UNE-EN ISO 80601-2-70:2025

201.1 Scope, object and related standardsNOTE There is guidance or rationale for this subclause contained in Clause AA.2IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.1 ScopeNOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapyequipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who sufferfrom obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of thepatient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment bylay operators as well as in professional healthcare institutions.Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control systemunless 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 artificial ventilation. This document is not applicable to ME equipment or an ME system intendedfor 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 manufacturer to be connected to sleepapnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safetyor essential performance of the sleep apnoea breathing therapy equipment.Masks and application accessories intended for use during sleep apnoea breathing therapy are additionallyaddressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.If a clause or subclause is specifically intended to be applicable to ME equipment 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 appliesboth to ME equipment and to ME systems, as relevant.Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of thisdocument are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the generalstandard.NOTE 2 See also 4.2 of the general standard.