Skip to main content
Back

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
None

Standard history

Status
Date
Type
Name
01.12.2023
Main
02.04.2020
Main

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.

ISO 80601-2-12 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.

Required fields are indicated with *

*
*
*
PDF
46.36 € incl tax
PDF redline
60.27 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN ISO 80601-2-55:2018+A1:2023

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018 + ISO 80601-2-55:2018/Amd 1:2023)
Newest version Valid from 29.12.2023
Main

EVS-ISO 10005:2019

Quality management - Guidelines for quality plans (ISO 10005:2018, identical)
Newest version Valid from 16.09.2019
Main

EVS-EN ISO 80601-2-84:2023

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
Newest version Valid from 01.12.2023
Main

EVS-EN ISO 80601-2-74:2021

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
Newest version Valid from 03.08.2021