CSA序言这是CSA C22的第二版。2第80601-2-12号，医用电气设备-第2-12部分:重症监护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80601-2-12（第二版，2020-02），但存在加拿大偏差。它取代了2012年以CAN/CSA-C22发布的上一版本。2编号80601-2-12（采用ISO 80601-2-12:2011）。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。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第1条适用，以下情况除外:注通用标准为IEC 60601-1:2005+AMD1:2012。201.1.1*范围更换:本文件适用于呼吸机及其附件的基本安全和基本性能，以下简称医用电气设备:-用于为可能危及生命、需要在专业医疗机构进行全面护理和持续监测的患者提供专业护理的环境； 注1:在本文件中，这种环境被称为重症监护环境。这种环境下的通风机被认为是维持生命的。注2:就本文件而言，此类呼吸机可在专业医疗设施内提供运输（即，可运输的呼吸机）。注3:用于在专业医疗机构内运输的重症监护呼吸机不被视为紧急医疗服务环境呼吸机。-拟由医疗保健专业操作员操作；和-适用于需要不同程度人工通气支持的患者，包括依赖呼吸机的患者。重症监护呼吸机不考虑使用生理封闭式呼吸机- 回路控制系统，除非它使用患者生理变量来调整通气治疗设置。本文件也适用于制造商拟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。注4:如果某一条款或子条款明确规定仅适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容应如此规定。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外，本文件的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能中固有的危险- 1:2005，7.2.13和8.4.1。注5:更多信息见IEC 60601-1:2005+AMD1:2012，4.2。本文件不适用于医用电气设备或医用电气系统在呼吸机运行模式下运行，仅适用于不依赖人工通气的患者。注6:重症监护呼吸机在呼吸机运行模式下运行时，不被视为维持生命。本文件不适用于仅用于在专业医疗机构内增强自主呼吸患者通气的医用电气设备。本文件未规定ISO 80601中规定的用于麻醉应用的呼吸机或附件的要求- 2-13[2]; - ISO 80601-2-84[3]中给出的用于紧急医疗服务环境的呼吸机或配件，是ISO 10651-3[4]的未来替代品ISO 80601-2-72:2015[5]中给出的用于家庭医疗环境中依赖呼吸机的患者的呼吸机或配件ISO 80601-2-79:2018[6]和ISO 80601-2-80:2018[7]1中给出的用于家庭护理呼吸机支持设备的呼吸机或附件ISO 80601-2-70[9]中给出的阻塞性睡眠呼吸暂停治疗医用电气设备持续气道正压通气（CPAP）医用电气设备ISO 80601中给出的高频喷射式呼吸机（HFJV）和高频振荡式呼吸机（HFOV）- 2-87[63];注7重症监护呼吸机可包括高频喷射或高频振荡呼吸机操作模式。-氧疗恒流医用电气设备；和-铁甲或“铁肺”通风设备。201.1.2对象更换:本文件的目的是建立呼吸机及其附件的基本安全和基本性能要求。附件包括在内，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。注1:本文件旨在阐述ISO 16142安全和性能的相关基本原则- 1:2016，如附件CC所示。注2:本文件旨在解决附件DD中所示的欧洲法规（EU）2017/745的相关一般安全和性能要求。

CSA PrefaceThis is the second edition of CSA C22.2 No. 80601-2-12, Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-12 (second edition, 2020-02). It supersedes the previous edition, published in 2012 as CAN/CSA-C22.2 No. 80601-2-12 (adopted ISO 80601-2-12:2011). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.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 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 object Clause 1 of the general standard applies, except as follows:NOTE The general standard is IEC 60601-1:2005+AMD1:2012. 201.1.1 * Scope Replacement: This document 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 an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. - intended to be operated by a healthcare professional operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document 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.NOTE 4 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 document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.NOTE 5 Additional information can be found in IEC 60601-1:2005 +AMD1:2012, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2]; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4]; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72:2015[5]; - ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7] 1; - obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70[9]; - continuous positive airway pressure (CPAP) ME equipment; - high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[63];NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. - oxygen therapy constant flow ME equipment; and - cuirass or "iron-lung" ventilation equipment. 201.1.2 Object Replacement: The object of this document is to establish basic safety and essential performance requirements for a ventilator and its accessories. 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.NOTE 1 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex CC.NOTE 2 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 as indicated in Annex DD.