Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions
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, t...
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions