ANALYSIS

© Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.

Classifying Ventilation Modes and

Improving Operator Training with
ISO 19223:2019
Debra R. Milamed and Norman S. Jones

The Centers for Disease Control and Preven- At that time, ISO 4135:20015 was the only
Debra R. Milamed, MS, is tion has reported that more than 300,000 international standard that included terms
associate in anaesthesia at Harvard patients are ventilated in the United States related to devices of that type; however, its
Medical School in Boston, MA, and each year.1,2 Human factors and communica- scope was restricted to defining terms that
committee manager of ISO/TC 121/ tion issues have been cited as the two most were used in standards related to the
SC 4. Email: debra_milamed@hms. common causes of ventilator-related sentinel performance of such equipment and
harvard.edu events, according to reports of patient therefore did not cover usage factors. The
Corresponding author mortality or severe harm received by The terms in general clinical use had origins in
Joint Commission during 2004–15.2,3 the early days of mechanical ventilation,
Norman S. Jones, PhD, is an Over a decade ago, it was determined that when the emphasis was on saving the lives
independent medical engineering the scope of the International Electrotechni- of patients who were unable to breathe on
consultant in Stanbridge, cal Commission (IEC) standard IEC their own, with little attention given to
Bedfordshire, UK, and project leader 60601-1:20054 had to be extended to consider patients' respiratory activity.
for ISO 19223, ISO/TC 121/SC 4. equipment usability in its third edition. The
Joint Working Group (JWG) of the Interna- Approach to the Challenge
tional Organization for Standardization Although ventilators were being continu-
(ISO) and IEC subcommittees responsible ously improved and becoming progressively
for critical care ventilators (ISO/TC 121/SC 3 more patient interactive, the associated
and IEC TC/SC 62D/JWG 1) concurred that terminology had only become increasingly
there was a wide recognition that a key factor confusing. Proprietary terms describing
adversely affecting lung ventilator usability alternative means of ventilating patients
was the lack of a standardized vocabulary had been introduced by some manufactur-
relating to the modes of operation for these ers, and existing terms were used
devices. inconsistently. One effect was that clinical
orders comprising ventilator settings for
one model of ventilator could produce a
Key Takeaways very different result when applied to
• Confusing, inconsistent terminology associated with different manu- another.
facturers' ventilators has adversely affected lung ventilator usability, Chatburn and colleagues drew attention
challenged healthcare facilities in training clinicians adequately, and to the challenges faced by clinicians,
made it difficult for manufacturers to compare the detailed operation educators, and others resulting from the
of their products with competitors’ devices. lack of a coherent vocabulary, including
• A new International Organization for Standardization (ISO) standard, difficulty in comparing published studies or
ISO 19223:2019 (Lung Ventilators and related equipment—Vocabulary reports of clinical trials and a lack of
and semantics), defines and describes the use of ventilator terminology consistency among education programs.6,7
in a manner that will facilitate the setting of a ventilator and the When different manufacturers supplied
description and recording of ventilator-patient interactions, without ventilators to the same institution, training
ambiguity, both continuously and at specific points during ventilation. resources often were inadequate for all
• A key feature of ISO 19223 is the introduction of ventilation-mode modes of all ventilator brands. From the
groups, which are “groups of ventilation-modes that share fundamen- point of view of manufacturers, it was
tal features with respect to the characteristics of their ventilation-pat- increasingly difficult to compare the
terns.” This system provides a useful primary classification means for detailed operation of their products with
the large number of mode names used by manufacturers. competitors’ devices and adequately educate
their sales force and training staff.7,8

