ISO 80601-2-87:2021 医用电气设备 第2-87部分：高频呼吸机基本安全和基本性能的特殊要求

标准编号：ISO 80601-2-87:2021

中文名称：医用电气设备 第2-87部分：高频呼吸机基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

发布日期：2021-04

标准范围

本文件适用于高频呼吸机（HFV）及其附件（以下简称ME设备）的基本安全和基本性能:-拟用于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门护理的环境中；注1就本文件而言，此类环境称为重症监护环境。用于这种环境的高频呼吸机被认为是维持生命的。注2:出于本文件的目的，这种高频呼吸机可以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高频呼吸机不视为拟用于紧急医疗服务环境的呼吸机。-拟由医疗保健专业人员操作；-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；和-能够提供超过150次充气/分钟。HFV有三种主要名称:-高频冲击通气[HFPV，典型HFV频率为(60至1000)HFV充气/分钟]；-高频喷射通气[HFJV，典型HFV频率为(100至1500)HFV充气/min]；和-高频振荡通气[HFOV，典型HFV频率为(180至1200)个HFV充气/分钟，并且通常具有主动呼气期]。此外，HFV名称可以组合在一起或与速率小于150次充气/分钟的通气组合。*高频呼吸机不被视为生理闭环控制系统，除非其使用生理患者变量来调整通气治疗设置。本文件也适用于制造商打算连接到HFV呼吸系统或高频呼吸机的附件，其中这些附件的特性会影响高频呼吸机的基本安全性或基本性能。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，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。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不在本文件的具体要求范围内，第7条除外。IEC 60601-1:20 05的2.13和8.4.1。注4其他信息见IEC 60601-1:20 05+AMD1:2012的4.2。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:-ISO 80601-2-12[23]中给出的为重症监护环境提供常规通风的非高频呼吸机或附件；注5 HFV可包含常规重症监护呼吸机操作模式，在这种情况下，ISO 80601-2-12适用于这些模式。-用于麻醉应用的呼吸机或附件，其在ISO 80601-2-13[24]中给出；-ISO 80601中规定的用于紧急医疗服务环境的呼吸机或附件-2-84，ISO 10651-3的替代品[13]；注6:HFV可包含EMS呼吸机功能。-用于家庭医疗环境中依赖呼吸机的患者的呼吸机或附件，ISO 80601-？2-72[26];-用于家庭护理通气支持设备的呼吸机或附件，其在ISO 80601-2-79[27]和ISO 80601-2-80[28]中给出，ISO 10651-6[15]的替代品；-睡眠呼吸暂停呼吸治疗ME设备，其在ISO 80601-2-70[25]中给出；-双水平气道正压通气（双水平PAP）ME设备；-持续气道正压通气(CPAP)ME设备；-ISO 80601-2-90中给出的呼吸高流量ME设备？-1);和-胸甲还是？铁肺？通风本文件是IEC 60601系列、IEC 80601系列和ISO 80601系列中的特定标准。1）准备中。发布时的阶段:ISO/DIS 80601-2-90:2020。

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) 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. High-frequency ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).
NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.
- intended to be operated by a healthcare professional operator;
- intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
- capable of providing more than 150 inflations/min.
There are three principal designations of HFV:
- high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];
- high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and
- high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].
Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.
*A high-frequency ventilator is not considered 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 an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.
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 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.
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:
- non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO 80601-2-12 [23];.
NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601-2-12 is applicable to those modes.
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [24];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84, the replacement for ISO 10651-3 [13];
NOTE 6 An HFV can incorporate EMS ventilator capability.
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-？2-72 [26];
- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 [27] and ISO 80601-2-80 [28], the replacements for ISO 10651-6 [15];
- sleep apnoea breathing therapy ME equipment, which are given in ISO 80601-2-70 [25];
- bi-level positive airway pressure (bi-level PAP) ME equipment;
- continuous positive airway pressure (CPAP) ME equipment;
- respiratory high-flow ME equipment, which are given in ISO 80601-2-90？-1); and
- cuirass or？iron-lung？ventilation
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.
1) Under preparation. Stage at the time of publication: ISO/DIS 80601-2-90:2020.

标准预览图