scope:

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in 270 combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: 271 - intended for use in the HOME HEALTHCARE ENVIRONMENT; 272 - intended for use by a LAY OPERATOR; 273 - intended for use with PATIENTS who are dependent on mechanical ventilation for their life support. 274 NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. 275 NOTE 2 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support. 276 NOTE 3 In the HOME HEALTHCARE ENVIRONMENT, the driving power is often not reliable. 277 NOTE 4 Such VENTILATORS can also be used in professional health care facilities. 278 This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be 279 connected to a VENTILATOR BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those 280 ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. 281 EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external 282 electrical power source, DISTRIBUTED ALARM SYSTEM 283 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, 284 the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause 285 applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 286 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of 287 this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005+A1:2012, 288 7.2.13 and 8.4.1. 289 NOTE 5 Additional information can be found in IEC 60601-1:2005+A1:2012, 4.2. 290 This particular standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep 291 apnoea therapy ME EQUIPMENT, critical care VENTILATORS, ventilatory support ME EQUIPMENT, emergency and 292 transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[33]