ISO 80601-2-12:2023
Issue date: 2023 11 03
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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:
¾ 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