Lung ventilators and related equipment Vocabulary and semantics
Document Title [Hindi] :
फेफड़े के वेंटिलेटर और संबंधित उपकरण - शब्दावली और शब्दार्थ
Document Type :
New
Language :
English
Priority :
3
ICS Code :
01.040.11,11.040.10
Date of Project Approval :
24-04-2024
Standards to be Superseded :
Classification Details
Group :
Medical and Hospital Equipments
Sub Group :
Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group :
Diagnostic , anaesthetic and respiratory equipment
Aspects :
Code of Practice
Risk :
Low
Certification :
Voluntary Certification
Short Commom Man's Title :
Vocabulary and semantics
ITCHS Code :
Ministry :
Ministry of Health and Family Welfare
Sustainable development Goals :
GOOD HEALTH AND WELL BEING
Degree of Equivalence :
Identical under dual numbering
Identical/Equivalent Standards :
ISO 19223:2019
Organization Type:
ISO
Division Council Chairperson Approval Details
Sl.No.
Synosis Points
1
SCOPE
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.
2
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 nonelectrical
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 closedloop
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.