1范围本特殊标准规定了第2.1.101和2.1.102款中定义的心脏除颤器和心脏除颤器监测器（以下简称设备）的安全要求，包括电容储能装置，其设计安装和使用符合加拿大电气规范的规则，第一部分:本标准不适用于不属于除颤器监护仪一部分的心脏监护仪。在无法通过除颤器电极获得ECG监测信号的组合设备中，本标准仅适用于除颤器部件。本特定标准的要求是CSA标准CAN/CSA-C22的补充要求。2第601.1号，医用电气设备，第1部分:安全通用要求，以下简称通用标准。 为了测试和批准本特定标准范围内的设备，设备必须首先满足C22的所有要求。2 No.601.1（如适用），然后满足本特定标准中规定的附加要求。本特殊标准不包括自动植入式除颤器、自动或顾问性体外除颤器或电话遥控除颤器等特殊设备，因为它们具有超出本特殊标准范围的特殊功能和操作模式。在本特定标准中，“应”表示强制性要求；“宜”表示建议，或建议但非强制性的建议。本标准包含加拿大偏差和编辑变更。

1ScopeThis Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS and CARDIAC DEFIBRILLATOR-MONITORS as defined in Sub-clauses 2.1.101 and 2.1.102, hereinafter referred to as EQUIPMENT, incorporating a capacitive energy storage device and which are designed to be installed and used in ac cordance with the Rules of the Canadian Electrical Code, Part I.This Standard does not apply to a CARDIAC MONITOR which is not part of a DEFIBRILLATOR-MONITOR.In combined EQUIPMENT in which the ECG monitoring signal cannot be derived via the DEFIBRILLATOR ELECTRODES, this Standard applies to the DEFIBRILLATOR part only.The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electri cal Equipment, Part 1: General Requirements for Safety, hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the Scope of this Particular Standard, the EQUIPMENT must first meet all the requirements of C22.2 No. 601.1, as applicable, and then meet the additional requirements stated in this Particular Standard.Special devices such as automatic implantable DEFIBRILLATORS, automatic or advisory external DEFIBRILLATORS, or telephone remote-controlled DEFIBRILLATORS, are not covered in this Particular Standard as they have special features and modes of operatio n which are beyond the Scope of this Particular Standard.In this Particular Standard, ""shall"" indicates a mandatory requirement; ""should"" indicates a recommendation, or that which is advised but not mandatory.Canadian Deviations and Editorial Changes are included in this Standard.