Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO/DIS 10651-4:2021); German and English version prEN ISO 10651-4:2021 / Note: Date of issue 2021-07-09*Intended as replacement for DIN EN ISO 10651-4 (2009-08).
1Key Takeaways
This document specifies requirements for user-powered resuscitators for use in all age groups, intended to provide ventilation of the lungs of patients who are inadequately breathing. User-powered resuscitators are specified according to ideal weight ranges. NOTE 1: Patients treated with a resuscitator may be ventilato…
2Scope / Description
This document specifies requirements for user-powered resuscitators for use in all age groups, intended to provide ventilation of the lungs of patients who are inadequately breathing. User-powered resuscitators are specified according to ideal weight ranges. NOTE 1: Patients treated with a resuscitator may be ventilator-dependent. Example user-powered resuscitators include:
——self-inflating bag resuscitators, intended to be squeezed by the user's hand and re-inflated by elastic recoil; NOTE 2: Self-inflating bag resuscitators may typically be used in transport. - flow-inflating bag resuscitators, intended to be squeezed by the user's hand and re-inflated by the flow of a source of medicinal gas. This document also applies to accessories intended for use with a resuscitator, the characteristics of which may affect the safety of the user-powered resuscitator. Examples of such accessories include masks, PEEP valves, CO2 indicators, pressure gauges, metronomes, flow restrictors, filters, gas refill valves, oxygen mixers, connectors, point-of-use packaging, electronic feedback devices, electronic sensors, and data transfer to other equipment. This document does not specify requirements for the following devices:
——gas-powered emergency resuscitators, see ISO 10651-5 [8];
——electrically powered resuscitators;
——gas-powered resuscitators for professional healthcare use;
——anaesthetic reservoir bags, see ISO 5362 [4]. NOTE 3 This document is intended to address the relevant International Medical Device Regulators Forum (IMDRF) fundamental principles [22] and labelling [23] guidance, as shown in Annex D. NOTE 4 This document is intended to address the relevant safety and performance fundamental principles of ISO 16142-1:2016 [11], as shown in Annex E. NOTE 5 This document is intended to address the relevant general safety and performance requirements of European Regulation (EU) 2017/745 [21], as shown in Annex F.