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)

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
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
13-May-2021
Due Date
18-Jul-2021
Completion Date
25-May-2021

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SLOVENSKI STANDARD
SIST EN ISO 19223:2021
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
SIST EN ISO 19223:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19223:2021
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SIST EN ISO 19223:2021
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.
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SIST EN ISO 19223:2021
EN ISO 19223:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 19223:2021
EN ISO 19223:2021 (E)
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.

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SIST EN ISO 19223:2021
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SIST EN ISO 19223:2021
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
---------------------- Page: 7 ----------------------
SIST EN ISO 19223:2021
ISO 19223:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 19223:2021
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 2019 – All rights reserved iii
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SIST EN ISO 19223:2021
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
---------------------- Page: 10 ----------------------
SIST EN ISO 19223:2021
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 ventilator manufacturers

have created new proprietary terms to describe these alternative ways of ventilating patients, and

others have used existing terms with different meanings in different situations. This has led to patient

safety hazards, an example being that lung ventilator clinical orders (settings) for one model of ventilator

can be quite different from those required to get the same result from a different ventilator.

Recognizing these difficulties, ISO Technical Committee ISO/TC 121 requested its Subcommittee, SC 4,

to completely review the terminology and semantics for patient ventilation with a view to compiling a

standardized vocabulary that is applicable to current and, as far as possible, future practice. The primary

objective was to use as much existing terminology as possible, while clarifying its meaning and limiting

its potential for misuse by defining it more precisely. New terms were only introduced where there was

no alternative, either in order to name new concepts or where the misuse of existing vocabulary has

become so widespread that the term has become meaningless or unacceptably ambiguous. Importance

was placed on a vocabulary that would communicate a clear mental model of how the selected settings

would determine the interaction between the patient and the ventilator.

In order to achieve a vocabulary that is coherent, consistent and applicable to a range of fields such as

patient care, research, data collection and incident reporting, this document has been developed with the

participation, cooperation and assistance of members of other standards development organizations,

and of major international ventilator manufacturers. The applications include lung ventilators, medical

data systems facilitating clinical care and research, interoperability, incident reporting and equipment

maintenance.

The early work by the subcommittee in establishing how a standardized vocabulary should be

structured increasingly led to the conclusion that it would be necessary to revert to first principles.

It was recognized that much of the current terminology has its origins in the early use of automatic

ventilation, when the emphasis was inevitably on how best to save the lives of patients who could not

breathe for themselves and, consequently, only made basic provisions for the patient's own respiratory

activity. Since that time, ventilators have become increasingly interactive with the patient, such that it is

now necessary to consider their use from a ventilator-patient system perspective because it is no longer

possible, with any certainty, to predict ahead of time how that interaction will take place.

The terminology in this document is defined and used in a way that makes it capable of facilitating,

unambiguously, both the setting of a ventilator and how to describe and record the resultant ventilator-

patient interactions, continuously and at defined points within the course of ventilation. This includes

the result of the complex interactions that occur when additional breaths are taken during an assured-

inflation cycle, as can occur, for example, during APRV (airway pressure release ventilation).

This document seeks both to provide a consensus view and the basis for a coherent language for

describing ventilator function. Now that the fundamental concepts of artificial ventilation practice

within the scope of this document have matured, it has been possible to review the boundaries between

the various concepts of established ventilation-modes and the methods of artificially inflating a patient's

lungs and to formulate definitions that clarify the common elements and the distinctions. In particular,

the scopes of several concepts that were appropriate to earlier technology and practice have become

inadequate to encompass new developments and it was found necessary to subdivide them. Some of

their designating terms have, therefore, had to be deprecated, replaced or constrained using more

restrictive definitions, resulting in an inevitable reintroduction of some little-used legacy terms and

the need to create a few new terms.
© ISO 2019 – All rights reserved v
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SIST EN ISO 19223:2021
ISO 19223:2019(E)

The overall objective is to encourage a more disciplined use of ventilator vocabulary so that operators

trained in the application of this document will be able to move easily from one ventilator to another

and operate each one, with confidence, after a minimum amount of training. Although it is recognized

that change will not be immediate, it is expected that this discipline will feed through into scientific

publications, textbooks and training so that, over time, a standardized basic language of artificial

ventilation will become internationally established.

Examples of the application of this document are illustrated in the figures of Annexes C and F but these

are not intended to indicate a requirement, nor to impose any restriction on the design of artificial

ventilation devices.

