Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020) (Endorsed by Asociación Española de Normalización in January of 2021.)

2Scope / Description

Basic safety and essential performance requirements for sleep apnoea therapy devices intended to provide relief to patients suffering from obstructive sleep apnoea by delivering therapeutic pressure to the patient's airway. The devices may be used in a home healthcare environment or in a professional healthcare setting and may be operated by non-professionals. * Sleep apnoea therapy devices are not considered to utilize a physiological closed-loop control system unless physiological variables are used to adjust the therapy settings. This document does not apply to sleep apnoea therapy devices for neonates. This document applies to me equipment or me systems intended for use with patients not dependent on mechanical ventilation. This document does not apply to me equipment or me systems intended for use with patients dependent on mechanical ventilation (e.g. patients with central sleep apnoea). This document also applies to accessories designed by the manufacturer to be connected to sleep apnoea therapy devices, the characteristics of which may affect the basic safety or essential performance of the sleep apnoea therapy devices. Masks and applied accessories are dealt with separately in ISO 17510, see Annex AA.1 for other items covered by this document. If a clause or sub-clause applies specifically to me equipment or only to me systems, this will be noted in the title and content of the clause or sub-clause. If no such statement is made, the clause or subclause applies to both ME EQUIPMENT and ME SYSTEMS (as appropriate).