NF EN ISO 80601-2-12, S95-186-2-12 (11/2023)

This document applies to the basic safety and essential performance of an intensive care ventilator associated with its accessories, hereinafter referred to as EM device: ¾ intended for use in an environment that provides specialized patient care whose state of health may be life-threatening and who may require comprehensive care and constant monitoring in a professional care facility; NOTE 2 For the purposes of this document, an environment of this nature is referred to as an “intensive care environment”. Fans for such an environment are considered essential for sustaining life. NOTE 3 For the purposes of this document, such an intensive care ventilator can provide ventilation during transport within a professional healthcare setting (i.e. be an operational ventilator on the move). NOTE 4 An intensive care ventilator intended for use during transport within a professional health care facility is not considered a ventilator intended for use in the emergency medical services environment. ¾ intended for use by a professional healthcare operator; and ¾ intended for patients who require different levels of support with artificial ventilation, including ventilator-dependent patients. A ventilator for use in intensive care is not considered to use a closed-loop physiological control system unless it uses a patient physiological variable to adjust artificial ventilation treatment parameters. This document also applies to accessories designed by their manufacturer to be connected to the respiratory system of a ventilator or to a ventilator, where the characteristics of these accessories may affect the basic safety or essential performance of the ventilator. NOTE 5 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 this. If not, the article or paragraph applies to both EM devices and EM systems, as appropriate. 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 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+ AMD2:2020, 4.2. This document is not applicable to any ME device or ME system providing a ventilator mode of operation intended solely for patients not dependent on artificial ventilation. NOTE 7 When operating in such a ventilator mode of operation, a ventilator for use in intensive care is not considered essential for life support. This document does not apply to EM devices intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare setting. This document does not specify requirements for: NOTE 8 See ISO/TR 21954 for recommendations on choosing the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anesthesia applications, which are given in ISO 80601-2-13; ¾ ventilators or accessories intended for use in the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home care environment, which are given in ISO 80601-2-72; ¾ ventilators or accessories intended for home respiratory assistance devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ EM devices for the treatment of obstructive sleep apnea, which are given in ISO 80601-2-70; ¾ EM continuous positive airway pressure (CPAP) machines; ¾ high frequency fans, indicated in ISO 80601-2-87; NOTE 9 A ventilator for use in intensive care may incorporate the operating modes of a high-frequency jet fan or a high-frequency oscillation ventilator. ¾ high-flow respiratory treatment devices, which are given in ISO 80601-2-90; NOTE 10 A ventilator for use in intensive care may incorporate a high-flow treatment mode of operation, but such a mode is only intended for spontaneously breathing patients. ¾ EM oxygen therapy devices delivering a constant flow rate; and ¾ armor or “iron lung” type ventilation devices.
(Automatic translation from French)