NF EN ISO 80601-2-84, S95-186-2-84 (11/2023)

This document applies to the basic safety and essential performance of an EMS ventilator associated with its accessories, hereinafter referred to as EM device: ¾ intended for patients requiring different levels of artificial ventilation support, including to ventilator-dependent patients; ¾ intended for use by a professional healthcare operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator may also be used during transport to a professional healthcare facility. An EMS ventilator is not intended to use a closed-loop physiological control system unless it uses a patient physiological variable to adjust artificial ventilation therapy parameters. This document also applies to accessories designed by their manufacturer to be connected to the respiratory system of the ventilator, or to an EMS ventilator, where the characteristics of these accessories may affect the basic safety and essential performance of the EMS ventilator. NOTE 3 If an article or paragraph is specifically intended to be applied only to EM devices or EM systems, the title and content of that article or paragraph will indicate this. Otherwise, the article or paragraph applies to both EM devices and EM systems, as applicable. Hazards inherent in the intended physiological function of EM devices or EM systems within the scope of this document are not covered by specific requirements contained in this document, with the exception of IEC 60601- 1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2 This document does not specify requirements applicable to: NOTE 5 See ISO/TR 21954 for guidance relating to the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in intensive care applications. These are given in ISO 80601-2-12; ¾ ventilators or accessories intended for ventilator-dependent patients in the home care environment. These are given in ISO 80601-2-72; ¾ ventilators or accessories intended for anesthesia applications. These are given in ISO 80601-2-13; ¾ ventilators or accessories intended for respiratory assistance equipment (only intended to increase the ventilation of spontaneously breathing patients). These are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ EM devices for treating sleep apnea. These are given in ISO 80601-2-70; ¾ resuscitators with manual motor power. These are given in ISO 10651-4; ¾ gas-powered emergency resuscitators. These are given in ISO 10651-5; ¾ EM continuous positive airway pressure (CPAP) machines; ¾ high frequency jet fans (VJHF). These are given in ISO 80601-2-87; ¾ high frequency oscillation fans (VOHF) REF _Ref69393406 \r \h \* MERGEFORMAT [44] 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F005200650066003600390033 00390033003400300036000000 . These are given in ISO 80601-2-87; NOTE 6 An SMU ventilator may incorporate high-frequency jet or high-frequency oscillation ventilation modes. ¾ high flow respiratory therapy equipment. These are given in ISO 80601-2-90; NOTE 7 An EMS ventilator may incorporate a high flow therapy mode of operation, but this mode is reserved for spontaneously breathing patients. ¾ EM devices delivering a constant flow of oxygen therapy; ¾ breastplates or “iron lungs”.
(Automatic translation from French)