Included with many of the terms are notes to entry that provide supplementary information, including

explanations of the semantics of the term along with their classification schemes. This format is not

only a requirement of ISO 704 but, unlike with such information in an annex, ensures that it remains

associated with the term when viewed on the free-to-access ISO Online Browsing Platform.

Some of the terms in this document are principally intended for technical documents, informatics and

related applications, and might have little applicability to ventilator labelling and instructions for use.

In this document, the following print types are used:
Definitions: roman type.

Material appearing outside of tables, such as notes, examples and references: smaller type.

Terms defined in Clause 3 of this document or as noted, apart from those in the form of acronyms or

initialisms or when used in headings or tables: italic type.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to the usage described in ISO/IEC Directives, Part 2,

Annex H. For the purposes of this document, the auxiliary verb

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this

document,

— “should” means that compliance with a requirement or a test is recommended but is not mandatory

for compliance with this document, and

— “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex A.

Colour coding is employed in most of the figures in Annexes B, C and F of this document to help

distinguish between some of the specific characteristics being illustrated. The coding used for each

figure, or set of figures, is provided either in its own specific key or in the introductory text of each

annex, as applicable.

NOTE The following figures and tables have been reproduced from Reference [34] with permission:

— Figures: B.1, C.1 to C.35 and F.1 to F.7;
— Tables: D.1 to D.3, E.1 and E.2.
vi © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 19223:2021
INTERNATIONAL STANDARD ISO 19223:2019(E)
Lung ventilators and related equipment — Vocabulary and
semantics
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.

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.
2 Normative references
There are no normative references in this document.
3 * Terms, definitions, symbols, and abbreviated terms

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/

NOTE For convenience, an index and a list of sources of all defined terms used in this document are provided

in Annex J.
© ISO 2019 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 19223:2021
ISO 19223:2019(E)
3.1 General artificial-ventilation terminology
3.1.1
ventilator
lung ventilator
DEPRECATED: respirator

medical device or medical electrical equipment intended to provide artificial ventilation

Note 1 to entry: In cases of possible ambiguity the full term, lung ventilator, should be used.

Note 2 to entry: See also ventilation (3.1.9).

[SOURCE: ISO 80601-2-12:2011, 201.3.222, modified — Definition split into two terms (see 3.1.1 and

3.1.10).]
3.1.2
airway

connected, gas-containing cavities and passages within the respiratory system, that conduct gas

between the alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection

port if an airway device is used

Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a

patient. Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.

Note 2 to entry: See also airway device (3.1.3).
3.1.3
airway device

device intended for use as an interface between the patient-connection port of a ventilator and the

patient's airway, and which has no auxiliary features on which the ventilator is dependent for its normal

operation
EXAMPLE Endotracheal tube; tracheotomy tube; face mask; supralaryngeal airway.

Note 1 to entry: The connection to the patient's airway can be at the face (non-invasive) or internal to the patient

(invasive).

Note 2 to entry: A face mask that intentionally vents respiratory gas to atmosphere by means of a bleed orifice

is a functional part of the ventilator breathing system and therefore not an airway device. With that arrangement,

the face seal of the mask becomes the patient-connection port and there is no patient-connection port connector,

nor an airway device.

Note 3 to entry: See also patient-connection port (3.14.5), airway (3.1.2) and ventilator breathing system (3.1.18).

3.1.4
airway resistance

drop in pressure between the patient-connection port and the alveoli per unit rate of airway flow

Note 1 to entry: The airway resistance is normally expressed as a single coefficient, with the implicit assumptions

that it is independent of the flow rate and of the direction of flow. In practice, these assumptions are typically

only approximately valid.
Note 2 to entry: See also airway (3.1.2).
3.1.5
respiratory system compliance
respiratory compliance
DEPRECATED: lung compliance

elastic characteristic of the lung expressed as the change in lung volume per unit change of airway

pressure in the absence of respiratory activity

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by qualification,

to designate this concept as a measured quantity (3.1.20).
2 © ISO 2019 – All rights reserved
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SIST EN ISO 19223:2021
ISO 19223:2019(E)

Note 2 to entry: The respiratory system compliance is normally expressed as a single coefficient, with the implicit

assumptions that it is independent of the volume of gas in the lung and of any hysteresis between increasing and

decreasing volumes. In practice, these assumptions are typically only approximately valid.

Note 3 to entry: Respiratory system compliance is typically determined by a static measurement once the airway

pressure has stabilized during an inspiratory pause. In mechanically ventilated patients it is typically determined

as either a static compliance or a dynamic compliance. There might be differences between the values obtained by

these different methods, not only due to the method itself but also due to viscoelastic effects, pressure balancing

throughout the slower compartments of the lungs and possible recruitment effects.

