Back

EVS-EN ISO 19223:2021

Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)

General information
Valid from 03.05.2021
Base Documents
ISO 19223:2019; EN ISO 19223:2021
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.05.2021
Main
This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying documents,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
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 and ventilator breathing system.
NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.
*
*
*
PDF
34.16 € incl tax
Paper
34.16 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN 60601-1-10:2008+A1+A2:2021

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + IEC 60601-1-10:2007/A1:2013 + IEC 60601-1-10:2007/A2:2020)
Newest version Valid from 17.08.2021
Main

EVS-EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Newest version Valid from 16.09.2021
Main + amendment

EVS-EN 62133-2:2017+A1:2021

Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems (IEC 62133-2:2017 + IEC 62133-2:2017/AMD1:2021)
Newest version Valid from 01.10.2021
Main

EVS-EN ISO 10535:2021

Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)
Newest version Valid from 15.11.2021