ISO 80601-2-12:2020 医用电气设备 第2-12部分：危重监护用通风机基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-12:2020

中文名称：医用电气设备 第2-12部分：危重监护用通风机基本安全和基本性能的特殊要求

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：2020-02

标准范围

本文件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:旨在为病情可能危及生命且可能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中使用；注1就本文件而言，此类环境称为重症监护环境。这种环境下的呼吸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机构内提供运输（即是可运输操作的呼吸机）。注3:拟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医疗服务环境呼吸机。拟由医疗保健专业运营商运营；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。除非重症监护呼吸机使用生理患者变量来调整通气治疗设置，否则不认为其使用生理闭环控制系统。本文件也适用于制造商打算连接到呼吸机呼吸系统或呼吸机的附件，其中这些附件的特性会影响呼吸机的基本安全性或基本性能。注4:如果某条款或子条款特别打算仅适用于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。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。除IEC 60601-1:20 05、7.2.13和8.4.1外，本文件中的具体要求未涵盖本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害。注5其他信息见IEC 60601-1:20 05+AMD1:2012,4.2。本文件不适用于仅用于不依赖人工通气的患者的在呼吸机操作模式下运行的ME设备或ME系统。注6重症监护呼吸机在这种呼吸机操作模式下运行时，不被视为维持生命。本文件不适用于仅用于增强专业医疗机构内自主呼吸患者通气的ME设备。本文件未规定以下方面的要求:用于麻醉应用的呼吸机或附件，在ISO 80601-2-13[2]中给出；用于紧急医疗服务环境的呼吸机或附件，在ISO 80601-2-84[3]中给出，ISO 10651-3[4]的未来替代品；ISO 80601中规定的用于家庭医疗环境中依赖呼吸机的患者的呼吸机或附件？2-72:2015[5];用于家庭护理通气支持设备的呼吸机或附件，在ISO 80601-2-79:2018[6]和ISO 80601-2-80:2018[7][1]中给出；阻塞性睡眠呼吸暂停治疗设备，在ISO 80601？2？70[9];持续气道正压通气（CPAP）ME设备；高频喷射通风机（HFJV）和高-频率振荡呼吸机（HFOV），在ISO 80601？2？87[63];注7重症监护呼吸机可结合高频喷射或高频振荡呼吸机操作模式。氧疗恒流ME设备；和胸甲或“铁肺”通风设备。[1]ISO 80601-2-79和ISO 80601-2-80取代已撤销的ISO 10651-6。

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.

[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

标准预览图