DANSK DSF/ISO/FDIS 80601-2-84 PDF

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an EM S VENTILATOR in combination with its ACCESSORIE S, hereafter also referred to as ME EQUIPMENT, intended: ¾ for PATIENTS who need differing levels of support from artificial ventilation including for VENTILATOR-DE PENDENT PATIENTS; ¾ for use in the EMS ENVIRONME NT; and ¾ for invasive or non-invasive ventilation. NOTE 1 – An EMS VENTILATOR can also be used for transport within a PROFESSIONAL HEALTHCARE FACILITIES. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BRE ATHING SYSTEM of an E MS VENTILATOR, or to an E MS VENTILATOR, where the characteristics of those ACCESSORIE S can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the EM S VENTILATOR. If a clause or subclause is specifically intended to be applicable to M E E QUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTE MS, as relevant. HAZARDS inherent in the intended physiological function of ME E QUIPMENT or M E SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 2 – Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This part of ISO 80601 does not specify the requirements for ¾ VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in critical care applications, which are given in ISO 80601-2-12 [3]. ¾ VENTILATORS or ACCESSORIES intended for VE NTILATOR-DEPENDE NT PATIENTS in the HOME HEALTHCARE ENVIRONMENT, which are given in ISO 80601-2-72 [ 4]. ¾ VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601-2-13 [5 ]. ¾ VENTILATORS or ACCESSORIES intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7].