012，带有加拿大偏差）和CAN/CSA-C22。2 No.60601-1-11:15，医用电气设备-第1-11部分:基本安全和基本性能的一般要求-附带标准:家庭医疗环境中使用的医用电气设备和医用电气系统的要求（采用IEC 60601-1-11:2015，有加拿大偏差）。范围和目标EC 60601-1:2005+AMD1:2012，第1条适用，但以下情况除外:201.1.1*范围IEC 60601-1:2005+AMD1:2012，1.1替换为:ISO 80601的本部分适用于呼吸机及其附件（以下简称ME设备）的基本安全和基本性能:-用于家庭医疗环境供非专业操作人员使用；-适用于依赖机械通气维持生命的患者。 注1:此类呼吸机也可用于不依赖呼吸机支持的患者。注2:在家庭医疗环境中，驱动呼吸机的动力通常不可靠。注3:此类呼吸机也可用于专业医疗机构的非重症监护应用。ISO 80601的本部分也适用于制造商计划连接到呼吸机呼吸系统或呼吸机的附件，这些附件的特性可能会影响呼吸机的基本安全或基本性能。例如呼吸管、连接器、存水弯、呼气阀、加湿器、呼吸系统过滤器、外部电源和分布式报警系统。如果某一条款或子条款明确规定仅适用于医用电气设备或医用电气系统，则该条款或子条款的标题和内容应如此说明。如果情况并非如此，则本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。 除IEC 60601-1:2005+AMD1:2012、7.2.13和8.4.1外，ISO 80601本部分的具体要求未涵盖ISO 80601范围内医用电气设备或医用电气系统预期生理功能的固有危险。注4:更多信息见IEC 60601-1:2005+AMD1:2012，4.2。ISO 80601的本部分不适用于持续气道正压通气（CPAP）医用电气设备、高频喷射通气机（HFJV）和高频振荡通气机（HFOV）[35]。ISO 80601的本部分未规定铁甲和“铁肺”呼吸机的要求。ISO 80601的这一部分没有规定用于重症监护应用的呼吸机或附件的要求，这些要求在ISO 80601-2-12中给出。ISO 80601的本部分未规定用于2？的通风机或附件的要求？ISO 2015-保留所有权利的麻醉应用，见ISO 80601- 2-13. ISO 80601的本部分未规定ISO 10651-3中规定的应急和运输用通风机或附件的要求。注5:未来，ISO 10651-3预计将与IEC 60601-1:2005协调，届时将被ISO 80601-2-xx取代。ISO 80601的本部分未规定ISO 10651-6中规定的家用护理通气支持设备（仅用于增强自主呼吸患者的通气）的呼吸机或附件的要求。注6:未来，ISO 10651-6预计将与IEC 60601-1:2005和IEC 60601-1-11:2015相协调，届时将被ISO 80601-2-xx取代。ISO 80601的本部分未规定ISO 80601-2-70中给出的阻塞性睡眠呼吸暂停治疗医用电气设备的要求。[16] ISO 80601的这一部分是IEC 60601-1和ISO/IEC 80601系列标准中的特定国际标准。 201.1.2目标IEC 60601-1:2005+AMD1:2012，1.2替换为:ISO 80601本部分的目标是确定201.3.217中定义的呼吸机及其附件的特殊基本安全和基本性能要求。注:包括附件是因为呼吸机和附件的组合需要足够安全。配件可能对呼吸机的基本安全或基本性能产生重大影响。

CSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 80601-2-72, Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-72 (first edition, 2015-09-01). It replaces CAN/CSA-Z10651-2:06, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator dependent patients (adopted ISO 10651-2:2004). 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 "CAN/CSA-C22.2 No. 80601-2-72" 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) and CAN/CSA-C22.2 No. 60601-1-11:15, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (adopted IEC 60601-1-11:2015, with Canadian deviations).Scope and objectIEC 60601-1:2005+AMD1:2012, Clause 1 applies, except as follows: 201.1.1 *Scope IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended for use in the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; - intended for use with PATIENTS who are dependent on mechanical ventilation for their life support. NOTE 1 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support. NOTE 2 In the HOME HEALTHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable. NOTE 3 Such VENTILATORS can also be used in non-critical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, and DISTRIBUTED ALARM SYSTEM. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, high-frequency jet ventilators (HFJVs), and high-frequency oscillatory ventilators (HFOVs)[35]. This part of ISO 80601 does not specify the requirements for cuirass and "iron-lung" VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601-2-12. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for 2?ISO 2015 - All rights reserved anaesthetic applications, which are given in ISO 80601-2-13. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3. NOTE 5 In the future, ISO 10651-3 is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 10651-6. NOTE 6 In the future, ISO 10651-6 is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2015, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70.[16] This part of ISO 80601 is a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. 201.1.2 Object IEC 60601-1:2005+AMD1:2012, 1.2 is replaced by: The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a VENTILATOR.