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 a critical care
ventilator
in combination with its accessories, hereafter referred
to as ME equipment:
-
— intended for use in an environment that provides specialized care
for patients whose conditions can be
life-threatening and who can require comprehensive care and
constant monitoring in a professional healthcare
facility;
NOTE 2 For the purposes of this document, such an environment is
referred to as a critical care environment.
Ventilators for this
environment are considered life-sustaining.
NOTE 3 For the purposes of this document, such a critical care
ventilator can provide
ventilation during transport within a professional healthcare
facility (i.e. be a
transit-operableventilator).
NOTE 4 A critical care ventilator intended for
use in transport within a professional healthcare
facility is not considered as
an emergency medical
services environmentventilator.
-
— intended to be operated by a healthcare professional
operator; and
-
— intended for those patients who need differing
levels of support from artificial ventilation
including for ventilator-dependent patients.
A critical care 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 a
ventilatorbreathing system, or to a
ventilator, where the characteristics of those
accessories can affect the basic
safety or essential performance of the
ventilator.
NOTE 5 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 6 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020,
4.2.
This document is not applicable to ME equipment or an
ME system operating in a ventilator-operational mode solely
intended for patients who are not dependent on
artificial
ventilation.
NOTE 7 A critical care ventilator, when operating in such a
ventilator-operational mode, is not
considered life-sustaining.
This document is not applicable to ME equipment that is
intended solely to augment the ventilation of spontaneously breathing
patients within a professional
healthcare facility.
This document does not specify the requirements for:
NOTE 8 See ISO/TR 21954 for
guidance on the selection of the appropriate ventilator for a given
patient.
-
—
ventilators
or
accessories intended for anaesthetic
applications, which are given in ISO 80601‑2‑13;
-
—
ventilators
or
accessories intended for the
emergency medical services
environment, which are given in
ISO 80601‑2‑84;
-
—
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 home-care
ventilatory support devices, 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;
-
—
continuous positive airway
pressure
(CPAP) ME
equipment.
-
— high-frequency ventilators, which are given in
ISO 80601‑2‑87;
NOTE 9 A critical care ventilator can incorporate
high-frequency jet or high-frequency oscillatory
ventilator-operational
modes.
-
— respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90;
NOTE 10 A critical care ventilator can incorporate
high-flow therapy operational mode, but such a mode is only
for spontaneously breathing patients.
-
— oxygen therapy constant flow ME equipment;
and
-
— cuirass or “iron-lung”
ventilation equipment.