EN ISO 80601-2-72:2023

SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 80601-2-72:2015
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu
(ISO 80601-2-72:2023)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom
Gerät abhängige Patienten (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans l'environnement des soins
à domicile pour les patients ventilo-dépendants (ISO 80601-2-72:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-72:2023
ICS:
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 80601-2-72
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-72:2015
English Version
Medical electrical equipment - Part 2-72: Particular
requirements for basic safety and essential performance of
home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences Medizinische elektrische Geräte - Teil 2-72: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von
dans l'environnement des soins à domicile pour les Heimbeatmungsgeräten für vom Gerät abhängige
patients ventilo-dépendants (ISO 80601-2-72:2023) Patienten (ISO 80601-2-72:2023)
This European Standard was approved by CEN on 24 April 2023.

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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-72:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-72:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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.
This document supersedes EN ISO 80601-2-72:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-72:2023 has been approved by CEN as EN ISO 80601-2-72:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-72
Second edition
2023-06
Medical electrical equipment —
Part 2-72:
Particular requirements for basic
safety and essential performance
of home healthcare environment
ventilators for ventilator-dependent
patients
Appareils électromédicaux —
Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans
l'environnement des soins à domicile pour les patients ventilo-
dépendants
Reference number
ISO 80601-2-72:2023(E)
ISO 80601-2-72:2023(E)
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-72:2023(E)
Contents
Foreword . v
Introduction . vii
201.1 Scope, object, and related standards. 1
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 21
201.5 General requirements for testing of ME equipment . 25
201.6 Classification of ME equipment and ME systems . 26
201.7 ME equipment identification, marking, and documents . 26
201.8 Protection against electrical hazards from ME equipment. 35
201.9 Protection against mechanical hazards of ME equipment and ME systems . 35
201.10 Protection against unwanted and excessive radiation hazards . 37
201.11 Protection against excessive temperatures and other hazards . 38
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 40
201.13 Hazardous situations and fault conditions . 59
201.14 Programmable electrical medical systems (PEMS) . 61
201.15 Construction of ME equipment . 61
201.16 ME systems . 62
201.17 Electromagnetic compatibility of ME equipment and ME systems . 63
201.101 Gas connections . 63
201.102 Requirements for the VBS and accessories . 66
201.103 Spontaneous breathing during loss of power supply . 67
201.104 Indication of duration of operation . 68
201.105 Functional connection . 68
201.106 Display loops . 69
201.107 Ventilator security . 69
201.108 Oxygen inlet port . 70
202 Electromagnetic disturbances — Requirements and tests . 70
206 Usability . 71
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 73
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 75
ISO 80601-2-72:2023(E)
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 78
Annex D (informative) Symbols on marking . 85
Annex AA (informative) Particular guidance and rationale . 87
Annex BB (informative) Data interface requirements . 113
Annex CC (informative) Reference to the IMDRF essential principles and labelling
guidances . 121
Annex DD (informative) Reference to the essential principles . 126
Annex EE (informative) Reference to the general safety and performance requirements . 130
Bibliography . 134

iv © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
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 document 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 or
www.iec.ch/members_experts/refdocs).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC 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) or the
IEC list of patent declarations received (see https://patents.iec.ch).
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. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D,
Electric equipment, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80601-2-72:2015), which has been
technically revised.
The main changes are as follows:
— added requirements for display during calibration of gas monitors;
— clarified maximum limited pressure requirements;
— clarified high airway pressure alarm condition requirements;
— added requirements for ventilator system recovery;
— added requirements for response to an increase in set oxygen (O ) concentration; and
— harmonization with ISO 20417, where appropriate.
ISO 80601-2-72:2023(E)
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO and IEC
websites.
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 and www.iec.ch/national-
committees.
vi © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
Introduction
This document specifies requirements for lung ventilators that are intended for use in the home
healthcare environment for patients who are dependent on ventilation for their life support. These
ventilators are frequently used in locations where the supply mains driving the ventilator is not reliable.
These ventilators are often supervised by non-healthcare personnel (lay operators) with varying levels
of training. Lung ventilators conforming with this standard can be used elsewhere (i.e. in healthcare
facilities).
In referring to the structure of this document,
— “clause” means one of the 5 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes 201.7, 201.8, etc.); and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this document are by number only.
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.
For the purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
Requirements in this document have been decomposed so that each requirement is uniquely
delineated. This is done to support automated requirements tracking.

