SIST EN ISO 19223:2021

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

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.

Beatmungsgeräte und zugehörige Geräte - Terminologie und Semantik (ISO 19223:2019)

Dieses Dokument legt ein Vokabular der Begriffe und Semantiken für alle Bereiche der Beatmungsversorgung fest einschließlich mechanischer Beatmung, wie etwa Intensiv-Beatmung, Anästhesie-Beatmung, Rettungs- und Transport-Beatmung und Heim-Beatmung, einschließlich Schlaf-Apnoe-Atemtherapie-Geräte. Es gilt für:
- Normen für Beatmungsgeräte und Atem-Therapiegeräte,
- Normen zu medizinischer Informatik,
- die Beschriftung medizinischer elektrischer Geräte und medizinischer elektrischer Systeme,
- Gebrauchsanweisungen und Begleitdokumente für medizinische elektrische Geräte und medizinische elektrische Systeme,
- die Interoperabilität von medizinischen elektrischen Geräten und medizinischen elektrischen Systemen, und
- elektronische Gesundheitsakten.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an ein Atemsystem des Beatmungsgeräts oder ein Beatmungsgerät vorsieht, bei dem die Merkmale dieses Zubehörs die Sicherheit oder wesentlichen Leistungsmerkmale des Beatmungsgeräts und des Atemsystems des Beatmungsgeräts beeinflussen können.
ANMERKUNG Dieses Dokument kann darüber hinaus für andere Anwendungen in Verbindung mit der Lungen-Beatmung einschließlich nichtelektrischer Geräte und Einrichtungen, der Forschung, der Beschreibung kritischer Ereignisse, der forensischen Analyse und in Meldesystemen für unerwünschte Ereignisse (Überwachung) verwendet werden.
Dieses Dokument legt keine spezifischen Begriffe für Atem-Therapiegeräte, oder die physiologisch geschlossenen Regelkreise der Beatmung, die Hochfrequenz-Beatmung oder die Unterdruckbeatmung oder für den extrakorporalen Gasaustausch oder Sauerstoffaustausch fest, außer wo dies als erforderlich angesehen wird, um Grenzen zwischen benachbarten Konzepten festzulegen.

Ventilateurs pulmonaires et équipement associé - Vocabulaire et sémantique (ISO 19223:2019)

Le présent document établit un vocabulaire de termes et de sémantique pour tous les domaines des soins respiratoires impliquant une ventilation mécanique, tels que la ventilation en soins intensifs, la ventilation en anesthésie, la ventilation d'urgence et de transport et la ventilation à domicile, y compris le matériel de traitement respiratoire de l'apnée du sommeil. Il est applicable:
—          dans les normes relatives aux ventilateurs pulmonaires et aux dispositifs de thérapie respiratoire;
—          dans les normes relatives à l'informatique de santé;
—          pour l'étiquetage d'équipements et de systèmes électromédicaux;
—          dans les instructions d'utilisation et documents d'accompagnement relatifs aux équipements et systèmes électromédicaux;
—          pour l'interopérabilité d'équipements et de systèmes électromédicaux; et
—          dans les dossiers médicaux informatisés.
Le présent document est également applicable aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire d'un ventilateur ou à un ventilateur, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du ventilateur et du système respiratoire du ventilateur.
NOTE       Le présent document peut également être utilisé pour d'autres applications en rapport avec la ventilation pulmonaire, notamment les dispositifs et équipements non électriques, la recherche, la description d'événements critiques, l'analyse médico-légale et les systèmes de notification (veille) des effets indésirables.
Le présent document ne spécifie pas de termes spécifiques aux équipements de thérapie respiratoire, à la ventilation physiologique en boucle fermée, à la ventilation à haute fréquence ou à la ventilation à pression négative; ni à l'aide respiratoire par ventilation liquide, par échange gazeux extracorporel ou par oxygène, excepté lorsqu'il a été jugé nécessaire d'établir des limites entre des concepts voisins.

Pljučni ventilatorji in pripadajoča oprema - Slovar in semantika (ISO 19223:2019)

General Information

• Status: Published
• Public Enquiry End Date: 19-Jan-2021
• Publication Date: 24-May-2021
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-May-2021
• Due Date: 18-Jul-2021
• Completion Date: 25-May-2021
• Ref Project: EN ISO 19223:2021 - Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Pljučni ventilatorji in pripadajoča oprema - Slovar in semantika (ISO 19223:2019)
Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)
Beatmungsgeräte und zugehörige Geräte - Terminologie und Semantik (ISO
19223:2019)
Ventilateurs pulmonaires et équipement associé - Vocabulaire et sémantique (ISO
19223:2019)
Ta slovenski standard je istoveten z: EN ISO 19223:2021
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19223
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 01.040.11; 11.040.10
English Version
Lung ventilators and related equipment - Vocabulary and
semantics (ISO 19223:2019)
Ventilateurs pulmonaires et équipement associé - Beatmungsgeräte und zugehörige Geräte -
Vocabulaire et sémantique (ISO 19223:2019) Terminologie und Semantik (ISO 19223:2019)
This European Standard was approved by CEN on 12 April 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19223:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 19223:2019 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 19223:2021 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2021, and conflicting national standards shall
be withdrawn at the latest by April 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 19223:2019 has been approved by CEN as EN ISO 19223:2021 without any modification.

INTERNATIONAL ISO
STANDARD 19223
First edition
2019-07
Lung ventilators and related
equipment — Vocabulary and
semantics
Ventilateurs pulmonaires et équipement associé — Vocabulaire et
sémantique
Reference number
ISO 19223:2019(E)
©
ISO 2019
ISO 19223:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Fax: [phone]
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Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 19223:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 * Terms, definitions, symbols, and abbreviated terms . 1
3.1 General artificial-ventilation terminology . 2
3.2 Breath terminology . 9
3.3 Lung inflation terminology .13
3.4 * Time, phase and cycle terminology .18
3.5 * Rate terminology .23
3.5.1 Preferred rate concepts.23
3.5.2 Secondary rate concepts — Rate terms for use if required for specific purposes 25
3.6 Pressure terminology .26
3.7 Flow terminology .30
3.8 Volume terminology .34
3.9 Initiation and termination terminology .38
3.10 * Baseline and PEEP terminology .43
3.11 * Mode terminology .48
3.12 * Bi-level terminology .60
3.13 Safety limits and alarm terminology .64
3.14 Gas port terminology .67
Annex A (informative) Rationales and guidance.69
Annex B (informative) Conceptual relationships between ventilator actions and types of breath .75
Annex C (informative) Illustrations of ventilation terms .77
Annex D (informative) Classification of inflation-types .109
Annex E (informative) Classification of ventilation-modes .114
Annex F (informative) Concepts relating to baseline airway pressures and PEEP as used in
this document .116
Annex G (informative) Conventions followed in this document .125
Annex H (informative) Implementation guidance for the vocabulary of this document .127
Annex I (informative) Equivalence declaration tables.129
Annex J (informative) Terminology — Alphabetized index of defined terms .132
Bibliography .139
ISO 19223:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 4, Vocabulary and semantics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

ISO 19223:2019(E)
Introduction
The characteristics of ventilation-modes of current automatic lung ventilators are often not well
understood. The current terminology used for their description is based on that introduced in the early
days of mechanical ventilation, but with the advances in ventilators, and ventilation-modes that have
evolved over recent years, the language used has been continuously adapted. In the absence of any
effective international coordinating action, this has inevitably led to increasing inconsistencies in the
way in which well-established terms and their derivatives are used.
To further compound the difficulties in understanding these complexities, some
...