Abstract

This document applies to the basic safety and the essential performance characteristics of ventilators together with their accessories, the combination of which is hereinafter referred to as ME device and which are intended for the following: - for those patients who may be dependent on artificial ventilation; - For use in an environment that provides special care for patients whose condition may be life-threatening and who may require extensive care and continuous monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, this includes patient transportation within a professional healthcare facility (i.e. a ventilator that is operable while moving). NOTE 2 An intensive care ventilator intended for transportation within a professional healthcare facility is not considered an emergency or ambulance ventilator. - for operation by a medically trained operator. NOTE 3 Such ventilators are considered to be life support. NOTE 4 For the purposes of this document, such an environment is referred to as an intensive care environment.

Begin

2021-06-09

WI

00215323

Planned document number

DIN EN ISO 80601-2-12

Project number

02230158

Responsible national committee

DKE/UK 812.3 - Inhalationsnarkose- und Beatmungsgeräte  

Responsible european committee

CEN/TC 215/WG 2 - Lung ventilators  

Responsible international committee

ISO/TC 121/SC 3/JWG 1 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators  

draft standard

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/DIS 80601-2-12:2021); German and English version prEN ISO 80601-2-12:2021
2021-11
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previous edition(s)

Medical electrical Equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020); German version EN ISO 80601-2-12:2020; Corrigendum 1
2021-02

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Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020); German version EN ISO 80601-2-12:2020
2020-07

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