Note 4 to entry: It is sometimes more applicable to express this characteristic as lung elastance, which is simply

the inverse of respiratory system compliance.

Note 5 to entry: See also lung (3.1.16), airway pressure (3.6.1), respiratory activity (3.2.6), respiratory system

(3.1.17), inspiratory pause (3.4.12), pulmonary compliance (3.1.6), static compliance (3.1.7) and dynamic compliance

(3.1.8).
3.1.6
pulmonary compliance

elastic characteristic of the lungs expressed as the change in the lung volume per unit change of the

difference between the alveolar pressure and the pressure in the pleural space

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by qualification,

to designate this concept as a measured quantity (3.1.20). The specific symbol, C , has been adopted because of

its established usage in the scientific community to represent the ‘compliance of the lungs’.

Note 2 to entry: The pulmonary compliance is the compliance coefficient relating specifically to the lungs, as

distinct from the respiratory system compliance coefficient, which relates to the whole of the respiratory system

and, therefore, includes the compliance of the thoracic cage. For most patients it is not clinically necessary to

differentiate between the compliance of the lungs alone, and th
...

SLOVENSKI STANDARD
oSIST prEN ISO 19223:2021
01-februar-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: prEN ISO 19223
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 19223:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 19223:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 19223:2021
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
---------------------- Page: 3 ----------------------
oSIST prEN ISO 19223:2021
ISO 19223:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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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

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oSIST prEN ISO 19223:2021
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.
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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 ventilator manufacturers

have created new proprietary terms to describe these alternative ways of ventilating patients, and

others have used existing terms with different meanings in different situations. This has led to patient

safety hazards, an example being that lung ventilator clinical orders (settings) for one model of ventilator

can be quite different from those required to get the same result from a different ventilator.

Recognizing these difficulties, ISO Technical Committee ISO/TC 121 requested its Subcommittee, SC 4,

to completely review the terminology and semantics for patient ventilation with a view to compiling a

standardized vocabulary that is applicable to current and, as far as possible, future practice. The primary

objective was to use as much existing terminology as possible, while clarifying its meaning and limiting

its potential for misuse by defining it more precisely. New terms were only introduced where there was

no alternative, either in order to name new concepts or where the misuse of existing vocabulary has

become so widespread that the term has become meaningless or unacceptably ambiguous. Importance

was placed on a vocabulary that would communicate a clear mental model of how the selected settings

would determine the interaction between the patient and the ventilator.

In order to achieve a vocabulary that is coherent, consistent and applicable to a range of fields such as

patient care, research, data collection and incident reporting, this document has been developed with the

participation, cooperation and assistance of members of other standards development organizations,

and of major international ventilator manufacturers. The applications include lung ventilators, medical

data systems facilitating clinical care and research, interoperability, incident reporting and equipment

maintenance.

The early work by the subcommittee in establishing how a standardized vocabulary should be

structured increasingly led to the conclusion that it would be necessary to revert to first principles.

It was recognized that much of the current terminology has its origins in the early use of automatic

ventilation, when the emphasis was inevitably on how best to save the lives of patients who could not

breathe for themselves and, consequently, only made basic provisions for the patient's own respiratory

activity. Since that time, ventilators have become increasingly interactive with the patient, such that it is

now necessary to consider their use from a ventilator-patient system perspective because it is no longer

possible, with any certainty, to predict ahead of time how that interaction will take place.

The terminology in this document is defined and used in a way that makes it capable of facilitating,

unambiguously, both the setting of a ventilator and how to describe and record the resultant ventilator-

patient interactions, continuously and at defined points within the course of ventilation. This includes

the result of the complex interactions that occur when additional breaths are taken during an assured-

inflation cycle, as can occur, for example, during APRV (airway pressure release ventilation).

This document seeks both to provide a consensus view and the basis for a coherent language for

describing ventilator function. Now that the fundamental concepts of artificial ventilation practice

within the scope of this document have matured, it has been possible to review the boundaries between

the various concepts of established ventilation-modes and the methods of artificially inflating a patient's

lungs and to formulate definitions that clarify the common elements and the distinctions. In particular,

the scopes of several concepts that were appropriate to earlier technology and practice have become

inadequate to encompass new developments and it was found necessary to subdivide them. Some of

their designating terms have, therefore, had to be deprecated, replaced or constrained using more

restrictive definitions, resulting in an inevitable reintroduction of some little-used legacy terms and

the need to create a few new terms.
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The overall objective is to encourage a more disciplined use of ventilator vocabulary so that operators

trained in the application of this document will be able to move easily from one ventilator to another

and operate each one, with confidence, after a minimum amount of training. Although it is recognized

that change will not be immediate, it is expected that this discipline will feed through into scientific

publications, textbooks and training so that, over time, a standardized basic language of artificial

ventilation will become internationally established.

