Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

ISO 80601-2-70:2025 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.

Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.

This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.

This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.

This document is also applicable to those accessories intended by their m