420 Biomedical Instrumentation & Technology November/December 2019


© Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.
ISO-IEC JWG 1 agreed that its approach to
the problem should be on devising the best
means of communicating a rational, func-
tional terminology structure of how the
selected settings would determine the
interaction between the patient and ventilator.
It requested that an initial discussion docu-
ment be prepared, and in February 2007, a
small group of experts (led by Dr. Norman
Jones) began preparing a suitable terminolog-
ical entry for the pending revision of IEC
60601-2-12:2001.9 (Note: This publication was
superseded by ISO 80601-2-12:2011,10 which
currently is in the final stages of a further
revision.)
Development of a Unique
International Standard
In 2008, ISO TC 121/SC 4 (Anaesthetic and
Respiratory Equipment—Vocabulary and
semantics), which had been responsible for
ISO 4135 but dormant for several years, was
reactivated. By this time, it had also become
clear that the scope of the work on ventilation
terminology needed to extend beyond its
application to critical care ventilators, to the
extent that the production of a separate
standard was justified.
Therefore, it was agreed that the working
group responsible for this work should be
under the purview of ISO/TC 121/Subcom-
mittee (SC) 4 with the objectives of compiling
a standardized vocabulary applicable to all
types of ventilators, as well as clarifying
existing terminology and its use. This new
international standard was given the designa-
tion ISO 19223.11 The intent was that the
standard would update and replace the
ventilator terminology included in ISO
4135:2001,5 with that standard then undergo-
ing revision as a distinct work item.
SC 4 involved additional experts in its work
and established a comprehensive concept
system that made extensive use of diagram-
matic tools to clearly identify the relationships
among various ventilation patterns and the
means used to artificially inflate patients'
lungs. This was used as the basis for creating
definitions that clarify both common ele-
ments and distinctions. The process included
extensive review of the scientific and medical
literature, manufacturers’ ventilator manuals
and literature used to market these devices,
ANALYSIS
and the Food and Drug Administration's
(FDA’s) Manufacturer and User Facility
Device Experience (MAUDE) database.12 The
project involved the participation of anesthesi-
ologists, intensive care physicians, respiratory
therapists, and educators, as well as informa-
tion technology, research and development,
marketing, and training experts from the lung
ventilation industry.
Multiple SC 4 meetings held over the
following decade were characterized by
scholarly and thoughtful consideration of
semantic detail, with the goal of improving
the accuracy and consistency of the vocabu-
lary. Terms such as breath, breathe, inflation,
set rate, assured inflation, and PEEP (positive
end-expiratory pressure) were discussed at
length. (Note: From this paragraph forward,
terms specifically defined in ISO 19223
appear in italics.) These discussions benefited
greatly from a landmark publication in 2012
by Morley and Keszler.13 Recognition of the
importance of this project increased as it
progressed, and the development and imple-
mentation of a standardized terminology for
ventilator technology was identified as a
primary concern during the 2014 Association
for the Advancement of Medical Instrumenta-
tion/FDA Summit on Ventilator Technology.14
Published in July 2019, ISO 19223 serves as
the outcome of this extensive work. The
standard defines and describes the use of
ventilator terminology in a manner that will
facilitate the setting of a ventilator and the
description and recording of ventilator-patient
interactions, without ambiguity, both continu-
ously and at specific points during ventilation.
Basic concepts such as baseline airway
pressure, mandatory, and spontaneous breath
are defined clearly. It is expected that the user
or operator, when familiar with the applica-
tion of this new standard, will make the
transition from one ventilator to another with
greater ease and confidence.
As it is formulated according to the require-
ments of ISO 70415 and ISO 10241-1,16 ISO
19223 (when appropriate) includes useful
notes to aid in the use of defined terms.
These provide immediately accessible
supplementary information, not only to the
reader of the standard but also to those access-
ing individual entries on the open-access ISO
Online Browsing Platform.17
www.aami.org/bit 421
ANALYSIS
© Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.

Structure both unrestricted expirations and inspirations

ISO 1922311 is divided into the following
sections, according to semantic categories:
general artificial-ventilation; breath; lung
inflation; time, phase, and cycle; rate;
pressure; flow; volume; initiation and
termination; baseline and PEEP; mode;
bi-level; safety limits and alarms; and gas
ports. The standard also includes an inform-
ative rationale and guidance annex (Annex
A) explaining the mental model of ventila-
tion used as the basis for the standard, nine
additional informative annexes (Table 1), and
a bibliography.
Mode Terminology
ISO 19223 defines a ventilation-mode as the
“specified manner in which a ventilator
performs its ventilatory function when
connected to a patient” (3.11.2).11 For each
ventilation-mode, two key characteristics
apply: (1) the method used to contribute to,
or control, the inflation of the patient’s lungs
and (2) the pattern with which these contri-
butions occur, based on time intervals or the
patient’s own respiratory activity. ISO 19223
defines these characteristics separately as
inflation-type and ventilation-pattern, respec-
tively.
Toward the end of the last century, devel-
opments in controls and sensors enabled the
introduction of adult ventilators with built-in
characteristics that enable a patient to make
at any time, even during an inflation at a
constant pressure level. Such a feature,
formerly restricted to infant ventilators and
unidentified by any specific name, has now
been formally designated as an ACAP
adjunct. (ACAP stands for “assured constant
airway pressure.”)
A key feature of ISO 19223 is the introduc-
tion of ventilation-mode groups (3.11.5), which
are “groups of ventilation-modes that share
fundamental features with respect to the
characteristics of their ventilation-patterns”
(Table 2). This system was originally intro-
duced in the early stages of the development
of the standard as a means of creating a
primary classification of the large number of
mode names used by manufacturers. As a
result of this method being considered a
highly useful method of presentation to
those being introduced to the concepts
adopted in the standard, it was included as
the top level of classification. Although
manufacturers are not required to refer to
these groups in product labeling, if a
reference is made, it must be consistent with
ISO 19223.
Education and Future Progress
ISO 19223 is expected to enable clinicians,
educators, and manufacturers to improve
and standardize training, communications,
and protocols for patients in institutional,

