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 is applicable to the basic safety and essential performance of sleep apnoea breathingtherapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms ofpatients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to therespiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in thehome 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-controlsystem 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 notdependent on mechanical ventilation.This document is not applicable to ME equipment or an ME system intended for those patients who aredependent on mechanical ventilation such as patients with central sleep apnoea.This document is also applicable to those accessories intended by their manufacturer to be connected tosleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect thebasic safety or essential performance of the sleep apnoea breathing therapy equipment.Masks and application accessories intended for use during sleep apnoea breathing therapy areadditionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under thisdocument.If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systemsonly, the title and content of that clause or subclause will say so. If that is not the case, the clause orsubclause applies both to ME equipment and to ME systems, as relevant.