INTERNATIONAL STANDARD ISO 80601-2-72:2023(E)

Medical electrical equipment —
Part 2-72:
Particular requirements for basic safety and essential
performance of home healthcare environment ventilators for
ventilator-dependent patients
201.1 Scope, object, and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of a ventilator in combination with
its accessories, hereafter referred to as ME equipment:
— intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilator is often not reliable.
NOTE 3 Such ventilators can also be used in non-critical care applications of professional healthcare facilities.
— intended for use by a lay operator; and
— intended for those patients who need differing levels of support from artificial ventilation including
for ventilator-dependent patients.
A ventilator is not considered to use a physiologic closed-loop control system unless it uses a
physiological patient variable to adjust the ventilation therapy settings.
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.
EXAMPLE Breathing tubes, connectors, water traps, expiratory valve, humidifier, breathing system filter,
external electrical power source, and distributed alarm system.
NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only or to ME systems
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except for the
requirements specified in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
ISO 80601-2-72:2023(E)
This document does not specify the requirements for:
— ventilators or accessories intended for critical care applications, which are given in ISO 80601-2-12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;
— ventilators or accessories intended for emergency and transport which are given in ISO 80601-2-84;
— ventilators or accessories intended for homecare ventilatory support equipment (intended only to
augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79
and ISO 80601-2-80;
— obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
— high-frequency ventilators, which are given in ISO 80601-2-87.
— respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;
NOTE 6 An ISO 80601-2-72 ventilator can incorporate high-flow therapy operational mode, but such a mode is
only for spontaneously breathing patients.
— user-powered resuscitators, which are given in ISO 10651-4;
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— oxygen therapy constant flow ME equipment; and
— cuirass and “iron-lung” ventilators.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance
requirements for a ventilator, as defined in 201.3.217, and its accessories.
Accessories are included because the combination of the ventilator and the accessories needs to be
adequately safe. Accessories can have a significant impact on the basic safety or essential performance of
a ventilator.
[31] [32]
NOTE 1 This document has been prepared to address the relevant essential principles and labelling
guidance of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex DD.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements
[33]
of European regulation (EU) 2017/745 as indicated in Annex EE.
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and in 201.2 of this document.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
2 © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 and IEC 60601-1-11:2015+AMD1:2020 apply as
modified in Clauses 202, 206, 208 and 211 respectively. IEC 60601-1-3, IEC 60601-1-9 and
IEC 60601-1-12 do not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards can modify, replace, or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME equipment
under consideration, and may add other basic safety or essential performance requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005+AMD1:2012+AMD2:2020
or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of
the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601-1-2, Clause 4
collateral standard, 208.4 addresses the content of IEC 60601-1-8, Clause 4 collateral standard, etc.).
The changes to the text of the general standard are specified by the use of the following words:
— “Replacement” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020
or the applicable collateral standard is replaced completely by the text of this document.
— “Addition” means that the text of this particular standard is additional to the requirements of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard.
— “Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020
or the applicable collateral standard is amended as indicated by the text of this document.
Subclauses or figures that are additional to those of the general standard are numbered starting from
201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201. Additional
annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for
IEC 60601-1-3, etc.
The term “this document” is used to make reference to IEC 60601-1:2005+AMD1:2012+AMD2:2020,
any applicable collateral standards, and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
not relevant, applies without modification; where it is intended that any part of
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly
relevant, is not to be applied, a statement to that effect is given in this document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 80601-2-72:2023(E)
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5359:2014+AMD1:2017, Low-pressure hose assemblies for use with medical gases
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical
device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors
ISO 80601-2-74:2021, Medical electrical equipment — Part 2-74: Particular requirements for basic safety
and essential performance of respiratory humidifying equipment
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62304:2006+AMD1:2015, Medical device software - Software life cycle processes
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
4 © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security — Part 5-1:
Security — Activities in the product life cycle
IEC Guide 115:2021, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
201.3.201
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
201.3.202
acknowledged
state of an alarm system initiated by operator action, where the auditory alarm signal associated with a
currently active alarm condition is inactivated until the alarm condition no longer exists or until a
predetermined time interval has elapsed
Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.37]
201.3.203
airway device
device intended to provide a gas pathway to and from the patient’s airway
[SOURCE: ISO 4135:2022, 3.8.1.2]
201.3.204
airway pressure
P
aw
pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
connection port
Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the
equipment.
ISO 80601-2-72:2023(E)
[SOURCE: ISO 4135:2022, 3.1.4.41.1]
201.3.205
alarm condition delay
time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or
in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm
condition exists
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.2]
201.3.206
alarm limit
threshold used by an alarm system to determine an alarm condition
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.207
alarm off
state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.4]
201.3.208
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm
signals
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
201.3.209
alarm setting
alarm system configuration, including but not limited to:
– alarm limits;
– the characteristics of any alarm signal inactivation states; and
