ISO 80601-2-72:2023
(Main)Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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; — 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. 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.
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
Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur associé à ses accessoires, ci-après désignés par appareil EM : — destiné à être utilisé dans l’environnement des soins à domicile ; — destiné à être utilisé par un opérateur non spécialiste ; et — prévu pour les patients qui nécessitent différents niveaux d’aide par ventilation artificielle, y compris pour les patients ventilo-dépendants. Le présent document s’applique également 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.
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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 2023
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ISO 80601-2-72:2023(E)
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© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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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
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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
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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
2
— harmonization with ISO 20417, where appropriate.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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 f
...
NORME ISO
INTERNATIONALE 80601-2-72
Deuxième édition
2023-06
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
Medical electrical equipment —
Part 2-72: Particular requirements for basic safety and essential
performance of home healthcare environment ventilators for
ventilator-dependent patients
Numéro de référence
ISO 80601-2-72:2023(F)
© ISO 2023
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ISO 80601-2-72:2023(F)
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Publié en Suisse
ii
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ISO 80601-2-72:2023(F)
Sommaire
Avant-propos . v
Introduction . vii
201.1 Domaine d’application, objet et normes connexes . 1
201.2 Références normatives . 4
201.3 Termes et définitions . 5
201.4 Exigences générales . 23
201.5 Exigences générales relatives aux essais des appareils EM . 27
201.6 Classification des appareils EM et des systèmes EM . 28
201.7 Identification, marquage et documentation des appareils EM . 28
201.8 Protection contre les dangers d’origine électrique des appareils EM . 38
201.9 Protection contre les dangers mécaniques des appareils EM et des systèmes EM . 38
201.10 Protection contre les dangers dus aux rayonnements involontaires ou excessifs . 40
201.11 Protection contre les températures excessives et les autres dangers . 41
201.12 Précision des commandes, des instruments et protection contre les
caractéristiques de sortie présentant des risques . 43
201.13 Situations dangereuses et conditions de défaut . 64
201.14 Systèmes électromédicaux programmables (SEMP) . 66
201.15 Construction d’un appareil EM . 67
201.16 Systèmes EM . 68
201.17 Compatibilité électromagnétique des appareils EM et des systèmes EM . 69
201.101 Raccordements des gaz . 69
201.102 Exigences relatives au VBS et ses accessoires . 72
201.103 Respiration spontanée pendant une perte d’alimentation . 74
201.104 Indication de la durée de fonctionnement . 74
201.105 Connexion fonctionnelle . 74
201.106 Affichage des boucles . 75
201.107 Sécurité du ventilateur . 76
201.108 Orifice d’entrée d’oxygène . 76
202 Perturbations électromagnétiques — Exigences et essais. 76
206 Aptitude à l’utilisation . 77
208 Exigences générales, essais et recommandations pour les systèmes d’alarme des
appareils électromédicaux et des systèmes électromédicaux . 79
211 Exigences concernant les appareils électromédicaux et les systèmes
électromédicaux utilisés dans l’environnement des soins à domicile . 81
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ISO 80601-2-72:2023(F)
Annexe C (informative) Guide pour les exigences de marquage et d’étiquetage des
appareils EM et des systèmes EM . 84
Annexe D (informative) Symboles des marquages . 92
Annexe AA (informative) Recommandations particulières et justification . 94
Annexe BB (informative) Exigences relatives à l’interface des données . 123
Annexe CC (informative) Référence aux principes essentiels et recommandations
d’étiquetage IMDRF . 132
Annexe DD (informative) Référence aux principes essentiels . 137
Annexe EE (informative) Référence aux exigences générales de sécurité et de
performances . 141
Bibliographie . 145
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ISO 80601-2-72:2023(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le
droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives ou www.iec.ch/members_experts/refdocs).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets et https://patents.iec.ch.).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www.iso.org/iso/avant-propos. Pour l'IEC, voir
www.iec.ch/understanding-standards.
