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
ventilatory support equipment, as defined in 201.3.302, for
ventilatory impairment, as defined in 201.3.300, hereafter also referred to as
ME equipment, in combination with its
accessories:
— intended for use in the
home healthcare environment;
NOTE 2: In the
home healthcare environment, the
supply mains driving the
ventilatory support equipment is often not reliable.
NOTE 3: Such
ventilatory support equipment can also be used in professional health care facilities.
— intended for use by a
lay operator;
— intended for use with
patients who have
ventilatory impairment, the most fragile of these
patients, would not likely experience injury with the loss of this
artificial ventilation; and
— not intended for
patients who are dependent on
artificial ventilation for their immediate life support.
EXAMPLE 1:
Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment 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
breathing system of
ventilatory support equipment for
ventilatory impairment, where the characteristics of those
accessories can affect the
basic safety or
essential performance of the
ventilatory support equipment for
ventilatory impairment.
EXAMPLE 2: Breathing sets,
connectors, water traps, expiratory valve,
humidifier, breathing system filter, external electrical power source,
distributed alarm system.
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.
NOTE 5: See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given
patient.
| File Size : | 1
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| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 09/01/2024 |
