医用肺通气机.第4部分:操作员控制的呼吸器的特殊要求

[中文适用范围]： 本文件规定了适用于所有年龄段的用户动力复苏器的要求，这些复苏器旨在为呼吸不足的患者提供肺部通气。 用户动力复苏器是根据理想体重范围指定的。 用户动力复苏器的示例包括： ——自充气袋复苏器，旨在由用户的手挤压并通过弹性反冲重新填充；注 1：自充气袋复苏器通常可运输，可用于各种环境和紧急情况。 — 流量充气袋复苏器，旨在由用户的手挤压并通过来自医用气体源的流量重新填充。 本文件还适用于那些旨在与复苏器一起使用的附件，其中这些附件的特性可能会影响用户供电的复苏器的安全。 此类配件的示例包括面罩、PEEP阀、二氧化碳监测指示器、压力计、节拍器、限流器、过滤器、气体再填充阀、氧气混合器、连接器、电子反馈装置、电子传感器和向其他设备传输数据。 本文件也适用于使用点包装。 本文件没有规定以下要求： ——ISO 10651-5 中给出的气动紧急复苏器； ——电动复苏器； ——用于专业医疗机构的燃气复苏器； ——ISO 5362 中给出的麻醉储液袋。 注 2：本文件的编写是为了解决附件 D 中所示的国际医疗器械监管机构论坛 (IMDRF) 的相关基本原则 [24] 和标签 [25] 指南注 3 本文件的编写是为了解决安全和性能的相关基本原则 注 4 本文件的编写是为了解决欧洲法规 (EU) 2017/745[23] 的相关一般安全和性能要求，如附件所示F。 [外文原描述]： This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks , PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651 - 5 ; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities ; and — anaesthetic reservoir bags, which are given in ISO 5362 . NOTE 2 This document has been prepared to address the relevant essential principles [ 24 ] and labelling [ 25 ] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D . NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142 - 1 : 2016 as indicated in Annex E . NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [ 23 ] as indicated in Annex F .