Le présent document a été élaboré par le comité ISO/TC 121, Matériel d’anesthésie et de réanimation
respiratoire, sous-comité SC 3, Appareils respiratoires et équipements connexes utilisés pour les soins aux
patients et le comité technique IEC/TC 62, Équipements électriques dans la pratique médicale,
sous-comité SC 62D, Appareils électromédicaux, en collaboration avec le comité technique CEN/TC 215,
Équipement respiratoire et anesthésique, du Comité européen de normalisation (CEN), conformément à
l’Accord de coopération technique entre l’ISO et le CEN (Accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 80601-2-72:2015), qui a fait l’objet
d’une révision technique.
Les principales modifications sont les suivantes :
— ajout d’exigences relatives à l’affichage pendant l’étalonnage des moniteurs de gaz ;
— clarification des exigences de pression limitée maximale ;
— clarification des exigences de condition d’alarme de pression des voies aériennes ;
— ajout d’exigences en matière de récupération du système de ventilation ;
— ajout d’exigences en matière de réponse à une augmentation de la teneur en oxygène (O ) réglée ;
2
et
— harmonisation avec l’ISO 20417, le cas échéant.
© ISO 2023 – Tous droits réservés v
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ISO 80601-2-72:2023(F)
Une liste de toutes les parties de la série ISO 80601 et de la série IEC 80601 se trouve sur les sites web
de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/members.html et www.iec.ch/national-committees.
vi © ISO 2023 – Tous droits réservés
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ISO 80601-2-72:2023(F)
Introduction
Le présent document spécifie les exigences relatives aux ventilateurs pulmonaires destinés à être utilisés
dans l’environnement des soins à domicile pour les patients dépendants d’une ventilation pour le
maintien de leurs fonctions vitales. Ces ventilateurs sont fréquemment utilisés dans des endroits où le
réseau d’alimentation qui fait fonctionner le ventilateur n’est pas fiable. Ces ventilateurs sont souvent
surveillés par du personnel non médical (opérateurs non spécialistes) ayant des niveaux de formation
variables. Les ventilateurs pulmonaires conformes à la présente norme peuvent être utilisés ailleurs
(c’est-à-dire dans des établissements de soins).
En ce qui concerne la structure du présent document :
— «article » désigne l’une des 5 sections numérotées dans la table des matières, avec toutes ses
subdivisions (par exemple l’Article 201 inclut les paragraphes 201.7, 201.8, etc.) ; et
— «paragraphe » désigne l’une des subdivisions numérotées d’un article (par exemple, 201.7, 201.8 et
201.9 sont tous des paragraphes de l’Article 201).
Dans le présent document, les références à des articles sont précédées du mot «Article » suivi du
numéro de l’article concerné. Les références aux paragraphes du présent document sont présentées
sous forme de numéro uniquement.
Dans le présent document, la conjonction «ou » est utilisée comme « ou inclusif » ; une affirmation est
donc vraie si une combinaison quelconque des conditions est vraie.
Aux fins du présent document :
— « doit » indique une exigence ;
— « il convient de/que » indique une recommandation ;
— « peut/il est admis/permis » indique une autorisation ;
— le verbe « pouvoir » (« can » en anglais) indique une possibilité ou une capacité ; et
— l’expression « il faut » exprime une contrainte externe.
L’Annexe C contient un guide relatif aux exigences de marquage et d’étiquetage contenues dans le
présent document.
L’Annexe D contient un récapitulatif des symboles mentionnés dans le présent document.
Les exigences du présent document sont décomposées de sorte que chaque exigence soit définie
individuellement. Cette méthode vise à aider le suivi automatique des exigences.
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NORME INTERNATIONALE ISO 80601-2-72:2023(F)
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
201.1 Domaine d’application, objet et normes connexes
L’Article 1 de l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 s’applique, avec l’exception suivante :
201.1.1 Domaine d’application
Remplacement :
NOTE 1 L’Article AA.2 contient des recommandations ou justifications concernant le présent paragraphe.
Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur
associé à ses accessoires, ci-après désignés par appareil EM :
— destiné à être utilisé dans l’environnement des soins à domicile ;
NOTE 2 Dans l’environnement des soins à domicile, il est fréquent que le réseau d’alimentation qui fait fonctionner
le ventilateur ne soit pas fiable.
NOTE 3 Ces ventilateurs peuvent également être utilisés dans les établissements de santé professionnels, pour
d’autres applications qu’en soins intensifs.
— destiné à être utilisé par un opérateur non spécialiste ; et
— prévu pour les patients qui nécessitent différents niveaux d’aide par ventilation artificielle,
y compris pour les patients ventilo-dépendants.
Un ventilateur n’est pas considéré comme utilisant un système physiologique de commande en boucle
fermée, à moins qu’il n’utilise une variable physiologique du patient pour ajuster les paramètres de
traitement par ventilation.
Le présent document s’applique également 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.
EXEMPLE Tubes respiratoires, raccords, pièges à eau, valve expiratoire, humidificateur, filtre pour système
respiratoire, source électrique externe et système d’alarme réparti.
NOTE 4 Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM
ou uniquement aux systèmes EM le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est
pas le cas, l’article ou le paragraphe s’applique à la fois aux appareils EM et aux systèmes EM, suivant le cas.
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ISO 80601-2-72:2023(F)
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le
cadre du domaine d’application du présent document ne sont pas couverts par des exigences
spécifiques du présent document, à l’exception des exigences spécifiées dans
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 et 8.4.1.
NOTE 5 Des informations supplémentaires peuvent être trouvées dans
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
Le présent document ne spécifie pas les exigences relatives à ce qui suit :
— les ventilateurs ou accessoires prévus pour les applications en soins intensifs, qui sont données dans
l’ISO 80601-2-12 ;
— les ventilateurs ou accessoires prévus pour les applications en anesthésie, qui sont données dans
l’ISO 80601-2-13 ;
— les ventilateurs ou accessoires prévus pour les urgences et le transport, qui sont données dans
l’ISO 80601-2-84 ;
— les ventilateurs ou accessoires prévus pour l’équipement d’assistance ventilatoire en soins à
domicile (destinés uniquement à augmenter la ventilation des patients respirant spontanément),
qui sont données dans l’ISO 80601-2-79 et l’ISO 80601-2-80 ;
— les appareils EM de traitement de l’apnée obstructive du sommeil, qui sont données dans
l’ISO 80601-2-70 ;
— les ventilateurs à haute fréquence, indiqués dans l’ISO 80601-2-87 ;
— les appareils de traitement respiratoire à haut débit, qui sont données dans l’ISO 80601-2-90 ;
NOTE 6 Un ventilateur conforme à l’ISO 80601-2-72 peut intégrer un mode de fonctionnement de thérapie à haut
débit, mais un tel mode est uniquement réservé aux patients respirant spontanément.
— les ressuscitateurs à puissance motrice fournie par l’utilisateur, qui sont présentés dans
l’ISO 10651-4 ;
— les appareils de réanimation d’urgence alimentés par gaz, qui sont présentés dans l’ISO 10651-5 ;
— les appareils EM d’oxygénothérapie délivrant un débit constant ; et
— les ventilateurs de type cuirasse ou « poumon d’acier ».
201.1.2 Objet
Remplacement :
Le présent document a pour objet d’établir les exigences particulières de sécurité de base et de
performances essentielles d’un ventilateur, tel que défini en 201.3.217, et de ses accessoires.
Les accessoires sont inclus car il est nécessaire que leur combinaison avec le ventilateur soit sûre.
Les accessoires peuvent avoir un impact significatif sur la sécurité de base ou les performances
essentielles d’un ventilateur.
[31]
NOTE 1 Le présent document a été préparé pour traiter des principes essentiels pertinents et des
[32]
recommandations en matière d’étiquetage de l’International Medical Devices Regulators Forum (IMDRF),
comme indiqué à l’Annexe CC.
