NEN-EN-ISO 80601-2-12:2020 en

Current standard
|
138 Pages
|
Publication date 2020-03-01
|
English
Log in
Create a free account
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
NEN-EN-ISO 80601-2-12 applies to the basic safety and essential performance of a ventilator in combinationwith its accessories, hereafter referred to as ME equipment:- intended for use in an environment that provides specialized care for patients whoseconditions can be life-threatening and who can require comprehensive care and constantmonitoring in a professional healthcare facility;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 ventilationincluding for ventilator-dependent patients.A critical care ventilator is not considered to utilize a physiologic closed-loop-control systemunless 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 beconnected to a ventilator breathing system, or to a ventilator, where the characteristics of thoseaccessories can affect the basic safety or essential performance of the ventilator.

Number of users reached

Number of simultaneous users for this license reached. Try again later or contact your company administrator to ask for access to this license.
Close