EVS-EN ISO 80601-2-12:2023

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

General information
Valid from 01.12.2023
Base Documents
ISO 80601-2-12:2023; EN ISO 80601-2-12:2023
Directives or regulations

Standard history

ISO 80601-2-12 applies to the basic safety and essential performance of a critical care ventilator, combined with its accessories, hereafter referred to as ME equipment. These ventilators are:

— Intended for use in a critical care environment, where specialized care is provided for patients with life-threatening conditions, requiring comprehensive care and constant monitoring in a professional healthcare facility.

— Considered life-sustaining devices for this document.

— Can provide ventilation during transport within a professional healthcare facility, making them transit-operable ventilators.

— Not considered emergency medical services environment ventilators when intended for transport within a professional healthcare facility.

Additionally, these critical care ventilators are:

— Intended to be operated by a healthcare professional operator.

— Designed for patients who require varying levels of support from artificial ventilation, including ventilator-dependent patients.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

The text of ISO 80601-2-12:2023 has been approved in Europe as EN ISO 80601-2-12:2023 without any changes.
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