Examples of the application of this document are illustrated in the figures of Annexes C and F but these

are not intended to indicate a requirement, nor to impose any restriction on the design of artificial

ventilation devices.

Included with many of the terms are notes to entry that provide supplementary information, including

explanations of the semantics of the term along with their classification schemes. This format is not

only a requirement of ISO 704 but, unlike with such information in an annex, ensures that it remains

associated with the term when viewed on the free-to-access ISO Online Browsing Platform.

Some of the terms in this document are principally intended for technical documents, informatics and

related applications, and might have little applicability to ventilator labelling and instructions for use.

In this document, the following print types are used:
Definitions: roman type.

Material appearing outside of tables, such as notes, examples and references: smaller type.

Terms defined in Clause 3 of this document or as noted, apart from those in the form of acronyms or

initialisms or when used in headings or tables: italic type.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to the usage described in ISO/IEC Directives, Part 2,

Annex H. For the purposes of this document, the auxiliary verb

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this

document,

— “should” means that compliance with a requirement or a test is recommended but is not mandatory

for compliance with this document, and

— “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex A.

Colour coding is employed in most of the figures in Annexes B, C and F of this document to help

distinguish between some of the specific characteristics being illustrated. The coding used for each

figure, or set of figures, is provided either in its own specific key or in the introductory text of each

annex, as applicable.

NOTE The following figures and tables have been reproduced from Reference [34] with permission:

— Figures: B.1, C.1 to C.35 and F.1 to F.7;
— Tables: D.1 to D.3, E.1 and E.2.
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INTERNATIONAL STANDARD ISO 19223:2019(E)
Lung ventilators and related equipment — Vocabulary and
semantics
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.

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.
2 Normative references
There are no normative references in this document.
3 * Terms, definitions, symbols, and abbreviated terms

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/

NOTE For convenience, an index and a list of sources of all defined terms used in this document are provided

in Annex J.
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3.1 General artificial-ventilation terminology
3.1.1
ventilator
lung ventilator
DEPRECATED: respirator

medical device or medical electrical equipment intended to provide artificial ventilation

Note 1 to entry: In cases of possible ambiguity the full term, lung ventilator, should be used.

Note 2 to entry: See also ventilation (3.1.9).

[SOURCE: ISO 80601-2-12:2011, 201.3.222, modified — Definition split into two terms (see 3.1.1 and

3.1.10).]
3.1.2
airway

connected, gas-containing cavities and passages within the respiratory system, that conduct gas

between the alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection

port if an airway device is used

Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a

patient. Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.

Note 2 to entry: See also airway device (3.1.3).
3.1.3
airway device

device intended for use as an interface between the patient-connection port of a ventilator and the

patient's airway, and which has no auxiliary features on which the ventilator is dependent for its normal

operation
EXAMPLE Endotracheal tube; tracheotomy tube; face mask; supralaryngeal airway.

Note 1 to entry: The connection to the patient's airway can be at the face (non-invasive) or internal to the patient

(invasive).

Note 2 to entry: A face mask that intentionally vents respiratory gas to atmosphere by means of a bleed orifice

is a functional part of the ventilator breathing system and therefore not an airway device. With that arrangement,

the face seal of the mask becomes the patient-connection port and there is no patient-connection port connector,

nor an airway device.

Note 3 to entry: See also patient-connection port (3.14.5), airway (3.1.2) and ventilator breathing system (3.1.18).

3.1.4
airway resistance

drop in pressure between the patient-connection port and the alveoli per unit rate of airway flow

Note 1 to entry: The airway resistance is normally expressed as a single coefficient, with the implicit assumptions

that it is independent of the flow rate and of the direction of flow. In practice, these assumptions are typically

only approximately valid.
Note 2 to entry: See also airway (3.1.2).
3.1.5
respiratory system compliance
respiratory compliance
DEPRECATED: lung compliance

elastic characteristic of the lung expressed as the change in lung volume per unit change of airway

pressure in the absence of respiratory activity

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by qualification,

to designate this concept as a measured quantity (3.1.20).
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Note 2 to entry: The respiratory system compliance is normally expressed as a single coefficient, with the implicit

assumptions that it is independent of the volume of gas in the lung and of any hysteresis between increasing and

decreasing volumes. In practice, these assumptions are typically only approximately valid.

