NF EN ISO 80601-2-79, S95-186-2-79 (09/2024)

This document applies to the basic safety and essential performance of ventilatory assistance equipment, as defined in 201.3.205, for ventilatory disorder, as defined in 201.3.202, hereinafter also referred to as devices em, in combination with their accessories: — intended for use in the home care environment; — intended for use by a non-specialist operator; and — intended for use with patients suffering from a ventilatory disorder, the most fragile of these patients having little risk of being injured in the event of loss of this artificial ventilation; and — not intended for use in patients whose immediate maintenance of vital functions depends on artificial ventilation. EXAMPLE 1 Patients suffering from mild to moderate chronic obstructive pulmonary disease (COPD). NOTE 1 In the home care environment, it is common for the power supply to be unreliable. NOTE 2 This ventilatory assistance equipment can also be used in professional healthcare establishments, for applications other than intensive care. This document also applies to accessories designed by their manufacturer to be connected to the respiratory system of ventilatory assistance equipment in the event of a ventilatory disorder, when the characteristics of these accessories may affect the basic safety or essential performance of the equipment. Ventilatory assistance in the event of a ventilatory disorder. EXAMPLE 2 Respiratory assemblies, connectors, water traps, exhalation valve, humidifier, filter for respiratory system, external electrical power source and distributed alarm system. If an article or paragraph is specifically intended to be applicable only to em devices or only to em systems, the title and content of that article or paragraph indicate so. 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, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This document does not specify requirements for: — ventilators or accessories for ventilator-dependent patients intended for intensive care applications, which are given in ISO 80601-2-12; — ventilators or accessories intended for anesthesia applications, which are given in ISO 80601-2-13[4]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[5] [1]), which will replace ISO 10651-3[6]; — ventilators or accessories for ventilator-dependent patients in the home care environment, which are given in ISO 80601-2-72; — ventilatory assistance equipment or accessories provided in the event of ventilatory insufficiency, which are given in ISO 80601-2-80[1]; — sleep apnea treatment devices, which are given in ISO 80601-2-70[7]; — em devices delivering continuous positive airway pressure (CPAP); — high frequency jet fans (JVHF); — high frequency oscillation fans (VOHF)[8]; — em devices delivering a constant flow of oxygen therapy; — ventilation equipment of the armor or “iron lung” type. This document is part of the IEC 60601 and IEC/ISO 80601 series of documents. [1]) Under development. Status at the time of publication: ISO/DIS 80601-2-84:2017.
(Automatic translation from French)