ISO 80601-2-67
(Main)Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). 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 in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
Appareils électromédicaux — Partie 2-67: Exigences particulières pour la sécurité de base et les performances essentielles des économiseurs d'oxygène
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente et synchronisée en suivant le cycle d'inspiration du patient, pour une utilisation dans l'environnement de soins à domicile. L'économiseur d'oxygène est habituellement utilisé par un opérateur non spécialiste. NOTE 1 Un économiseur peut également être utilisé dans des établissements de santé. Le présent document s'applique également aux économiseurs intégrés à d'autres appareils. EXEMPLE Économiseur associé à un détendeur[2], un concentrateur d'oxygène[7] ou un appareil à oxygène liquide[4]. Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un économiseur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'économiseur. Le présent document vise à préciser les différences de fonctionnement entre différents modèles d'économiseurs, ainsi que les différences de fonctionnement entre économiseurs et appareils à oxygène à débit continu, en exigeant des essais de performance et un étiquetage normalisés. Le présent document ne s'applique qu'aux dispositifs actifs (par exemple, dotés d'une alimentation pneumatique ou électrique) et ne s'applique pas aux dispositifs non actifs (par exemple, canules de réservoir). Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas. 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 contenues dans le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1:2012, 7.2.13 et 8.4.1. NOTE 2 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.
General Information
Relations
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS
80601-2-67
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-67:
Voting begins on:
2025-10-07
Particular requirements for basic
safety and essential performance of
Voting terminates on:
2025-12-02
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
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IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO/FDIS 80601-2-67:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 80601-2-67:2025(en)
International
Standard
ISO/FDIS
80601-2-67
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-67:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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ISO/FDIS 80601-2-67:2025(en) © ISO 2025
ii
ISO/FDIS 80601-2-67:2025(en)
Contents Page
Foreword . iv
Introduction . vi
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 13
201.5 General requirements for testing of ME equipment . 16
201.6 Classification of ME equipment and ME systems . 17
201.7 ME equipment identification, marking and documents . 17
201.8 Protection against electrical hazards from ME equipment . 24
201.9 Protection against mechanical hazards of ME equipment and ME systems . 24
201.10 Protection against unwanted and excessive radiation hazards . 24
201.11 Protection against excessive temperatures and other hazards . 24
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 26
201.13 Hazardous situations and fault conditions . 29
201.14 Programmable electrical medical systems (PEMS) . 29
201.15 Construction of ME equipment . 30
201.16 ME systems . 30
201.17 Electromagnetic compatibility of ME equipment and ME systems. 31
201.101 Gas connections. 31
201.102 Requirements for parts and accessories . 32
201.103 Oxygen pressure regulators . 33
202 Electromagnetic disturbances – Requirements and tests . 34
202.4.3.1 Configurations . 34
206 Usability . 34
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 36
Annex D (informative) Symbols on marking . 41
Annex AA (informative) Particular guidance and rationale . 42
Annex BB (informative) Reference to the IMDRF essential principles and labelling
guidances . 51
Annex CC (informative) Terminology — Alphabetized index of defined terms . 55
Bibliography . 58
iii
ISO/FDIS 80601-2-67:2025(en)
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).
ISO and IEC draw attention to the possibility that the implementation of this document may involve
the use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability
of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and
IEC had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may
be obtained from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO
and IEC shall not be held responsible for identifying any or all such patent rights.
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 jointly 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, Medical equipment, software, and systems, Subcommittee SC D,
Particular medical equipment, software, and systems, 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 third edition cancels and replaces the second edition (ISO 80601-2-67:2020), which has been
technically revised.
The main changes are as follows:
— updated references, where appropriate;
— harmonization with ISO 20417, where appropriate;
— updated uncertainty of measurement requirements;
— added marking requirements for gas intake port, external gas sources and MR compatibility;
— requirements for processing of the enclosure;
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ISO/FDIS 80601-2-67:2025(en)
— added cybersecurity recommendations; and
— updated connector requirements.
A list of all parts in the ISO 80601 and 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.
v
ISO/FDIS 80601-2-67:2025(en)
Introduction
Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen
and oxygen from an oxygen concentrator.
Most clinicians prescribe low flow oxygen therapy as continuous flow oxygen (CFO) delivery in l/min.
CFO systems deliver the flow of oxygen without regard for the patient’s breathing rate or pattern.
Outside of the institutional care setting, the provision of CFO therapy is often a significant expense and
can limit the mobility of a patient to the immediate vicinity of a stationary or fixed oxygen delivery
system. To support mobility, patients use CFO from portable liquid or compressed oxygen systems
with a limited storage capacity that can limit a patient’s time and activities while away from a
stationary oxygen supply.
Conserving equipment that delivers supplemental oxygen as a bolus conserves usage while allowing
satisfactory patient arterial oxygen saturation (SaO ) to be maintained during daily activities.
Conserving equipment delivers supplemental oxygen unlike CFO in that the therapy gas flow is
delivered only during the inspiratory phase of the breathing cycle, when it is most likely to reach the
alveoli. During both the expiratory and pause phase of the breathing cycle, the flow of supplemental
oxygen is stopped, minimizing waste. Because flow over time produces a volume, the bolus delivered
by the conserving equipment is typically represented as a volume of gas. Therapy using conserving
equipment versus CFO results in lower operating costs and longer ambulatory times for patients using
the same CFO storage capacity.
Operation of conserving equipment from various manufacturers can differ in the dose delivery
mechanism resulting in variations in oxygen therapy to the patient. The use of CFO numerical
markings for dose settings on conserving equipment can not directly correlate with CFO settings and
can lead to misinterpretation of gas delivery rates and volumes for a particular patient. This can result
in incorrect patient setup and therapy delivery over all breathing rates and patterns versus CFO.
Because of the differences in delivery, settings, and markings versus CFO therapy, conserving
equipment use has requirements for patient titration to determine the proper setting(s) needed to
provide adequate SaO levels for the patient breathing patterns.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in Clause 3 of the general standard, in this particular document or as noted: italic type;
and
informative material appearing outside of tables, such as notes, examples and references: in smaller type.
—
Normative text of tables is also in a smaller type.
In referring to the structure of this document, the term.
— “clause” means one of the three numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 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 particular document are by number only.
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ISO/FDIS 80601-2-67:2025(en)
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 requirement or a test is 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.
vii
FINAL DRAFT International Standard ISO/FDIS 80601-2-67:2025(en)
Medical electrical equipment —
Part 2-67:
Particular requirements for basic safety and essential
performance of oxygen conserving equipment
201.1 Scope, object and related standards
NOTE 1 There is guidance or rationale for this clause contained in Clause AA.2.1.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE 2 The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:
This document is applicable to the basic safety and essential performance of oxygen conserving
equipment, hereafter referred to as ME equipment, in combination with its accessories intended to
conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's
inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is
typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
[4] [12]
EXAMPLE Conserving equipment combined with a pressure regulator , an oxygen concentrator or liquid
[7]
oxygen equipment .
This document is also applicable to those accessories intended by their manufacturer to be connected
to conserving equipment, where the characteristics of those accessories can affect the basic safety or
essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment
models, as well as between the operation of conserving equipment and continuous flow oxygen
equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is
not applicable to non-active devices (e.g. reservoir cannulas).
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.
ISO/FDIS 80601-2-67:2025(en)
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 in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
201.1.2 Object
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance
requirements for conserving equipment [as defined in 201.3.207] and its accessories.
NOTE 1 Accessories are included because accessories can have a significant impact on the basic safety or
essential performance of conserving equipment.
[17]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
[18]
principles guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in
Annex BB.
NOTE 3 This document has been prepared to address the relevant general safety and performance
[16]
requirements of European regulation (EU) 2017/745 .
201.1.3 Collateral standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:
IEC 60601-1-2+AMD1:2020 and IEC 60601-1-6+AMD1:2013+AMD2:2020 apply as modified in
Clauses 202 and 206 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards define basic safety and essential performance
requirements, and may modify, replace or delete requirements contained in the general standard and
collateral standards as appropriate for the particular ME equipment under consideration.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1+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 that 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 “20x”, where x is the final digit(s) of the
collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 206.4 in this document addresses the content of Clause 4 of the
IEC 60601-1-6 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 the general standard or applicable collateral
standard is replaced completely by the text of this document.
ISO/FDIS 80601-2-67:2025(en)
"Addition" means that the text of this document is additional to the requirements of the general
standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which 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, figures or tables which 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, 206
for IEC 60601-1-6, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the
general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or 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.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Addition:
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 5359:2014+AMD1:2017, Low-pressure hose assemblies for use with medical gases
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
ISO 10524-3:2019, Pressure regulators for use with medical gases — Part 3: Pressure regulators
integrated with cylinder valves (VIPRs)
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/FDIS 80601-2-67:2025(en)
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 18562-1:2024, 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 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in
the electrotechnical sector
EN 13544-2:2002+AMD1:2009, Respiratory therapy equipment — Part 2: Tubing and connectors
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 http://www.electropedia.org/
NOTE An alphabetized index of defined terms is found in Annex CC.
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 can 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 — replaced "could" with "can" and deleted note 4.]
Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2024.
ISO/FDIS 80601-2-67:2025(en)
201.3.202
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]
201.3.203
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized
use of an asset
[SOURCE: IEC 81001-5-1:2021, 3.5]
201.3.204
biocompatibility
ability of a medical device, accessory or material to perform with an appropriate host response in a
specific application
Note 1 to entry: A medical device or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefits provided by the medical device or accessory.
[SOURCE: ISO 18562-1:2024, 3.6]
201.3.205
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other
debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated
process that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
201.3.206
connector
fitting to join two or more components
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each
particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
201.3.207
conserving equipment
ME equipment intended to conserve supplemental oxygen by delivering gas intermittently and
synchronized with the patient's inspiratory cycle
Note 1 to entry: Conserving equipment can be electrically or pneumatically powered.
ISO/FDIS 80601-2-67:2025(en)
201.3.208
conserving equipment with monitoring function
conserving equipment suitable for use with patients where monitoring of oxygen delivery via the
conserving equipment is indicated
201.3.209
cybersecurity
state where information and systems are protected from unauthorized activities, such as access, use,
disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
confidentiality, integrity, and availability are maintained at an acceptable level throughout the life
cycle
[SOURCE: IEC 81001-5-1:2021, 3.30]
201.3.210
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 17664-2:2021, 3.5]
201.3.211
essential function
function or capability that is required to maintain basic safety, essential performance, a minimum of
clinical functionality as specified by the manufacturer, and operational availability for the medical
device
Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety
and essential performance), the control function and the availability of urgently needed functions and such
allowing the operator to view and manipulate the medical device safely with the most urgently needed
performance (operational availability). The loss of essential function is commonly termed loss of protection, loss
of control and loss of view respectively.
Note 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose and
scope of this document.
[SOURCE: IEC/TR 60601-4-5:2021, 3.10]
201.3.212
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a medical device is safe and
performs as intended
[SOURCE: ISO 16142-1:2016, 3.3]
ISO/FDIS 80601-2-67:2025(en)
201.3.213
exhaust port
port of the medical equipment or device from which gas is discharged to the atmosphere during
normal use, either directly or via an anaesthetic gas scavenging system
[SOURCE: ISO 19223:2019, 3.14.2]
201.3.214
firecall
method established to provide emergency access to a secure medical device
Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the
problem. When a firecall is used, there is usually a review process to ensure that the access was used properly to
correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time
password or other suitable measures.
Note 2 to entry: Also referred to as "break glass" feature.
[SOURCE: IEC/TR 60601-4-5:2021, 3.11]
201.3.215
flow-direction-sensitive component
component or accessory through which gas flow is in one direction only for proper functioning or
patient safety
[SOURCE: ISO 4135:2022, 3.1.4.15, modified — added ‘or accessory’ and replaced “has to be” with “is”.]
201.3.216
gas intake port
port through which gas is drawn for use by the patient
Note 1 to entry: Gas is drawn at a sub-ambient pressure at a gas intake port, in opposition to an inlet, at which
gas is provided by a medical gas supply system.
[SOURCE: ISO 4135:2022, 3.1.4.21, modified — replaced “apposition” with ”opposition”.]
201.3.217
gas pathway
interior surfaces, over which gases or liquids that can be inspired pass
EXAMPLE 1 The ventilator breathing system, inlet filter, gas mixer, blower and internal piping.
EXAMPLE 2 Enclosed chamber of an incubator including the mattress or the inner surface of an oxygen hood.
EXAMPLE 3 The inner surfaces of breathing tubes, tracheal tubes or masks and mouthpieces.
Note 1 to entry: The gas pathway is bounded by the ports through which gases or liquids enter the medical
device. This can include the patient interface or the interior surfaces of enclosures that are in contact with gases
or liquids that can be inspired.
Note 2 to entry: The gas pathway can include some surfaces in the expiratory pathway.
ISO/FDIS 80601-2-67:2025(en)
Note 3 to entry: Patient contact surfaces such as the outer surfaces of a tracheal tube or the cushion of a mask
are evaluated according to the ISO 10993 series.
[SOURCE: ISO 18562-1:2024, 3.11]
201.3.218
high-pressure inlet
inlet to which gas is supplied at a pressure exceeding 100 kPa above ambient
Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts,
including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 600 kPa),
manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).
[SOURCE: ISO 4135:2022, 3.1.4.24]
201.3.219
home healthcare environment
dwelling place in which a patient lives or other places where patients are present, excluding
professional healthcare facility environments where operators with medical training are continually
available when patients are present
EXAMPLE In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical
centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms,
multiple treatment facilities and emergency medical services.
Note 2 to entry: Nursing homes are considered home healthcare environments.
Note 3 to entry: Other places where a patient is present include the outdoor environment, while working and in
vehicles.
[SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.1, modified — deleted “For the purpose of this
collateral standard,”.]
201.3.220
I:E ratio
ratio of the inspiratory time to the expiratory time in a respiratory cycle
[SOURCE: ISO 19223:2019, 3.4.19, modified — deleted notes.]
201.3.221
immunity
the ability of ME equipment or an ME system to perform without degradation in the presence of an
electromagnetic disturbance
[SOURCE: IEC 60601-1-2:2014+AMD1:2020, 3.8]
ISO/FDIS 80601-2-67:2025(en)
201.3.222
information supplied by the manufacturer
information related to the identification and use of a medical device or accessory, in whatever form
provided, intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the
manufacturer.
Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded
from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such
supplemental information as information supplied by the manufacturer.
Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical
device and its manufacturer, and provide essential information about its safety, performance, and appropriate
use to the user or other relevant persons.
[SOURCE: ISO 20417:2021, 3.10, modified — deleted note 4.]
201.3.223
inlet
opening through which gas or other material is pushed by an elevated upstream pressure
[SOURCE: ISO 4135:2022, 3.1.4.26, modified — deleted note.]
201.3.224
inspiratory time
t
I
duration of an inflation phase or inspiratory phase
[SOURCE: ISO 19223:2019, 3.4.8, modified — deleted notes.]
201.3.225
instructions for use
IFU
portion of the accompanying information that is essential for the safe and effective use of a medical
device or accessory directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with
relevant specialized training.
Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of
a medical device or accessory can be included in the instructions for use.
Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is
considered as appearing on the item.
Note 4 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or
accessory.
Note 5 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use
are exempted from having instructions for use by some authorities having jurisdiction.