– the values of variables or parameters that determine the function of the alarm system
Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-
determined.
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.8]
201.3.210
alarm signal generation delay
time from the onset of an alarm condition to the generation of its alarm signal(s)
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.10]
201.3.211
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 ventilation are manual resuscitation; mouth-to-mouth
resuscitation; automatic ventilation; mechanical ventilation.
6 © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport;
home-care; anaesthesia; critical care; rehabilitation.
Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure;
negative-pressure; gas-powered; operator-powered; electrically-powered.
Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently
lowering the pressure in the lungs.
[SOURCE: ISO 19223:2019, 3.1.10]
201.3.212
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use
of an asset
[SOURCE: IEC 81001-5-1:2021, 3.5]
201.3.213
audio off
state of indefinite duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.12]
201.3.214
audio paused
state of limited duration in which the alarm system or part of the alarm system does not generate an
auditory alarm signal
[SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
201.3.215
BAP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
[SOURCE: ISO 19223:2019, 3.10.2, modified — deleted notes.]
201.3.216
bias flow
flow that passes through the ventilator breathing system to the exhaust port but is not intended to
contribute to the work of lung ventilation
[SOURCE: ISO 19223:2019, 3.7.7, modified — deleted notes.]
201.3.217
biocompatibility
ability to be in contact with a living system without producing an unacceptable adverse effect
Note 1 to entry: Medical devices may produce some level of adverse effect, but that level may be determined to be
acceptable when considering the benefits provided by the medical device.
[SOURCE: ISO 18562-1:2017, 3.2]
ISO 80601-2-72:2023(E)
201.3.218
body temperature and pressure saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and at a relative humidity of 100 %
[SOURCE: ISO 4135:2022, 3.1.1.7]
201.3.219
breathing system
pathways through which gas flows to or from the patient at respiratory pressures and continuously or
intermittently in fluid communication with the patient’s respiratory tract during any form of artificial
ventilation or respiratory therapy
[SOURCE: ISO 4135:2022, 3.6.1.1, modified — deleted notes.]
201.3.220
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in breathing systems
[SOURCE: ISO 23328-2:2002, 3.1]
201.3.221
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other
debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated
process that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
201.3.222
connector
fitting to join two or more components
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each
particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
201.3.223
continuous flow
gas flowing continuously through the ventilator breathing system, with a proportion intermittently
passing to the patient's lung whenever the airway pressure is raised by the ventilator or an operator
action, or flow is demanded by a patient's inspiratory effort
[SOURCE: ISO 19223:2019, 3.7.8, modified — deleted notes.]
201.3.224
CPAP
continuous positive airway pressure
ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously
at a set airway-pressure level, above ambient pressure
8 © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
Note 1 to entry: CPAP is intended to maintain the airway pressure at its set value apart from the inevitable minor
deviations that are necessary for it to perform its function. Although there are currently no tests for acceptable
levels for such deviations, they are expected to neither add to nor subtract from the patient's perceived work of
breathing to a greater extent than could be experienced during natural breathing.
Note 2 to entry: This definition excludes the use of the term to describe ventilation-modes where spontaneous
inspirations are supported by intermittently elevated pressures other than with the intention to compensate for
any actual or perceived imposed work of breathing.
Note 3 to entry: Because, as used for this ventilation-mode, the concept of a CPAP level coincides with that of a
baseline airway pressure the setting could be designated as for either concept but as the intention of the operator
selecting this ventilation-mode will be to achieve a specific CPAP level, this becomes an acceptable admitted term
to designate the set quantity.
Note 4 to entry: Although at the periphery of the spectrum of what constitutes a ventilation-mode, CPAP is
included in this document because it is commonly made available on typical critical care ventilators for use as part
of a continuum of a patient's treatment without the necessity to change to another device.
Note 5 to entry: It is possible for a ventilation-mode resembling CPAP to be realized on a ventilator by the use of
CSV (continuous spontaneous ventilation) with the pressure-support (PS) set to ‘zero’ or ‘none’ but CSV set in this
way is not equivalent to CPAP if its performance in response to a spontaneous inspiration is dependent on the
setting of an appropriate trigger level.
Note 6 to entry: On ventilators equipped with ACAP, this adjunct will enable unrestricted breathing whenever
CPAP is selected.
Note 7 to entry: CPAP is a Group 4b ventilation-mode. Because no inflation-type is selected this ventilation-mode is
identical to its ventilation-pattern and there is no necessity to distinguish between them. The systematic
ventilation-mode name becomes, therefore, simply, CPAP. On ventilators where CPAP is enabled by means of an
ACAP adjunct the systematic code is CPAP .
Note 8 to entry: When used for sleep-apnoea breathing-therapy, CPAP is not classed as a ventilation-mode – it
becomes a sleep-apnoea breathing-therapy mode. Although the principle clinical intention of such a therapy mode
is to maintain a positive pressure in the patient's airway during sleep in order prevent airway obstruction by the
soft tissues in the throat it has become a common practice to reduce this pressure during expiration, principally to
improve patient acceptability. Ventilation-modes with this feature are typically identified with names that allude to
this use of two levels of positive airway pressure. The generic name adopted for the designation of such a
breathing-therapy mode in this document is bi-level PAP.
[SOURCE: ISO 19223:2019, 3.11.15, modified — deleted note 9.]
201.3.225
cybersecurity
state where information and systems are protected from unauthorized activities, such as access, use,
disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle
[SOURCE: IEC 81001-5-1:2021, 3.30]
201.3.226
Δ inspiratory pressure
differential airway pressure relative to baseline airway pressure during an inflation phase
[SOURCE: ISO 19223:2019, 3.6.7, modified — deleted notes.]
ISO 80601-2-72:2023(E)
201.3.227
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
[SOURCE: ISO 17664-1:2021, 3.3]
201.3.228
distributed alarm system
DAS
alarm system that involves more than one item of equipment of a ME system intended for delivery of
alarm conditions with technical confirmation
Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.
Note 3 to entry: For the purposes of this document, technic
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