医疗电气设备.第2-12部分:急救护理呼吸机的基本安全性和本质性能的详细要求

[中文适用范围]： IEC 60601-1:2005 的第 1.1 款第 1 款替换为： 本国际标准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：  旨在由为依赖机械通气的患者提供专业操作员；注 1：此类呼吸机被视为生命支持 ME 设备或 ME 系统。  旨在用于专业医疗机构的重症监护环境或用于专业医疗机构内的运输。 注 2：用于专业医疗机构内运输的重症监护呼吸机不被视为紧急和运输呼吸机。 本国际标准也适用于制造商打算连接到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。 本国际标准不适用于在通气模式下运行的 ME 设备或 ME 系统，适用于不依赖机械通气的患者。 注 3：重症监护呼吸机在这种模式下运行时，不被视为生命支持 ME 设备或 ME 系统。 如果某条款或子条款专门旨在仅适用于 ME 设备或仅适用于 ME 系统，则该条款或子条款的标题和内容将如此说明。 如果情况并非如此，则该条款或子条款适用于相关的 ME 设备和 ME 系统。 除 IEC 60601-1:2005、7.2.13 和 8.4.1 外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。 注 4：更多信息可参见 IEC 60601-1:2005, 4.2。 本国际标准不适用于持续气道正压通气（CPAP）ME设备、睡眠呼吸暂停治疗ME设备、家庭医疗保健环境呼吸机、通气支持ME设备、急救和转运呼吸机、麻醉呼吸机、高频喷射呼吸机（HFJV）和高频振荡呼吸机 (HFOV)。 [26]本国际标准未规定对仅用于增强专业医疗机构内自主呼吸患者通气的 ME 设备的要求。 本国际标准没有规定 ISO 80601-2-13 中给出的用于麻醉应用的呼吸机或配件的要求。 本国际标准没有规定 ISO 10651-2 1) 中给出的用于依赖呼吸机的患者的家庭护理呼吸机的呼吸机或配件的要求。 本国际标准没有规定 ISO 10651-3 2) 中给出的用于紧急情况和运输的呼吸机或附件的要求。 本国际标准没有规定 ISO 10651-6 3) 中给出的用于家庭护理通气支持装置的呼吸机或配件的要求。 [外文原描述]： ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. 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. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.