ISO/FDIS 80601-2-67:2025(en)
[SOURCE: ISO 20417:2021, 3.11, modified — deleted note 6.]
201.3.226
lay
lay person
term referring to non-professional or professional without relevant specialized training
EXAMPLE Lay operator, lay responsible organization.
[SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.2]
201.3.227
low-pressure hose assembly
assembly consisting of a flexible hose with permanently attached gas-specific inlet and outlet
connectors and designed to conduct a medical gas at pressures less than 1 400 kPa
Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts,
including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 1 400
kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).
[SOURCE: ISO 4135:2022, 3.2.3.1]
201.3.228
lung
each of the pair of compliant organs within the ribcage (thorax), bounded by the terminal bronchiole
and the visceral pleura, which during ventilation provide gas/blood interfaces that enable oxygen from
the gas to pass into the blood and carbon dioxide to be removed
[SOURCE: ISO 19223:2019, 3.1.16, modified — deleted notes.]
201.3.229
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessory
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly
described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of
marking.
[SOURCE: ISO 20417:2021, 3.16, modified — deleted note 3.]
201.3.230
mask
device which provides a non-invasive interface between the patient’s airway and a patient-connection
port or other connection to a source of respirable gas
[SOURCE: ISO 4135:2022, 3.8.6.4]
ISO/FDIS 80601-2-67:2025(en)
201.3.231
maximum limited pressure
P
Lim,max
highest airway pressure that can occur during normal use or under single fault condition
[SOURCE: ISO 19223:2019, 3.13.3, modified — deleted notes.]
201.3.232
medical gas pipeline system
combination of a supply system, monitoring and alarm system and a pipeline distribution system with
terminal units for provision of medical gases or vacuum
[SOURCE: ISO 4135:2022, 3.2.1.1]
201.3.233
outlet
opening through which gas leaves a device or component
[SOURCE: ISO 4135:2022, 3.1.4.40]
201.3.234
processing
activity to prepare a new or used medical device and
accessory for its intended use
[SOURCE: ISO 20417:2021, 3.20]
201.3.235
security level
level corresponding to the required set of countermeasures and inherent cybersecurity properties of
devices and systems for a zone or conduit based on assessment of risk for the zone or conduit
[SOURCE: IEC/TR 60601-4-5:2021, 3.23]
201.3.236
set rate
number of assured inflations that are set to occur in a specified period of time, expressed as breaths
per minute
[SOURCE: ISO 19223:2019, 3.5.1.1, modified — deleted notes and examples.]
201.3.237
single use
intended by the manufacturer to be used on an individual patient or
specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further
processed and used again.
ISO/FDIS 80601-2-67:2025(en)
[SOURCE: ISO 20417:2021, 3.26]
201.3.238
standard temperature and pressure, dry
STPD
pressure of 101,325 kPa at a temperature of 20 °C, dry
[SOURCE: ISO 4135:2022, 3.1.1.8]
201.3.239
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
[SOURCE: ISO 17664-1:2021, 3.17]
201.3.240
symbol
graphical representation appearing on the label or associated documentation of a medical device that
communicates characteristic information without the need for the supplier or receiver of the
information to have knowledge of the language of a particular nation or people
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar
objects, including alphanumeric characters (with sufficient justification).
[SOURCE: ISO 20417:2021, 3.29]
201.3.241
technical description
portion of the accompanying information directed to the responsible organization and service personnel
that is essential for preparation for the first use and safe use, maintenance or repair as well as
processing transport or storage for the expected service life of a medical device
Note 1 to entry: The technical description may be included in the instructions for use.
[SOURCE: ISO 20417:2021, 3.30, modified — replaced 'expected lifetime' with 'expected service life'
and deleted note 2.]
201.3.242
tidal volume
V
T
volume of gas that enters and leaves the lung during a breath
[SOURCE: ISO 19223:2019, 3.8.1, modified — deleted notes.]
ISO/FDIS 80601-2-67:2025(en)
201.3.243
use specification
summary of the important characteristics related to the context of use of the medical device
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the use specification.
Note 2 to entry: The summary of the medical device use specification is referred to by some authorities having
jurisdiction as the ‘statement of intended use’.
Note 3 to entry: The use specification is an input to determining the intended use of ISO 14971:2019.
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.23]
201.3.244
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of
determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
[SOURCE: ISO 9000:2015, 3.8.13]
201.4 General requirements
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 4 applies, e
...
ISO/FDIS 80601-2-67:2024(Ed 32025(en)
Date : 2025-06-07
ISO TC 121/SC 3/
2025-05-19
Secretariat: ANSI
Medical electrical equipment — Part 2-67: Particular
requirements for basic safety and essential performance of
oxygen conserving equipment
Appareils électromédicaux — Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles dee économiseurs d'oxygène
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.
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
Ch. de Blandonnet 8 • CP 401
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
copyright@iso.org
www.iso.org
i
ISO/FDIS 80601-2-67:2024(en)
Contents Page
Foreword . iv
Introduction . vi
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 14
201.5 General requirements for testing of ME equipment . 16
201.6 Classification of ME equipment and ME systems . 17
201.7 ME equipment identification, marking and documents . 17
201.8 Protection against electrical hazards from ME equipment . 25
201.9 Protection against mechanical hazards of ME equipment and ME systems . 25
201.10 Protection against unwanted and excessive radiation hazards . 25
201.11 Protection against excessive temperatures and other hazards . 25
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 27
201.13 Hazardous situations and fault conditions . 31
201.14 Programmable electrical medical systems (PEMS) . 31
201.15 Construction of ME equipment . 31
201.16 ME systems . 32
201.17 Electromagnetic compatibility of ME equipment and ME systems. 32
201.101 Gas connections. 32
201.102 Requirements for parts and accessories . 33
201.103 Oxygen pressure regulators . 35
202 Electromagnetic disturbances – Requirements and tests . 35
202.4.3.1 Configurations . 35
206 Usability . 36
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 38
Annex D (informative) Symbols on marking . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) Reference to the IMDRF essential principles and labelling
guidances . 53
Annex CC (informative) Terminology — Alphabetized index of defined terms . 57
Bibliography . 60
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in
this Annex ZA . 65
iii
ISO/FDIS 80601-2-67:2024(en)
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).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
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 jointly 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, Medical equipment, software, and systems, Subcommittee SC D,
Particular medical equipment, software, and systems, 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 third edition cancels and replaces the second edition (ISO 80601-2-67:2020), which has been
technically revised.
The main changes are as follows:
— updated references, where appropriate;
— harmonization with ISO 20417, where appropriate;
— updated uncertainty of measurement requirements;
— added marking requirements for gas intake port, external gas sources and MR compatibility;
iv
ISO/FDIS 80601-2-67:2024(en)
— requirements for processing of the enclosure;
— added cybersecurity recommendations; and
— updated connector requirements.
A list of all parts in the ISO 80601 and 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.
v
ISO/FDIS 80601-2-67:2024(en)
Introduction
Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and
oxygen from an oxygen concentrator.
Most clinicians prescribe low flow oxygen therapy as continuous flow oxygen (CFO) delivery in l/min.
CFO systems deliver the flow of oxygen without regard for the patient’s breathing rate or pattern.
Outside of the institutional care setting, the provision of CFO therapy is often a significant expense and
can limit the mobility of a patient to the immediate vicinity of a stationary or fixed oxygen delivery
system. To support mobility, patients use CFO from portable liquid or compressed oxygen systems with
a limited storage capacity that can limit a patient’s time and activities while away from a stationary
oxygen supply.
Conserving equipment that delivers supplemental oxygen as a bolus conserves usage while allowing
satisfactory patient arterial oxygen saturation (SaO ) to be maintained during daily activities.
Conserving equipment delivers supplemental oxygen unlike CFO in that the therapy gas flow is delivered
only during the inspiratory phase of the breathing cycle, when it is most likely to reach the alveoli.
During both the expiratory and pause phase of the breathing cycle, the flow of supplemental oxygen is
stopped, minimizing waste. Because flow over time produces a volume, the bolus delivered by the
conserving equipment is typically represented as a volume of gas. Therapy using conserving equipment
versus CFO results in lower operating costs and longer ambulatory times for patients using the same
CFO storage capacity.
Operation of conserving equipment from various manufacturers can differ in the dose delivery
mechanism resulting in variations in oxygen therapy to the patient. The use of CFO numerical markings
for dose settings on conserving equipment can not directly correlate with CFO settings and can lead to
misinterpretation of gas delivery rates and volumes for a particular patient. This can result in incorrect
patient setup and therapy delivery over all breathing rates and patterns versus CFO. Because of the
differences in delivery, settings, and markings versus CFO therapy, conserving equipment use has
requirements for patient titration to determine the proper setting(s) needed to provide adequate SaO
levels for the patient breathing patterns.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in Clause 3 of the general standard, in this particular document or as noted: italic type;
and
— informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
In referring to the structure of this document, the term.
— “clause” means one of the three numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 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 particular document are by number only.
vi
ISO/FDIS 80601-2-67:2024(en)
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 requirement or a test is 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.
vii
ISO/FDIS 80601-2-67:2024(en)
ii
FINAL DRAFT INTERNATIONAL ISO/FDIS 80601-2-67:20242025(en)
STANDARDInternational Standard
Medical electrical equipment —
Part 2-67:
Particular requirements for basic safety and essential
performance of oxygen conserving equipment
201.1 Scope, object and related standards
NOTE 1 There is guidance or rationale for this clause contained in Clause AA.2.1.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE 2 The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:
This document is applicable to the basic safety and essential performance of oxygen conserving
equipment, hereafter referred to as ME equipment, in combination with its accessories intended to
conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's
inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is
typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
[4][4] [12][12]
EXAMPLE Conserving equipment combined with a pressure regulator , an oxygen concentrator or
[7][7]
liquid oxygen equipment .
This document is also applicable to those accessories intended by their manufacturer to be connected
to conserving equipment, where the characteristics of those accessories can affect the basic safety or
essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment
models, as well as between the operation of conserving equipment and continuous flow oxygen
equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is
not applicable to non-active devices (e.g. reservoir cannulas).
ISO/FDIS 80601-2-67:2024(en)
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 in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
201.1.2 Object
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance
requirements for conserving equipment [as defined in 201.3.207] and its accessories.
NOTE 1 Accessories are included because accessories can have a significant impact on the basic safety or
essential performance of conserving equipment.
[17]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
[18]
principles guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in
Annex BB.
NOTE 3 This document has been prepared to address the relevant general safety and performance
[16][16]
requirements of European regulation (EU) 2017/745 .
201.1.3 Collateral standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:
IEC 60601-1-2+AMD1:2020 and IEC 60601-1-6+AMD1:2013+AMD2:2020 apply as modified in
Clauses 202 and 206 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards define basic safety and essential performance
requirements, and may modify, replace or delete requirements contained in the general standard and
collateral standards as appropriate for the particular ME equipment under consideration.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1+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 that 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 “20x”, where x is the final digit(s) of the
collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 206.4 in this document addresses the content of Clause 4 of the
ISO/FDIS 80601-2-67:2025(en)
IEC 60601-1-6 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 the general standard or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general
standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which 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, figures or tables which 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, 206
for IEC 60601-1-6, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the
general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or 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.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Addition:
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 5359:2014+AMD1:2017, Low-pressure hose assemblies for use with medical gases
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
ISO/FDIS 80601-2-67:2024(en)
ISO 10524-3:2019, Pressure regulators for use with medical gases — Part 3: Pressure regulators
integrated with cylinder valves (VIPRs)
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 18562-1:2024, 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 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in
the electrotechnical sector
EN 13544-2:2002+AMD1:2009, Respiratory therapy equipment — Part 2: Tubing and connectors
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 http://www.electropedia.org/
NOTE An alphabetized index of defined terms is found in Annex CC.
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
Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2024.
ISO/FDIS 80601-2-67:2025(en)
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 can 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 — replaced "could" with "can" and deleted note 4.]
201.3.202
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]
201.3.203
attack
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized
use of an asset
[SOURCE: IEC 81001-5-1:2021, 3.5]
201.3.204
biocompatibility
ability of a medical device, accessory or material to perform with an appropriate host response in a
specific application
Note 1 to entry: A medical device or accessory may produce some level of adverse effect, but that level may be
determined to be acceptable when considering the benefits provided by the medical device or accessory.
[SOURCE: ISO 18562-1:2024, 3.6]
201.3.205
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other
debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated
process that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2021, 3.1, modified — replaced 'and/or' with 'or'.]
201.3.206
connector
fitting to join two or more components
ISO/FDIS 80601-2-67:2024(en)
EXAMPLE Connectors for low-pressure hose assembly are any of a range of mating components intended to
maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each
particular gas.
[SOURCE: ISO 4135:2022, 3.1.4.5]
201.3.207
conserving equipment
ME equipment intended to conserve supplemental oxygen by delivering gas intermittently and
synchronized with the patient's inspiratory cycle
Note 1 to entry: Conserving equipment can be electrically or pneumatically powered.
201.3.208
conserving equipment with monitoring function
conserving equipment suitable for use with patients where monitoring of oxygen delivery via the
conserving equipment is indicated
201.3.209
cybersecurity
state where information and systems are protected from unauthorized activities, such as access, use,
disclosure, disruption, modification, or destruction to a degree that the related risks to violation of
confidentiality, integrity, and availability are maintained at an acceptable level throughout the life
cycle
[SOURCE: IEC 81001-5-1:2021, 3.30]
201.3.210
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 17664-2:2021, 3.5]
201.3.211
essential function
function or capability that is required to maintain basic safety, essential performance, a minimum of
clinical functionality as specified by the manufacturer, and operational availability for the medical
device
Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety
and essential performance), the control function and the availability of urgently needed functions and such
allowing the operator to view and manipulate the medical device safely with the most urgently needed
performance (operational availability). The loss of essential function is commonly termed loss of protection, loss
of control and loss of view respectively.
Note 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose and
scope of this document.
ISO/FDIS 80601-2-67:2025(en)
[SOURCE: IEC/TR 60601-4-5:2021, 3.10]
201.3.212
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a medical device is safe and
performs as intended
[SOURCE: ISO 16142-1:2016, 3.3]
201.3.213
exhaust port
port of the medical equipment or device from which gas is discharged to the atmosphere during
normal use, either directly or via an anaesthetic gas scavenging system
[SOURCE: ISO 19223:2019, 3.14.2]
201.3.214
firecall
method established to provide emergency access to a secure medical device
Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the
problem. When a firecall is used, there is usually a review process to ensure that the access was used properly to
correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time
password or other suitable measures.
Note 2 to entry: Also referred to as "break glass" feature.
[SOURCE: IEC/TR 60601-4-5:2021, 3.11]
201.3.215
flow-direction-sensitive component
component or accessory through which gas flow is in one direction only for proper functioning or
patient safety
[SOURCE: ISO 4135:2022, 3.1.4.15, modified — added ‘or accessory’ and replaced “has to be” with “is”.]
201.3.216
gas intake port
port through which gas is drawn for use by the patient
Note 1 to entry: Gas is drawn at a sub-ambient pressure at a gas intake port, in opposition to an inlet, at which
gas is provided by a medical gas supply system.
[SOURCE: ISO 4135:2022, 3.1.4.21, modified — replaced “apposition” with ”opposition”.]
ISO/FDIS 80601-2-67:2024(en)
201.3.217
gas pathway
interior surfaces, over which gases or liquids that can be inspired pass
EXAMPLE 1 The ventilator breathing system, inlet filter, gas mixer, blower and internal piping.
EXAMPLE 2 Enclosed chamber of an incubator including the mattress or the inner surface of an oxygen hood.
EXAMPLE 3 The inner surfaces of breathing tubes, tracheal tubes or masks and mouthpieces.
Note 1 to entry: The gas pathway is bounded by the ports through which gases or liquids enter the medical
device. This can include the patient interface or the interior surfaces of enclosures that are in contact with gases
or liquids that can be inspired.
Note 2 to entry: The gas pathway can include some surfaces in the expiratory pathway.
Note 3 to entry: Patient contact surfaces such as the outer surfaces of a tracheal tube or the cushion of a mask
are evaluated according to the ISO 10993 series.
[SOURCE: ISO 18562-1:2024, 3.11]
201.3.218
high-pressure inlet
inlet to which gas is supplied at a pressure exceeding 100 kPa above ambient
Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts,
including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 600 kPa),
manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).
[SOURCE: ISO 4135:2022, 3.1.4.24]
201.3.219
home healthcare environment
dwelling place in which a patient lives or other places where patients are present, excluding
professional healthcare facility environments where operators with medical training are continually
available when patients are present
EXAMPLE In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical
centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms,
multiple treatment facilities and emergency medical services.
Note 2 to entry: Nursing homes are considered home healthcare environments.
Note 3 to entry: Other places where a patient is present include the outdoor environment, while working and in
vehicles.
[SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.1, modified — deleted “For the purpose of this
collateral standard,”.]
ISO/FDIS 80601-2-67:2025(en)
201.3.220
I:E ratio
ratio of the inspiratory time to the expiratory time in a respiratory cycle
[SOURCE: ISO 19223:2019, 3.4.19, modified — deleted notes.]
201.3.221
immunity
the ability of ME equipment or an ME system to perform without degradation in the presence of an
electromagnetic disturbance
[SOURCE: IEC 60601-1-2:2014+AMD1:2020, 3.8]
201.3.222
information supplied by the manufacturer
information related to the identification and use of a medical device or accessory, in whatever form
provided, intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the
manufacturer.
Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded
from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such
supplemental information as information supplied by the manufacturer.
Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical
device and its manufacturer, and provide essential information about its safety, performance, and appropriate
use to the user or other relevant persons.
[SOURCE: ISO 20417:2021, 3.10, modified — deleted note 4.]
201.3.223
inlet
opening through which gas or other material is pushed by an elevated upstream pressure
[SOURCE: ISO 4135:2022, 3.1.4.26, modified — deleted note.]
201.3.224
inspiratory time
t
I
duration of an inflation phase or inspiratory phase
[SOURCE: ISO 19223:2019, 3.4.8, modified — deleted notes.]
ISO/FDIS 80601-2-67:2024(en)
201.3.225
instructions for use
IFU
portion of the accompanying information that is essential for the safe and effective use of a medical
device or accessory directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with
relevant specialized training.
Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of
a medical device or accessory can be included in the instructions for use.
Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is
considered as appearing on the item.
Note 4 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or
accessory.
Note 5 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use
are exempted from having instructions for use by some authorities having jurisdiction.
[SOURCE: ISO 20417:2021, 3.11, modified — deleted note 6.]
201.3.226
lay
lay person
term referring to non-professional or professional without relevant specialized training
EXAMPLE Lay operator, lay responsible organization.
[SOURCE: IEC 60601-1-11:2015+AMD1:2020, 3.2]
201.3.227
low-pressure hose assembly
assembly consisting of a flexible hose with permanently attached gas-specific inlet and outlet
connectors and designed to conduct a medical gas at pressures less than 1 400 kPa
Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts,
including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 1 400
kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).
[SOURCE: ISO 4135:2022, 3.2.3.1]
201.3.228
lung
each of the pair of compliant organs within the ribcage (thorax), bounded by the terminal bronchiole
and the visceral pleura, which during ventilation provide gas/blood interfaces that enable oxygen from
the gas to pass into the blood and carbon dioxide to be removed
[SOURCE: ISO 19223:2019, 3.1.16, modified — deleted notes.]
ISO/FDIS 80601-2-67:2025(en)
201.3.229
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessory
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly
described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of
marking.
[SOURCE: ISO 20417:2021, 3.16, modified — deleted note 3.]
201.3.230
mask
device which provides a non-invasive interface between the patient’s airway and a patient-connection
port or other connection to a source of respirable gas
[SOURCE: ISO 4135:2022, 3.8.6.4]
201.3.231
maximum limited pressure
P
Lim,max
highest airway pressure that can occur during normal use or under single fault condition
[SOURCE: ISO 19223:2019, 3.13.3, modified — deleted notes.]
201.3.232
medical gas pipeline system
combination of a supply system, monitoring and alarm system and a pipeline distribution system with
terminal units for provision of medical gases or vacuum
[SOURCE: ISO 4135:2022, 3.2.1.1]
201.3.233
outlet
opening through which gas leaves a device or component
[SOURCE: ISO 4135:2022, 3.1.4.40]
201.3.234
processing
activity to prepare a new or used medical device and
accessory for its intended use
[SOURCE: ISO 20417:2021, 3.20]
ISO/FDIS 80601-2-67:2024(en)
201.3.235
security level
level corresponding to the required set of countermeasures and inherent cybersecurity properties of
devices and systems for a zone or conduit based on assessment of risk for the zone or conduit
[SOURCE: IEC/TR 60601-4-5:2021, 3.23]
201.3.236
set rate
number of assured inflations that are set to occur in a specified period of time, expressed as breaths
per minute
[SOURCE: ISO 19223:2019, 3.5.1.1, modified — deleted notes and examples.]
201.3.237
single use
intended by the manufacturer to be used on an individual patient or
specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further
processed and used again.
[SOURCE: ISO 20417:2021, 3.26]
201.3.238
standard temperature and pressure, dry
STPD
pressure of 101,325 kPa at a temperature of 20 °C, dry
[SOURCE: ISO 4135:2022, 3.1.1.8]
201.3.239
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
[SOURCE: ISO 17664-1:2021, 3.17]
201.3.240
symbol
graphical representation appearing on the label or associated documentation of a medical device that
communicates characteristic information without the need for the supplier or receiver of the
information to have knowledge of the language of a particular nation or people
ISO/FDIS 80601-2-67:2025(en)
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar
objects, including alphanumeric characters (with sufficient justification).
[SOURCE: ISO 20417:2021, 3.29]
201.3.241
technical description
portion of the accompanying information directed to the responsible organization and service personnel
that is essential for preparation for the first use and safe use, maintenance or repair as well as
processing transport or storage for the expected service life of a medical device
Note 1 to entry: The technical description may be included in the instructions for use.
[SOURCE: ISO 20417:2021, 3.30, modified — replaced 'expected lifetime' with 'expected service life'
and deleted note 2.]
201.3.242
tidal volume
V
T
volume of gas that enters and leaves the lung during a breath
[SOURCE: ISO 19223:2019, 3.8.1, modified — deleted notes.]
201.3.243
use specification
summary of the important characteristics related to the context of use of the medical device
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the use specification.
Note 2 to entry: The summary of the medical device use specification is referred to by some authorities having
jurisdiction as the ‘statement of intended use’.
Note 3 to entry: The use specification is an input to determining the intended use of ISO 14971:2019.
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.23]
201.3.244
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of
determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
ISO/FDIS 80601-2-67:2024(en)
[SOURCE: ISO 9000:2015, 3.8.13]
201.4 General requirements
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 4 applies, except as follows:
201.4.3 Essential performance
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.3 applies, except as follows:
Additional subclause:
201.4.3.101 Additional requirements for essential performance
NOTE There is guidance or rationale for this subclause contained in Clause AA.2.2.
