DIN EN ISO 80601-2-12
; 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
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
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.
Document: references other documents
Responsible national committee
DKE/UK 804.7 - Inhalationsnarkose- und Beatmungsgeräte
Responsible european committee
CEN/TC 215/WG 2 - Lung ventilators and related equipment
Responsible international committee
ISO/TC 121/SC 3/JWG 1 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators
