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Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023); German version EN ISO 80601-2-12:2023

Standard [CURRENT]

DIN EN ISO 80601-2-12:2025-03

VDE 0750-2-12:2025-03

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023); German version EN ISO 80601-2-12:2023

German title
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2023); Deutsche Fassung EN ISO 80601-2-12:2023
Publication date
2025-03
Original language
German
Pages
167

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Publication date
2025-03
Original language
German
Pages
167
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Overview

This document applies to the basic safety and the essential performance characteristics of ventilators for intensive care together with their accessories, the combination of which is hereinafter referred to as ME device. Hazards arising from the intended physiological mode of operation of ME devices or ME systems within the scope of this document are not covered by specific requirements in this document. This document does not apply to a ME device or ME system operating in a ventilator mode intended exclusively for patients who are not dependent on artificial ventilation. This document does not apply to ME devices intended exclusively for use in a professional healthcare facility to augment the ventilation of spontaneously breathing patients.

Replacement amendments

This document replaces DIN EN ISO 80601-2-12 Berichtigung 1:2021-02; VDE 0750-2-12 Berichtigung 1:2021-02 , DIN EN ISO 80601-2-12:2020-07; VDE 0750-2-12:2020-07 .

This document has been corrected by: DIN EN ISO 80601-2-12 Berichtigung 1:2025-11; VDE 0750-2-12 Berichtigung 1:2025-11 .

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