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RS ISO 80601-2-12: 2023
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Abstract

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-operable ventilator).
NOTE 4 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 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 ventilator breathing system, or to a ventilator, where the c

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 80601-2-12: 2023	ADOPTED ISO STANDARDS	Electrical engineering	169	Third Edition Dec 2025	Available