Please select and order
€192.95
excl. VAT
Add to cart
Norm

ISO 80601-2-12:2023

Issue date: 2023 11 03

Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipme...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 158 Pages
Language:
English

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:

¾     intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.

NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an

ISO 80601-2-12:2023
2023 11 03
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential per...
Norm
ISO 80601-2-12:2020
2020 02 25
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential per...
Norm
ISO 80601-2-12:2011/Cor 1:2011
2011 10 11
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential per...
Norm
ISO 80601-2-12:2011
2011 04 07
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential per...
Norm
ISO 10651-1:1993
1993 06 03
Lung ventilators for medical use — Part 1: Requirements
Norm
ISO 5369:1987
1987 06 25
Breathing machines for medical use — Lung ventilators
Norm
Expand