Additional essential performance requirements are found in the subclauses listed in Table 201.101.
Table 201.101 — Distributed essential performance requirements
Requirement Subclause
For conserving equipment with monitoring
...
PROJET FINAL
Norme
internationale
ISO/FDIS
80601-2-67
ISO/TC 121/SC 3
Appareils électromédicaux —
Secrétariat: ANSI
Partie 2-67:
Début de vote:
2025-10-07
Exigences particulières pour la
sécurité de base et les performances
Vote clos le:
2025-12-02
essentielles des économiseurs
d'oxygène
Medical electrical equipment —
Part 2-67: Particular requirements for basic safety and essential
performance of oxygen-conserving equipment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
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PROJETS DE NORMES
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Numéro de référence
ISO/FDIS 80601-2-67:2025(fr) © ISO 2025
PROJET FINAL
ISO/FDIS 80601-2-67:2025(fr)
Norme
internationale
ISO/FDIS
80601-2-67
ISO/TC 121/SC 3
Appareils électromédicaux —
Secrétariat: ANSI
Partie 2-67:
Début de vote:
Exigences particulières pour la 2025-10-07
sécurité de base et les performances
Vote clos le:
2025-12-02
essentielles des économiseurs
d'oxygène
Medical electrical equipment —
Part 2-67: Particular requirements for basic safety and essential
performance of oxygen-conserving equipment
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
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ii
ISO/FDIS 80601-2-67:2025(fr)
Sommaire Page
Avant-propos . v
Introduction . vii
201. 1 Domaine d'application, objet et normes connexes . 1
201. 2 Références normatives . 3
201. 3 Termes et définitions . 4
201. 4 Exigences générales . 14
201. 5 Exigences générales relatives aux essais des appareils EM . 17
201. 6 Classification des appareils EM et des systèmes EM . 19
201. 7 Identification, marquage et documentation des appareils EM . 19
201. 8 Protection contre les dangers d'origine électrique provenant des appareils EM . 27
201. 9 Protection contre les dangers mécaniques des appareils EM et systèmes EM . 27
201. 10 Protection contre les dangers dus aux rayonnements involontaires ou excessifs . 27
201. 11 Protection contre les températures excessives et autres dangers . 27
201. 12 Précision des commandes et des instruments et protection contre les
caractéristiques de sortie dangereuses . 29
201. 13 Situations dangereuses et conditions de défaut . 33
201. 14 Systèmes électromédicaux programmables (SEMP) . 33
201. 15 Construction de l'appareil EM . 34
201. 16 Systèmes EM . 34
201. 17 Compatibilité électromagnétique des appareils EM et des systèmes EM . 35
201.101 Raccordements des gaz . 35
201.102 Exigences applicables aux parties et accessoires . 36
201.103 Détendeurs d'oxygène . 37
202 Perturbations électromagnétiques — Exigences et essais . 38
202.4.3.1 Configurations . 38
206 Aptitude à l'utilisation . 39
Annexe C (informative) Guide pour les exigences de marquage et d'étiquetage pour les
appareils EM et systèmes EM . 40
Annexe D (informative) Symboles de marquage . 45
Annexe AA (informative) Recommandations particulières et justifications . 46
Annexe BB (informative) Référence aux principes essentiels et aux recommandations
d'étiquetage de l'IMDRF . 56
iii
ISO/FDIS 80601-2-67:2025(fr)
Annexe CC (informative) Terminologie — Index alphabétique des termes définis . 60
Bibliographie . 70
iv
ISO/FDIS 80601-2-67:2025(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) et l'IEC (Commission électrotechnique internationale)
forment le système spécialisé de la normalisation mondiale. Les organismes nationaux membres de l'ISO ou
de l'IEC participent au développement de Normes Internationales par l'intermédiaire des comités
techniques créés par l'organisation concernée afin de s'occuper des domaines particuliers de l'activité
technique. Les comités techniques de l'ISO et de l'IEC collaborent dans des domaines d'intérêt commun.
D'autres organisations internationales, gouvernementales et non gouvernementales, en liaison avec l'ISO et
l'IEC participent également aux travaux.
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. 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'ISO et l'IEC attirent l'attention sur le fait que la mise en application du présent document peut entraîner
l'utilisation d'un ou de plusieurs brevets. L'ISO et L'IEC ne prennent pas position quant à la preuve, à la
validité et à l'applicabilité de tout droit de propriété revendiqué à cet égard. À la date de publication du
présent document, l'ISO et l'IEC n'avaient pas reçu notification qu'un ou plusieurs brevets pouvaient être
nécessaires à sa mise en application. Toutefois, il y a lieu d'avertir les responsables de la mise en application
du présent document que des informations plus récentes sont susceptibles de figurer dans la base de
données de brevets, disponible à l'adresse www.iso.org/brevets et https://patents.iec.ch. L'ISO et l'IEC ne
sauraient être tenues pour responsables de ne pas avoir identifié tout ou partie de tels droits de brevet.
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/avant-propos. Pour l'IEC, voir www.iec.ch/understanding-standards.
Le présent document a été élaboré conjointement par le comité technique 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, Appareils, logiciels et systèmes médicaux, sous-comité
SC D, Appareils, logiciels et systèmes médicaux particuliers, 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 troisième édition annule et remplace la deuxième édition (ISO 80601-2-67:2020), qui a fait l'objet
d'une révision technique.
Les principales modifications sont les suivantes :
— mise à jour des références, le cas échéant ;
— harmonisation avec l'ISO 20417, le cas échéant ;
— mise à jour des exigences d'incertitude de mesure ;
v
ISO/FDIS 80601-2-67:2025(fr)
— ajout des exigences de marquage pour l'orifice d'aspiration du gaz, les sources de gaz externes et la
compatibilité RM ;
— exigences relatives au traitement de l'enveloppe ;
— ajout des recommandations en matière de cybersécurité ; et
— mise à jour des exigences en matière de raccord.
Une liste de toutes les parties de la série ISO 80601 et IEC 80601 se trouve sur les sites web de l'ISO et de
l'IEC.
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 aux adresses www.iso.org/fr/members.html et www.iec.ch/national-committees.
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ISO/FDIS 80601-2-67:2025(fr)
Introduction
Des essais cliniques randomisés contrôlés ont démontré que l'oxygénothérapie à long terme prolongeait la
survie des patients atteints d'une maladie respiratoire chronique avec une hypoxémie établie. Les sources
habituelles d'oxygénothérapie thérapeutique à long terme comprennent l'oxygène gazeux provenant de
bouteilles ou d'oxygène liquide et l'oxygène provenant d'un concentrateur d'oxygène.
La plupart des cliniciens spécifient une oxygénothérapie à faible débit en tant qu'oxygénothérapie à débit
continu en l/min. Les systèmes d'oxygénothérapie à débit continu fournissent le débit d'oxygène
indépendamment de la fréquence et du modèle respiratoire du patient. En dehors du cadre de soins
institutionnel, l'oxygénothérapie à débit continu constitue souvent une dépense importante et peut
restreindre la mobilité d'un patient aux environs immédiats d'un système de fourniture d'oxygène fixe ou
stationnaire. Afin de favoriser la mobilité, les patients utilisent l'oxygène à débit continu provenant de
systèmes d'oxygène liquide ou comprimé portables ayant une capacité de stockage limitée qui peuvent
restreindre les activités et le temps d'un patient lorsque celui-ci ne se trouve pas à proximité d'un dispositif
de fourniture d'oxygène stationnaire.
