CSA C22.2 No. 80601-2-70:23
Scope
IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:
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 mechanical ventilation.
This document 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 document 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. 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 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 document are not covered by specific requirements in this document except in 7.2.13 and
8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory
ventilators (HFOVs), which are given in ISO 80601-2-87[13].
This document does not specify the requirements for ventilators or accessories intended for critical care
ventilators for ventilator-dependent patients, which are given in ISO 80601-2-12.
This document does not specify the requirements for ventilators or accessories intended for anaesthetic
applications, which are given in ISO 80601-2-13[8].
This document does not specify the requirements for ventilators or accessories intended for home care
ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9].
This document does not specify the requirements for ventilators or accessories intended for emergency
and transport, which are given in ISO 80601-2-84[12].
This document does not specify the requirements for ventilators or accessories intended for home-care
ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601-2-80[11].
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.040.10
Statut:
Norme
Date de Publication:
2023-02-28
Numéro Standard:
CSA C22.2 No. 80601-2-70:23