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ISO 80601-2-72:2023(F)
NOTE 2 Le présent document a été élaboré pour traiter des principes essentiels de sécurité et de performances
pertinents de l’ISO 16142-1:2016, tels qu’indiqués dans l’Annexe DD.
NOTE 3 Le présent document a été élaboré pour traiter des exigences générales pertinentes en matière de
[33]
sécurité et de performances du Règlement européen (UE) 2017/745 , telles qu’indiquées dans l’Annexe EE.
201.1.3 Normes collatérales
Amendement (ajouter après le texte existant) :
Le présent document fait référence aux normes collatérales applicables figurant dans l’Article 2 de la
norme générale et en 201.2 du présent document.
NOTE La norme générale est l’IEC 60601-1:2005+AMD1:2012+AMD2:2020.
L’IEC 60601-1-2:2014+AMD1:2020, l’IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
l’IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 et l’IEC 60601-1-11:2015+AMD1:2020 s’appliquent
telles que modifiées dans les Articles 202, 206, 208 et 211, respectivement. L’IEC 60601-1-3,
IEC 60601-1-9 et l’IEC 60601-1-12 ne s’appliquent pas.
201.1.4 Normes particulières
Remplacement :
Dans la série IEC 60601, les normes particulières peuvent modifier, remplacer ou supprimer des
exigences contenues dans la norme générale, y compris dans les normes collatérales, suivant le cas pour
l’appareil EM spécifique considéré et elles peuvent ajouter d’autres exigences de sécurité de base ou de
performances essentielles.
Une exigence d’une norme particulière prévaut sur l’exigence correspondante de
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou d’une norme collatérale.
Par souci de concision, l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 est appelée « la norme générale »
dans le présent document. Il est fait référence aux normes collatérales par leur numéro de document.
La numérotation des articles et des paragraphes du présent document correspond à celle de la norme
générale avec le préfixe « 201 » (par exemple, 201.1 du présent document reprend le contenu de
l’Article 1 de la norme générale) ou de la norme collatérale applicable avec le préfixe « 2xx », où xx
correspond aux derniers chiffres du numéro de document de la norme collatérale (par exemple, 202.4
reprend le contenu de l’Article 4 de la norme collatérale IEC 60601-1-2, 208.4 reprend le contenu de
l’Article 4 de la norme collatérale IEC 60601-1-8, etc.). Les modifications apportées au texte de la norme
générale sont spécifiées à l’aide des termes suivants :
— « Remplacement » signifie que l’article ou le paragraphe de
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou de la norme collatérale applicable est
intégralement remplacé par le texte du présent document ;
— « Ajout » signifie que le texte de la présente norme particulière est ajouté aux exigences de
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou de la norme collatérale applicable ;
— « Amendement » signifie que l’article ou le paragraphe de
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou de la norme collatérale applicable est amendé
comme indiqué par le texte du présent document.
Les paragraphes ou figures qui s’ajoutent à ceux de la norme générale sont numérotés à partir de
201.101. Toutefois, compte tenu du fait que les définitions données dans la norme générale sont
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ISO 80601-2-72:2023(F)
numérotées de 3.1 à 3.154, les définitions supplémentaires apparaissant dans le présent document sont
numérotées à partir de 201.3.201. Les annexes supplémentaires sont indiquées par les lettres AA, BB,
etc., et les éléments supplémentaires par aa), bb), etc.
Les paragraphes ou figures qui s’ajoutent à ceux d’une norme collatérale sont numérotés à partir
de 20x, où « x » est le numéro de la norme collatérale (202 pour l’IEC 60601-1-2, 203 pour
l’IEC 60601-1-3, etc., par exemple).
L’expression « le présent document » permet de faire référence en même temps à
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020, aux normes collatérales applicables et au présent
document.
En l’absence d’article ou de paragraphe correspondant dans le présent document, l’article ou le
paragraphe de l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou de la norme collatérale applicable,
même s’il n’est pas pertinent, s’applique sans modification. S’il est prévu de ne pas appliquer les parties
de l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ou de la norme collatérale applicable, même si elles
sont pertinentes, une instruction à cet effet est donnée dans le présent document.
