Appareils électromédicaux — Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du sommeil

This particular standard 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.

This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with neonates.

This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are not dependent on mechanical ventilation.

This particular standard is not applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are dependent on mechanical ventilation such as PATIENTS with central sleep apnoea.

This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.

MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. 3) Refer to Figure AA.1 for items covered further under this standard.

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 applies both 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 this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.