Annex No. Description

Annex A Rationales and guidance
Annex B Conceptual relationships between ventilator actions and types of breath
Annex C Illustrations of ventilation terms, including 35 original figures detailing ventilation concepts in graphic
form
Annex D Classification of inflation-types, including coding schemes for inflation-types and variants of volume-
control inflation-types
Annex E Classification of ventilation-modes; systematic coding schemes for ventilators both with and without
an ACAP adjunct (see Table 2)
Annex F Concepts relating to baseline airway pressures and PEEP, as used in ISO 19223, including seven
original figures illustrating these concepts
Annex G Conventions followed in ISO 19223 (e.g. typography, hyphenation, symbols)
Annex H Implementation guidance for the vocabulary of ISO 19223
Annex I Equivalence declaration tables; supplementary guidance for creating manufacturers' ventilation-mode
equivalence tables
Annex J Terminology: alphabetized index of defined terms

Table 1. Informative annexes to ISO 19223: 2019. Abbreviations used: ACAP, assured constant airway pressure; PEEP, positive end-expiratory pressure.

422 Biomedical Instrumentation & Technology November/December 2019

 ANALYSIS
© Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.

Group Description
Group 1 One inflation-type can be selected at a time.
  Group 1a No provision for the selected inflation-type to be initiated by a patient-trigger event (e.g., CMV mode).
  Group 1b Selected inflation-type is assured to be initiated at successive intervals determined by the set rate if not
initiated within such an interval by a patient-trigger event (e.g., A/C mode).
Group 2 An inflation-type is selected to be initiated at the set rate, with spontaneous breathing possible
between assured inflations (either unassisted or supported by a selected inflation-type).
  Group 2a No provision for the assured inflations to be initiated by a patient-trigger event (e.g., IMV mode).
  Group 2b The initiation of each assured inflation is synchronized with any spontaneous breathing while
maintaining the set rate (e.g., SIMV mode).
Group 3 Each patient-trigger event initiates a selected inflation-type; where a patient-trigger event does not
occur within a set time interval, the ventilator initiates a second selected inflation-type.
Group 4 Ventilation-patterns enable continuous unrestricted breathing or continuous supported breathing,
with constant baseline airway pressure at the set BAP level.
  Group 4a Group 4 ventilation-modes with a provision to support each inspiratory activity exceeding a threshold
level (e.g., CSV mode).
  Group 4b Group 4 ventilation-modes with no provision to support any inspiratory activity (e.g., CPAP ventilation-
mode).

Table 2. Ventilation-mode groups in ISO 19223:2019. Abbreviations used: A/C, assist/control ventilation; BAP, baseline airway pressure; CMV, continuous
mandatory ventilation; CPAP, continuous positive airway pressure; CSV, continuous spontaneous ventilation; IMV, intermittent mandatory ventilation; SIMV,
synchronized intermittent mandatory ventilation.