201.2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s’applique (y compris les
éventuels amendements).
ISO 32:1977, Bouteilles à gaz pour usages médicaux — Marquage pour l’identification du contenu.
ISO 3744:2010, Acoustique — Détermination des niveaux de puissance acoustique et des niveaux d’énergie
acoustique émis par les sources de bruit à partir de la pression acoustique — Méthodes d’expertise pour
des conditions approchant celles du champ libre sur plan réfléchissant.
ISO 4871:1996, Acoustique — Déclaration et vérification des valeurs d’émission sonore des machines et
équipements.
ISO 5356-1:2015, Matériel d’anesthésie et de réanimation respiratoire — Raccords coniques — Partie 1 :
Raccords mâles et femelles.
ISO 5359:2014+AMD1:2017, Flexibles de raccordement à basse pression pour utilisation avec les gaz
médicaux.
ISO 5367:2014, Matériel d’anesthésie et de réanimation respiratoire — Systèmes respiratoires et raccords.
ISO 7396-1:2016+AMD1:2017, Systèmes de distribution de gaz médicaux — Partie 1 : Systèmes de
distribution de gaz médicaux comprimés et de vide.
ISO 9360-1:2000, Matériel d’anesthésie et de réanimation respiratoire — Échangeurs de chaleur et
d’humidité (ECH) utilisés pour humidifier les gaz respirés par les êtres humains — Partie 1 : ECH pour
utilisation avec des volumes courants d’au moins 250 ml.
ISO 9360-2:2001, Matériel d’anesthésie et de réanimation respiratoire — Échangeurs de chaleur et
d’humidité (ECH) utilisés pour humidifier les gaz respirés par les êtres humains — Partie 2 : ECH pour
utilisation avec des patients trachéotomisés ayant des volumes courants d’au moins 250 ml.
4 © ISO 2023 – Tous droits réservés
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ISO 80601-2-72:2023(F)
ISO 14937:2009, Stérilisation des produits de santé — Exigences générales pour la caractérisation d’un
agent stérilisant et pour la mise au point, la validation et la vérification de routine d’un processus de
stérilisation pour dispositifs médicaux.
ISO 17664-1:2021, Traitement de produits de soins de santé — Informations relatives au traitement des
dispositifs médicaux à fournir par le fabricant du dispositif — Partie 1 : Dispositifs médicaux critiques et
semi-critiques.
ISO 17664-2:2021, Traitement de produits de soins de santé — Informations relatives au traitement des
dispositifs médicaux à fournir par le fabricant du dispositif — Partie 2 : Dispositifs médicaux non critiques.
ISO 18562-1:2017, Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications
de soins de santé — Partie 1 : Évaluation et essais au sein d’un processus de gestion du risque.
ISO 20417:2021, Dispositifs médicaux — Informations à fournir par le fabricant.
ISO 23328-1:2003, Filtres pour matériel d’anesthésie et de réanimation respiratoire — Partie 1 :
Méthode d’essai à l’aide d’une solution saline pour l’évaluation de l’efficacité de filtration.
ISO 23328-2:2002, Filtres pour matériel d’anesthésie et de réanimation respiratoire — Partie 2 :
Aspects autres que la filtration.
ISO 80369-1:2018, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 1 : Exigences générales.
ISO 80601-2-55:2018, Appareils électromédicaux — Partie 2-55 : Exigences particulières relatives à la
sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires.
ISO 80601-2-74:2021, Appareils électromédicaux — Partie 2-74 : Exigences particulières pour la sécurité
de base et les performances essentielles des équipements d’humidification respiratoire.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Appareils électromédicaux — Partie 1 :
Exigences générales pour la sécurité de base et les performances essentielles.
IEC 61672-1:2013, Électroacoustique — Sonomètres — Partie 1 : Spécifications.
IEC 62304:2006+AMD1:2015, Logiciels de dispositifs médicaux — Processus du cycle de vie du logiciel.
