DANSK DSF/ISO/FDIS 80601-2-79 PDF

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.204, for VE NTILATORY IMPAIRMENT, as defined in 201.3.201, hereafter also referred to as ME EQUIPM ENT, in combination with its ACCESSORIES: – intended for use in the HOME HEALTHCARE ENVIRONME NT; – intended for use by a LAY OPERATOR; and – intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, but who are not dependent on mechanical ventilation for their life support. EXAMPLES 1 PAT IE NTS with mild to mo derate chron ic obstructive pulmonary disease (COPD). NOTE 1 – In the H OM E HE AL TH CARE E N VIR ONM E NT , the S U PPL Y M A I NS is often not reliable. NOTE 2 – Such VE NT IL ATO RY S UP PORT E QU IPM E NT can also be use d in non-critical care a pplications of profession al health care facilities. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to the BRE ATHING SYSTEM of VENTILATORY SUPPORT EQUIPME NT for VENTILATORY IMPAIRMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT. EXAMPLES 2 Breathing sets, conn ectors, water traps, expiratory valve, HU M IDIFIE R, B RE AT HI NG SYST EM F IL T ER, external electrical power so urce, DIST RIB U TE D AL A RM S YST E M . 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+AMD1:2012, 7.2.13 and 8.4.1.