home, critical, intensive care, and emergency
care environments. As a first step in its
implementation, Annex H.111 (Table 1)
provides recommendations for initial
introduction, noting that much care has
been taken to minimize the changes faced by
most users of ventilators.
Manufacturers are encouraged to partici-
pate by preparing product documentation
identifying terms used for their current
ventilators that differ from those used to
designate the same or very similar concepts
in ISO 19223. In cases where the terms are
similar, a brief note explaining the deviation
should be provided. SC 4 recommends that
for all ventilation-modes that can be selected,
the full coded form of the systematic ventila-
tion-mode name, as specified in ISO 19223,
should be listed alongside the labeled name
used on the equipment. Brief descriptions of
the basic ventilation-modes available on the
ventilator expressed with ISO 19223 terminol-
ogy should supplement these listings. A
glossary (included in or supplementing the
accompanying documents and instructions
for use) is considered the optimal way to
make this information readily available.
To further facilitate the introduction of
this new ISO standard and its benefits to
potential users, a computer-based presenta-
tion is being developed for use at
professional society meetings, for group
training, and for personal study. Titled
Illustrated Handbook of Ventilator Vocabu-
lary, the resource will be published online
at http://ventilatorvocabulary.online.
References
1. Centers for Disease Control and Prevention. Ven-
tilator-Associated Event (VAE). Available at: www.
cdc.gov/nhsn/PDFs/pscManual/10-VAE_FINAL.
pdf. Accessed Sept. 10, 2019.
2. Minotra D, Dain SL, Burns CM. Protocol for
Usability Testing and Validation of the ISO Draft
International Standard 19223 for Lung Ventila-
tors. JMIR RES Protoc. 2017;6(9):e166.
3. The Joint Commission. Sentinel Event Data:
Root Causes by Event Type, 2004–2015. Avail-
able at: https://hcupdate.files.wordpress.
com/2016/02/2016-02-se-root-causes-by-event-
type-2004-2015.pdf. Accessed Sept. 10, 2019.
4. IEC 60601-1:2005. Medical electrical equipment–
Part 1: General requirements for basic safety and
essential performance. Geneva: International
Electrotechnical Commission.
5. ISO 4135:2001. Anaesthetic and respiratory equip-
ment–Vocabulary. Geneva: International Organi-
zation for Standardization.

www.aami.org/bit 423
ANALYSIS
© Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.

6. Chatburn RL. Classification of ventilator modes: (MAUDE). Available at: www.fda.gov/medical-de-

update and proposal for implementation. Respir
Care. 2007;52(3):301–23.
7. Chatburn RL, Volsko TA, Hazy J, et al. Deter-
mining the basis for a taxonomy of mechanical
ventilation. Respir Care. 2012;57(4):514–24.
8. Major VL, Chiew YS, Shaw GM, Chase JG. Bio-
medical engineer’s guide to the clinical aspects of
intensive care mechanical ventilation. Biomed Eng
Online. 2018;17(1):169. 31 pp.
9. IEC 60601-2-12:2001. Medical electrical equip-
ment—Part 2-12: Particular requirements for the
safety of lung ventilators--Critical care ventilators. Ge-
neva: International Electrotechnical Commission.
10. ISO 80601-2-12:2011. Medical electrical equip-
ment—Part 2-12: Particular requirements for basic
safety and essential performance of critical care
ventilators. Geneva: International Organization for
Standardization.
11. ISO 19223:2019. Lung Ventilators and related equip-
ment—Vocabulary and semantics. Geneva: Interna-
tional Organization for Standardization.
12. Food and Drug Administration. Manufacturer
and User Facility Device Experience Database
vices/mandatory-reporting-requirements-man-
ufacturers-importers-and-device-user-facilities/
manufacturer-and-user-facility-device-experi-
ence-database-maude. Accessed Sept. 10, 2019.
13. Morley CJ, Keszler M. Ventilators do not breathe.
Arch Dis Child Fetal Neonatal Ed. 2012;97:F392–4.
14. Association for the Advancement of Medical
Instrumentation, Food and Drug Administra-
tion. Creating a Culture of Safety: Priority Issues
from the 2014 AAMI/FDA Summit on Ventilator
Technology. Available at: http://s3.amazonaws.com/
rdcms-aami/files/production/public/FileDown-
loads/Summits/Ventilator/2014_Ventilator_Sum-
mit_Report.pdf. Accessed Sept. 10, 2019.
15. ISO 704:2009. Terminology work—Principles and
methods. Geneva: International Organization for
Standardization.
16. ISO 10241-1:2011. Terminological entries in stand-
ards. Geneva: International Organization for
Standardization.
17. International Organization for Standardization.
Online Browsing Platform (OBP). Available at:
www.iso.org/obp/ui. Accessed Sept. 10, 2019.

424 Biomedical Instrumentation & Technology November/December 2019

 © Copyright AAMI 2019. Single user license only. Copying, networking, and distribution prohibited.

AAMI Training
Advancing Education in Health Technology

Upcoming Courses
Ethylene Oxide Sterilization
January 14–17, 2020, Arlington, VA
Design Control Requirements – Integrating the Quality
System Regulation and ANSI/AAMI/ISO 13485
January 28–30, 2020, Arlington, VA
Human Factors for Medical Devices
February 4– 6, 2020, Arlington, VA
The Quality System Regulation 21 CFR 820 and
ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements
February 10– 14, 2020, Arlington, VA
Integrating Risk Management into the Product Lifecycle:
Quality and 13485
March 10–12, 2020, Arlington, VA

Visit www.aami.org/training
for details and to register.
www.aami.org