BS EN ISO 10651-4:2023 - Page 2

Lung ventilators. Particular requirements for user-powered resuscitators | Status: Current

1 Scope 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.