NF EN ISO 10651-4, S95-160-4 (06/2023)

This document specifies requirements for user-operated resuscitators intended for use in all age groups and designed to provide pulmonary ventilation to patients with insufficient breathing. User-operated resuscitators are designed based on an ideal body weight range. Here are some examples of user-operated resuscitators: — self-filling balloon resuscitators intended to be manually squeezed by the user and refilled by springback; and NOTE 1 Self-filling balloon resuscitators are generally operational on the move and can be used in a multitude of environmental and emergency situations. — flow-inflating bag resuscitators intended to be manually squeezed by the user and refilled using a flow from a medical gas source. This document is also applicable to accessories intended for use with resuscitators where the characteristics of these accessories may affect the safety of the resuscitator operated by the user. Face masks, PEEP valves, capnometric indicators, pressure gauges, metronomes, flow reducers, filters, gas filling valves, gaseous oxygen mixers, fittings, electronic feedback devices, Electronic sensors and data transmission to other equipment are examples of accessories of this type. This document is also applicable to point-of-use packaging. This document does not specify requirements for: — gas-powered emergency resuscitation devices, which are presented in ISO 10651-5; — electric resuscitators; — gas-powered resuscitators for professional care establishments; and — anesthesia reservoir bags, which are presented in ISO 5362. NOTE 2 This document has been prepared to cover the essential principles[24] and labeling recommendations[25] of the International Medical Devices Regulators Forum (IMDRF) as set out in Annex D. NOTE 3 This document has been developed to address the relevant safety and performance essential principles of ISO 16142-1:2016, as set out in Annex E. NOTE 4 This document has been developed to address the relevant general safety and performance requirements of European Regulation (EU) 2017/745,[23] as set out in Annex F.
(Automatic translation from French)