This document applies to the basic safety and essential performance of a 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 1 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 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.

— 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 utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator

. NOTE 4 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.

Cross References:
ISO 9000:2015
IEC 61672-1:2013
ISO 3744:2010
ISO 9360-1:2000
ISO 4871:1996
ISO 15223-1:2016
ISO 7010:2019
ISO 8836:2014
ISO 80369-1:2018
ISO 17510:2015
ISO 9360-2:2001
IEC 60601-1-8:2006/AMD1:2012
ISO 16142-1:2016
ISO 23328-1:2003
ISO 80601-2-55:2018
ISO 19223:2019
ISO 5359:2014
ISO 7396-1:2016
ISO 5367:2014
ISO 18562-1:2017
ISO 5356-1:2015
ISO 14937:2009
IEC 60601-1-6:2010/AMD1:2013
ISO 17664:2017
IEC 62304:2006/AMD1:2015
ISO 23328-2:2002
IEC 60601-1-2:2014


All current amendments available at time of purchase are included with the purchase of this document.