Un économiseur qui délivre un supplément d'oxygène sous la forme d'un bolus conserve son usage tout en
permettant le maintien d'une saturation satisfaisante du sang artériel en oxygène (SaO ) du patient lors des
activités quotidiennes. Un économiseur délivre un supplément d'oxygène différemment de l'oxygénothérapie
à débit continu, en ce sens que l'écoulement de gaz thérapeutique n'est fourni que pendant la phase
d'inspiration du cycle respiratoire, lorsqu'il est le plus susceptible d'atteindre les alvéoles. Au cours des
phases d'expiration et de pause du cycle respiratoire, l'écoulement du supplément d'oxygène est stoppé,
réduisant ainsi au minimum les pertes. Étant donné que l'écoulement produit au fil du temps un volume, le
bolus fourni par l'économiseur est habituellement représenté comme un volume de gaz. En comparaison
avec l'oxygénothérapie à débit continu, la thérapie utilisant un économiseur permet des coûts d'exploitation
plus faibles et des durées ambulatoires plus longues pour des patients utilisant la même capacité de stockage
d'oxygène à débit continu.
Le fonctionnement d'un économiseur peut être différent selon les fabricants en ce qui concerne le mécanisme
de fourniture de dose, ce qui peut causer des variations dans l'oxygénothérapie du patient. L'utilisation de
marquages numériques d'oxygène à débit continu pour les dosages sur les économiseurs peut ne pas être
directement corrélée avec les réglages d'oxygène à débit continu et peut conduire à une mauvaise
interprétation des débits de fourniture de gaz et des volumes pour un patient particulier. Cela peut mener à
un réglage incorrect et à une mauvaise thérapie pour le patient pour tous les modèles et fréquences
respiratoires, par rapport à l'oxygénothérapie à débit continu. En raison des différences en matière de
fourniture, réglages et marquages par rapport à l'oxygénothérapie à débit continu, l'utilisation d'un
économiseur est soumise à des exigences pour la titration du patient afin de déterminer le ou les réglages
appropriés nécessaires et de fournir des niveaux de SaO adaptés aux modèles respiratoires du patient.
Dans le présent document, les polices et caractères suivants sont employés :
— exigences et définitions : caractères romains ;
— termes définis à l'Article 3 de la norme générale, dans le présent document ou en note : caractères
italiques ; et
— indications de nature informative apparaissant hors des tableaux, telles que les notes, exemples et
références : petits caractères. Le texte normatif à l'intérieur des tableaux est également en petits caractères.
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ISO/FDIS 80601-2-67:2025(fr)
Concernant la structure du présent document, le terme :
— « article » désigne l'une des trois sections numérotées dans le sommaire, avec toutes ses subdivisions
(par exemple l'Article 201 inclut les paragraphes 201.7, 201.8, etc.) ; et
— « paragraphe » désigne une subdivision numérotée d'un article (par exemple 201.7, 201.8 et 201.9 sont
tous des paragraphes appartenant à l'Article 201).
Dans le présent document, les références à des articles sont précédées du terme « Article » suivi du numéro
de l'article concerné. Dans le présent document, les références aux paragraphes utilisent uniquement le
numéro du paragraphe concerné.
Dans le présent document, la conjonction « ou » est utilisée comme un « ou inclusif » ; une affirmation est
donc vraie si une combinaison quelconque des conditions est vraie.
Pour les besoins du présent document :
— « doit » (« shall ») exprime une exigence ;
— « il convient » indique qu'une exigence ou un essai est une recommandation ;
— « peut » (« may ») exprime une permission ;
— « peut » (« can ») est utilisé pour décrire une possibilité ou une capacité ; et
— « doit » (« must ») est utilisé pour exprimer une contrainte externe.
L'Annexe C contient un guide pour le marquage et les exigences d'étiquetage dans le présent document.
L'Annexe D contient un résumé des symboles référencés dans le présent document.
Les exigences du présent document ont été divisées de manière à ce que chacune d'entre elles soit délimitée
individuellement. Cela permet de prendre en charge le suivi automatisé des exigences.
viii
PROJET FINAL de Norme internationale ISO/FDIS 80601-2-67:2025(fr)
Appareils électromédicaux —
Partie 2-67 :
Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
201.1 Domaine d'application, objet et normes connexes
NOTE 1 L'Article AA.2.1 contient des recommandations ou justifications concernant le présent article.
L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, Article 1, s'applique, avec les exceptions suivantes :
NOTE 2 La norme générale est l'IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Domaine d'application
L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 est remplacé par :
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur
d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser
le supplément d'oxygène en délivrant du gaz de manière intermittente et synchronisée en suivant le cycle
d'inspiration du patient, pour une utilisation dans l'environnement de soins à domicile. L'économiseur
d'oxygène est habituellement utilisé par un opérateur non spécialiste.
NOTE 1 Un économiseur peut également être utilisé dans des établissements de santé.
Le présent document s'applique également aux économiseurs intégrés à d'autres appareils.
Error! Reference source not found. Error! Reference
EXEMPLE Économiseur associé à un détendeur , un concentrateur d'oxygène
source not found. Error! Reference source not found.
ou un appareil à oxygène liquide .
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un
économiseur, du fait que les caractéristiques de ces accessoires peuvent avoir une incidence sur la sécurité de
base ou sur les performances essentielles de l'économiseur.
Le présent document vise à préciser les différences de fonctionnement entre différents modèles
d'économiseurs, ainsi que les différences de fonctionnement entre économiseurs et appareils à oxygène à
débit continu, en exigeant des essais de performance et un étiquetage normalisés.
Le présent document ne s'applique qu'aux dispositifs actifs (par exemple, dotés d'une alimentation
pneumatique ou électrique) et ne s'applique pas aux dispositifs non actifs (par exemple, canules de
réservoir).
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou
uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas
le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
ISO/FDIS 80601-2-67:2025(fr)
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
contenues dans le présent document, à l'exception de l'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13
et 8.4.1.
NOTE 2 Des informations supplémentaires peuvent être trouvées dans
l'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
201.1.2 Objet
L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 est remplacé par :
Le présent document est destiné à spécifier des exigences particulières concernant la sécurité de base et les
performances essentielles applicables aux économiseurs (comme défini en 201.3.207) et à leurs accessoires.
NOTE 1 Les accessoires sont inclus du fait qu'ils peuvent avoir un impact significatif sur la sécurité de base ou sur les
performances essentielles d'un économiseur.
Error! Reference source not found.
NOTE 2 Le présent document a été élaboré pour satisfaire aux principes essentiels pertinents
Error! Reference source not found.
et aux recommandations relatives aux principes d'étiquetage de l'International Medical Devices
Regulators Forum (IMDRF), comme indiqué à l'Annexe BB.
NOTE 3 Le présent document a été élaboré pour satisfaire aux exigences générales en matière de sécurité et de
Error! Reference source not found.
performances pertinentes du Règlement de l'Union européenne (UE) 2017/745 .
201.1.3 Normes collatérales
L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 s'applique avec l'ajout suivant :
L'IEC 60601-1-2+AMD1:2020 et l'IEC 60601-1-6+AMD1:2013+AMD2:2020 s'appliquent telles que modifiées
dans les Articles 202 et 206, respectivement. L'IEC 60601-1-3 et l'IEC 60601‑1‑9 ne s'appliquent pas. Toutes
les autres normes collatérales publiées dans la série IEC 60601-1 s'appliquent telles que publiées.
201.1.4 Normes particulières
Remplacement :
Dans la série IEC 60601, des normes particulières définissent les exigences relatives à la sécurité de base et
aux performances essentielles, et peuvent modifier, remplacer ou supprimer des exigences contenues dans la
norme générale et les normes collatérales, selon ce qui est approprié pour l'appareil EM particulier
considéré.
Une exigence d'une norme particulière prévaut sur l'exigence correspondante de la norme générale.
