This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES:

— intended for use in the HOME HEALTHCARE ENVIRONMENT;
— intended for use by a LAY OPERATOR; and
— 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).

NOTE 1 In the HOME HEALTHCARE ENVIRONMENT, the SUPPLY MAINS is often not reliable.

NOTE 2 Such VENTILATORY SUPPORT EQUIPMENT can also be used in non-critical care applications of professional health care facilities.

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, 7.2.13 and 8.4.1.

NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

Cross References:
ISO 80601-2-12
ISO 5367:2014
ISO 17510:2015
ISO 80369-7:2016
ISO 16142-1:2016
ISO 15223-1:2016
ISO 8836:2014
ISO 4871:1996
ISO 7396-1:2016
ISO 80601-2-74:2017
ISO 18562-1:2017
IEC 60601-1:2005
ISO 9360-2:2001
ISO 9360-1:2000
IEC 61672-1:2013
IEC 60601-1-11:2015
EN 15986:2011
IEC 60601-1-2:2014
ISO 23328-1:2003
ISO 23328-2:2002
IEC 60601-1-6:2010
ISO 80369-1:2010
IEC 60601-1:2005/AMD1:2012
ISO 17664:2017
ISO 4135:2001
ISO 80601-2-72:2015
ISO 9000:2015
IEC 62366-1:2015
ISO 3744:2010
IEC 60601-1-8:2006
ISO 5356-1:2015
BS ISO 80601-2-80:2018
IEC TR 60878:2015
ISO 80601-2-80:2018
ISO 10651-6:2004
ISO 80601-2-13:2011
ISO 14159
ISO 10651-3
ISO 80601-2-84
TR 21954
ISO 10524-1
IEC 60601-1-3
IEC 80601-2-70:2015
ISO 639-1
ISO 80369-2
ISO 7000:2014


Incorporates the following:
Corrigendum, September 2019