ISO 80601-2-12:2011 医用电气设备 第2-12部分：危重护理呼吸机的基本安全和基本性能专用要求

标准编号：ISO 80601-2-12:2011

中文名称：医用电气设备 第2-12部分：危重护理呼吸机的基本安全和基本性能专用要求

英文名称：Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

发布日期：2011-04

标准范围

ISO 80601-2-12:2011适用于呼吸机及其附件（以下简称医用电气设备）的基本安全和基本性能:-拟由专业操作员为依赖机械通气的患者提供护理；和-用于专业医疗设施中的重症监护环境或用于专业医疗机构中的运输。ISO 80601-2-12:2011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影响呼吸机的基本安全或基本性能。ISO 80601-2-12:2011不适用于在通风模式下运行的医用电气设备或医用电气系统，该模式适用于不依赖机械通风的患者。ISO 80601-2-12:2011不适用于医用电气设备或医用电气系统，适用于不依赖机械通气的患者。如果某一条款或子条款旨在仅适用于医用电气设备或医用电气系统，则该条款或子条的标题和内容应如此。如果情况并非如此，则该条或子条款适用于医用电子设备和医用电气系统（视情况而定）。ISO 80601-2-12:2011不适用于持续气道正压通气（CPAP）医用电气设备、睡眠呼吸暂停治疗医用电气设备，家庭医疗环境呼吸机，呼吸机支持医用电气设备和紧急和运输呼吸机，麻醉呼吸机-频率喷射呼吸机（HFJVs）和高频振荡呼吸机（HFOVs）。ISO 80601-2-12:2011未规定医用电气设备的要求，该设备仅用于增强专业医疗机构内自主呼吸患者的通风。ISO 80601-2-12:2011没有规定ISO 80601-1-13中给出的用于麻醉应用的呼吸机或附件的要求。ISO 80601-2-12:2011没有规定ISO 10651-2中规定的用于呼吸机依赖患者家庭护理呼吸机的呼吸机或附件的要求。ISO 80601-2-12:2011没有规定ISO 10651中给出的紧急和运输用通风机或附件的要求-3.ISO 80601-2-12:2011没有规定ISO 10651-6中给出的用于家庭护理呼吸机支持设备的呼吸机或附件的要求。

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.

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