IEC 60601‑1:2005+AMD1:2012+AMD2:2020
, Clause 1
applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and
essential performance of an EMS
ventilator in combination with its
accessories, hereafter also referred to as
ME equipment:
-
— intended for patients who need differing levels
of support from artificial
ventilation including
ventilator-dependent
patients;
-
— intended to be operated by a healthcare professional
operator;
-
— intended for use in the EMS
environment; and
-
— intended for invasive or non-invasive ventilation.
NOTE 2 An EMS
ventilator can also be used for
transport within a professional healthcare
facility.
An EMS
ventilator is not considered to use a
physiologic closed loop-control system unless it
uses a physiological patient variable to adjust the
artificial
ventilation therapy settings.
This document is also applicable to those accessories
intended by their manufacturer to be connected to the
ventilator breathing
system, or to an EMS
ventilator, where the characteristics
of those accessories can affect the basic
safety or essential performance of the
EMS
ventilator.
NOTE 3 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 IEC 60601‑1:2005+AMD1:2012+AMD2:2020,
7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020,
4.2.
This document does not specify the requirements for the following:
NOTE 5 See ISO/TR 21954 for
guidance on the selection of the appropriate
ventilator for a given
patient.
-
—
ventilators or accessories
intended for ventilator-dependent patients
in critical care applications, which are given in ISO 80601‑2‑12.
-
—
ventilators or accessories
intended for ventilator-dependent patients
in the home healthcare
environment, which are given in
ISO 80601‑2‑72.
-
—
ventilators or accessories
intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
-
—
ventilators or accessories
intended for ventilatory support equipment (intended only to
augment the ventilation of spontaneously
breathing patients), which are given in ISO 80601‑2‑79
and ISO 80601‑2‑80.
-
— obstructive sleep apnoea therapy ME equipment,
which are given in ISO 80601‑2‑70.
-
— user-powered resuscitators, which are given in ISO 10651‑4.
-
— gas-powered emergency resuscitators, which are given in ISO 10651‑5.
-
—
continuous positive airway
pressure
(CPAP) ME
equipment.
-
— high-frequency jet ventilators (HFJVs), which
are given in ISO 80601‑2‑87.
-
— high-frequency oscillatory ventilators
(HFOVs)[44], which are given in ISO 80601‑2‑87.
NOTE 6 An EMS
ventilator can
incorporate high-frequency jet or high-frequency
oscillatory ventilation-modes.
-
— respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90.
NOTE 7 An EMS
ventilator can
incorporate high-flow therapy operational mode, but such
a mode is only for spontaneously breathing
patients.
-
— oxygen therapy constant flow ME equipment.
-
— cuirass or “iron-lung”
ventilators.