Note 3 to entry: Respiratory system compliance is typically determined by a static measurement once the airway

pressure has stabilized during an inspiratory pause. In mechanically ventilated patients it is typically determined

as either a static compliance or a dynamic compliance. There might be differences between the values obtained by

these different methods, not only due to the method itself but also due to viscoelastic effects, pressure balancing

throughout the slower compartments of the lungs and possible recruitment effects.

Note 4 to entry: It is sometimes more applicable to express this characteristic as lung elastance, which is simply

the inverse of respiratory system compliance.

Note 5 to entry: See also lung (3.1.16), airway pressure (3.6.1), respiratory activity (3.2.6), respiratory system

(3.1.17), inspiratory pause (3.4.12), pulmonary compliance (3.1.6), static compliance (3.1.7) and dynamic compliance

(3.1.8).
3.1.6
pulmonary compliance

elastic characteristic of the lungs expressed as the change in the lung volume per unit change of the

difference between the alveolar pressure and the pressure in the pleural space

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by qualification,

to designate this concept as a measured quantity (3.1.20). The specific symbol, C , has been adopted because of

its established usage in the scientific community to represent the ‘compliance of the lungs’.

Note 2 to entry: The pulmonary compliance is the compliance coefficient relating specifically to the lungs, as

distinct from the respiratory system compliance coefficient, which relates to the whole of the respiratory system

and, therefore, includes the compliance of the thoracic cage. For most patients it is not clinically necessary to

differentiate between the compliance of the lungs alone, and the compliance of the respiratory system, so the more

directly measurable respiratory system compliance provides sufficient information. If an impaired respiratory

system is indicated, the difference might be significant and can justify the more invasive and skilled procedure

required to obtain a measurement of pressure in the pleural space (the intrapleural pressure) and, thereby, that

of the pulmonary compliance.

Note 3 to entry: The difference between the alveolar pressure and the pleural pressure is typically referred to as

the transpulmonary pressure.

Note 4 to entry: The pulmonary compliance is normally expressed as a single coefficient, with the implicit

assumptions that it is independent of the volume of gas in the lungs, of any hysteresis between increasing and

decreasing volumes and of any variation of the pleural pressure within the pleural space. In practice, these

assumptions are typically only approximately valid.

Note 5 to entry: See also lung (3.1.16), airway pressure (3.6.1), respiratory system (3.1.17) and respiratory system

compliance (3.1.5).
3.1.7
static compliance

respiratory system compliance determined, under quasi-static conditions and while connected to a

ventilator, as the measured change in inspiratory volume per unit change in the measured plateau

inspiratory pressure relative to the measured total PEEP

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by

stat
qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: For the purposes of this measurement, quasi-static conditions are considered to occur during a

respiratory phase of low airway flow and no significant respiratory activity.

Note 3 to entry: Expressed as an equation: static compliance = inspiratory volume / (plateau pressure – total PEEP).

If the presence of auto-PEEP is not suspected or a value for total PEEP is not readily available, the set BAP may be

used as a substitute for total PEEP in this equation.

Note 4 to entry: See also respiratory system compliance (3.1.5), inspiratory volume (3.8.3), plateau inspiratory

pressure (3.6.4), total PEEP (3.10.6), auto-PEEP (3.10.7) and BAP (3.10.2).
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3.1.8
dynamic compliance
respiratory system compliance determined during normal mechanical ventilation

Note 1 to entry: In addition to its direct reference, this term or its symbol, C , is used, in context or by

dyn
qualification, to designate this concept as a measured quantity (3.1.20).

Note 2 to entry: Dynamic compliance is a dynamically calculated value obtained during normal mechanical

ventilation by measuring the rate of change of inspiratory volume per unit change of airway pressure. A least

squares or other curve-fitting algorithm can be used, typically in conjunction with the equation of motion for

the respiratory system, to correct for any transient dynamic effects. When this term is used, the basis of the

calculation employed should be made available to the user.
3.1.9
ventilation
cyclical movement of a respirable gas into and out of the lungs

Note 1 to entry: This might be by external or spontaneous means, or by a combination of both.

Note 2 to entry: See also spontaneous breath (3.2.3), artificial ventilation (3.1.10), automatic ventilation (3.1.12),

mechanical ventilation (3.1.11), negative-pressure ventilation (3.1.14), positive-pressure ventilation (3.1.13) and

inflation (3.3.1).
3.1.10
artificial ventilation

intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external

means with the intention of augmenting, or totally controlling, the ventilation of a patient

EXAMPLE Means used to provide artificial ventilati
...

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