IEC 62570:2014, Pratiques normalisées relatives au marquage des appareils médicaux et des éléments de
sûreté divers dédiés aux environnements de résonance magnétique.
IEC 81001-5-1:2021, Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI de santé —
Partie 5-1: Sûreté — Activités du cycle de vie du produit.
IEC Guide 115:2021, Application de l’incertitude de mesure aux activités d’évaluation de la conformité
dans le secteur électrotechnique.
201.3 Termes et définitions
Pour les besoins du présent document, les termes et les définitions de
l’IEC 60601-1:2005+AMD1:2012+AMD2:2020 ainsi que les suivants, s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes :
© ISO 2023 – Tous droits réservés 5
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ISO 80601-2-72:2023(F)
— ISO Online browsing platform : disponible à l’adresse https://www.iso.org/obp ;
— IEC Electropedia : disponible à l’adresse https://www.electropedia.org/.
201.3.201
informations d’accompagnement
informations accompagnant ou marquées sur un dispositif médical ou un accessoire à destination de
l’utilisateur ou des personnes responsables de l’installation, de l’utilisation, du traitement, de la
maintenance, de la mise en service et de la mise au rebut du dispositif médical ou de l’accessoire,
en particulier concernant une utilisation sûre
Note 1 à l’article : Les informations d’accompagnement doivent être considérées comme faisant partie intégrante
du dispositif médical ou de l’accessoire.
Note 2 à l’article : Les informations d’accompagnement peuvent consister en une étiquette, un marquage,
des instructions d’utilisation, une description technique, un manuel d’installation, un guide de référence rapide, etc.
Note 3 à l’article : Les informations d’accompagnement ne sont pas nécessairement écrites ou imprimées
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 80601-2-72
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-72:
2023-01-26
Particular requirements for basic
Voting terminates on:
safety and essential performance
2023-03-23
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 80601-2-72:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
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ISO/FDIS 80601-2-72:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 80601-2-72
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-72:
Particular requirements for basic
Voting terminates on:
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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ISO/FDIS 80601-2-72:2023(E)
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LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
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ISO/FDIS 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 . 37
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
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ISO/FDIS 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
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ISO/FDIS 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 compared to the previous edition are as follows:
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
2
— harmonization with ISO 20417, where appropriate.
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ISO/FDIS 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
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ISO/FDIS 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 for 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.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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.
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ISO/FDIS 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.
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ISO/FDIS 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.
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ISO/FDIS 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
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ISO/FDIS 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.
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ISO/FDIS 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
...
© ISO/IEC 2023 – All rights reserved
ISO/TC 121/SC 3/
Date: 2022-12-052023-01-10
ISO 80601-2-72 (Ed 2)
ISO/IEC TC 121/SC 3/JWG 12
Secretariat: ANSI
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 d'environnement de soins de santé à domicile pour les
patients qui en sont dépendants
FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is
subject to change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.
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ISO/FDIS 80601-2-72:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland.
ii © ISO/IEC 2023 – All rights reserved
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ISO/FDIS 80601-2-72:2023(E)
Contents Page
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 . 37
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
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ISO/FDIS 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
CS will add the contents table at the FDIS stage.
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ISO/FDIS 80601-2-72:2023(E)
Foreword
ISO (the International Organization for Standardization) is a and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide federation of national
standardsstandardization. National bodies (that are members of ISO member bodies). The workor IEC
participate in the development 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. Internationalby 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. 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 documentsdocument 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 compared to the previous edition are as follows:
The most significantmain changes are the following modificationsas 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
2
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ISO/FDIS 80601-2-72:2023(E)
— harmonization with ISO 20417, where appropriate.
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO websiteand
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.
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ISO/FDIS 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 for 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.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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.
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ISO/FDIS 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.
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ISO/FDIS 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 wholethe text in such a way that some or in part, are
normatively referenced inall of their content constitutes requirements of this document and are
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ISO/FDIS 80601-2-72:2023(E)
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
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
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ISO/FDIS 80601-2-72:2023(E)
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
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]
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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.
[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
...
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