Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

2Scope / Description

This document applies to the basic safety and essential performance of sleep apnea therapy equipment, hereinafter referred to as me equipment, intended to relieve the symptoms of patients with obstructive sleep apnea by delivering therapeutic breathing pressures to the patient's airway. Sleep apnea therapy equipment is intended for use by lay operators in the home healthcare environment as well as by professional healthcare facilities. * A sleep apnea therapy equipment is not considered to use a physiological closed-loop control system unless it uses physiological patient variables to adjust the therapy settings. Sleep apnea therapy equipment for neonates is excluded from this document. This document applies to me equipment or me systems for patients who are not mechanically ventilated. This document does not apply to me equipment or me systems for patients who are mechanically ventilated, such as patients with central sleep apnea. This document also applies to accessories that the manufacturer intends to be connected to a sleep apnea therapy equipment, the characteristics of which may affect the basic safety or essential performance of the sleep apnea therapy equipment. Masks and applied accessories used during sleep apnea therapy are also specified by ISO 17510. See Figure AA.1 for the items covered by this document. If a clause or subclause applies specifically to a me equipment or me system, the title and content of that clause or subclause will state so. If this is not the case, the clause or subclause applies to both the ME EQUIPMENT and the ME SYSTEM. Hazards inherent in the intended physiological function of the ME EQUIPMENT or ME SYSTEM within the scope of this document are outside the scope of specific requirements of this document, with the exception of 7.2.13 and 8.4.1 of the general standard. This document does not apply to high frequency jet ventilators (HFJV) or high frequency oscillation ventilators (HFOV), which are specified in ISO 80601-2-87 [13]. This document does not specify requirements for critical care ventilators or accessories for use with ventilated patients, which are specified in ISO 80601-2-12. This document does not specify requirements for ventilators or accessories for anaesthesia applications, which are specified in ISO 80601-2-13 [8]. This document does not specify requirements for home care ventilators or accessories for use with ventilated patients, which are specified in ISO 80601-2-72 [9]. This document does not specify requirements for ventilators or accessories for emergency and transport applications, which are specified in ISO 80601-2-84 [12]. This document does not specify requirements for ventilators or accessories used for home care ventilation support; these are specified in ISO 80601-2-79 [10] and ISO 80601-2-80 [11].