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

Current standard
138 Pages
Publication date 2020-03-01
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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.

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