Par souci de concision, le présent document fait référence à l'IEC 60601-1+AMD1:2012+AMD2:2020 comme
norme générale. Les normes collatérales sont désignées 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, dans le présent document, 201.1 reprend le contenu de
l'Article 1 de la norme générale) ou de la norme collatérale applicable avec le préfixe « 20x », où x est le(s)
dernier(s) chiffre(s) du numéro de document de la norme collatérale (par exemple, dans le présent
ISO/FDIS 80601-2-67:2025(fr)
document, 202.4 reprend le contenu de l'Article 4 de la norme collatérale IEC 60601-1-2, 206.4 reprend le
contenu de l'Article 4 de la norme collatérale IEC 60601-1-6, etc.). Les changements apportés au texte de la
norme générale sont spécifiés en utilisant les termes suivants :
« Remplacement » signifie que l'article ou le paragraphe de la norme générale ou de la norme collatérale
applicable est remplacé totalement par le texte du présent document.
« Ajout » signifie que le texte du présent document s'ajoute aux exigences de la norme générale ou de la
norme collatérale applicable.
« Modification » signifie que l'article ou le paragraphe de la norme générale ou de la norme collatérale
applicable est modifié comme cela est indiqué par le texte du présent document.
Les paragraphes, figures ou tableaux qui s'ajoutent à ceux de la norme générale sont numérotés à partir de
201.101. Toutefois, compte tenu du fait que les définitions de la norme générale sont numérotées de 3.1 à
3.154, les définitions qui s'ajoutent dans le présent document sont numérotées à partir de 201.3.201. Les
lettres AA, BB, etc., et aa), bb), etc., sont respectivement attribuées aux annexes et éléments supplémentaires.
Les paragraphes, figures ou tableaux qui s'ajoutent à ceux d'une norme collatérale sont numérotés à partir
de 20x, où « x » désigne le numéro de la norme collatérale, par exemple 202 pour IEC 60601-1-2, 206 pour
l'IEC 60601-1-6, etc.
Le terme « le présent document » permet de faire référence en même temps à la norme générale, aux normes
collatérales applicables et au présent document particulier.
Lorsqu'il n'existe aucun article ni aucun paragraphe correspondant dans le présent document, l'article ou le
paragraphe de la norme générale ou de la norme collatérale applicable, même éventuellement sans intérêt,
s'applique sans modification. Lorsqu'il est envisagé que toute partie de la norme générale ou de la norme
collatérale applicable, bien qu'éventuellement intéressante, ne doit pas être appliquée, une indication est
donnée à cet effet 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).
L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, Article 2, s'applique, avec les exceptions suivantes :
Ajout :
ISO 32:1977, Bouteilles à gaz pour usages médicaux — Marquage pour l'identification du contenu
ISO 5359:2014+AMD1:2017, Matériel d'anesthésie et de réanimation respiratoire — Flexibles de
raccordement à basse pression pour utilisation avec les gaz médicaux
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/FDIS 80601-2-67:2025(fr)
ISO 10524-1:2018, Détendeurs pour l'utilisation avec les gaz médicaux — Partie 1 : Détendeurs et détendeurs-
débitmètres
ISO 10524-3:2019, Détendeurs pour l'utilisation avec les gaz médicaux — Partie 3 : Détendeurs intégrés dans
les robinets des bouteilles à gaz (VIPR)
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 18562-1:2024, Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine
de la 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 80369-1:— , Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 1 : Exigences générales
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Appareils électromédicaux — Partie 1 : Exigences générales
pour la sécurité de base et les performances essentielles
IEC Guide 115:2023, Application de l'incertitude de mesure aux activités d'évaluation de la conformité dans le
secteur électrotechnique
EN 13544-2:2002+AMD1:2009, Équipement de thérapie respiratoire — Partie 2 : Tubes et raccords
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 Online browsing platform : disponible à l'adresse https://www.iso.org/obp
— IEC Electropedia : disponible à l'adresse https://www.electropedia.org/
NOTE Un index alphabétique des termes définis est disponible à l'Annexe CC.
En cours d'élaboration. Stade à la date de publication : ISO/FDIS 80369-1:2024.
ISO/FDIS 80601-2-67:2025(fr)
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, mais peuvent
comprendre des supports sonores, visuels ou tactiles et des médias multiples (par exemple : CD/DVD-ROM, clé USB,
site Internet).
[SOURCE : ISO 20417:2021, 3.2, modifié — « pourrait » remplacé par « peut » et note 4 supprimée.]
201.3.202
limite d'alarme
seuil utilisé par un système d'alarme pour déterminer une condition d'alarme
[SOURCE : IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
201.3.203
attaque
tentative de détruire, de rendre public, de modifier, d'invalider, de voler ou d'utiliser sans autorisation un
actif, ou de faire un usage non autorisé de celui-ci
[SOURCE : IEC 81001-5-1:2021, 3.5]
201.3.204
biocompatibilité
capacité d'un dispositif médical, d'un accessoire ou d'un matériau à produire une réponse hôte appropriée
dans une application spécifique
Note 1 à l'article : Un dispositif médical ou un accessoire peut produire un certain niveau d'effet indésirable, mais ce
niveau peut être considéré comme acceptable au vu des bénéfices fournis par le dispositif médical ou l'accessoire.
[SOURCE : ISO 18562-1:2024, 3.6]
201.3.205
nettoyage
élimination des contaminants jusqu'à obtention de l'état nécessaire à la poursuite du traitement ou jusqu'à
obtention de l'état désiré
ISO/FDIS 80601-2-67:2025(fr)
Note 1 à l'article : Le nettoyage consiste à éliminer les souillures adhérentes (par exemple, sang, substances protéiques
et autres débris) des surfaces, fentes, cannelures, joints et lumières d'un dispositif médical, par le biais d'un procédé
manuel ou automatique qui prépare les articles à une manipulation en toute sécurité ou à la poursuite du traitement.
[SOURCE : ISO 17664-2:2021, 3.1, modifié — « et/ou » remplacé par « ou ».]
201.3.206
raccord
pièce destinée à établir une liaison de continuité entre deux ou plusieurs composants
EXEMPLE Les raccords destinés aux flexibles de raccordement à basse pression sont tout élément d'une gamme
d'éléments d'accouplement destinés à maintenir la spécificité du gaz par l'attribution d'un ensemble de diamètres
différents aux raccords d'accouplement pour chaque gaz particulier.
[SOURCE : ISO 4135:2022, 3.1.4.5]
201.3.207
économiseur
appareil EM prévu pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente
et synchronisée en suivant le cycle d'inspiration du patient
Note 1 à l'article : Un économiseur peut être doté d'une alimentation électrique ou pneumatique.
201.3.208
économiseur doté d'une fonction de surveillance
économiseur destiné à être utilisé chez des patients pour lesquels une surveillance de la fourniture d'oxygène
via l'économiseur est indiquée
201.3.209
cybersécurité
état de protection des informations et des systèmes contre les activités non autorisées telles que l'accès,
l'utilisation, la divulgation, l'interruption, la modification ou la destruction à un degré auquel les risques liés à
la violation de la confidentialité, de l'intégrité et de la disponibilité sont maintenus à un niveau acceptable
tout au long du cycle de vie
[SOURCE : IEC 81001-5-1:2021, 3.30]
201.3.210
désinfection
procédé visant à inactiver des micro-organismes viables à un niveau préalablement spécifié comme
approprié pour une utilisation définie
[SOURCE : ISO 17664-2:2021, 3.5]
ISO/FDIS 80601-2-67:2025(fr)
201.3.211
fonction essentielle
fonction ou capacité nécessaire au maintien de la sécurité de base, des performances essentielles, du minimum
de fonctionnalité clinique tel que spécifié par le fabricant et de la disponibilité opérationnelle du dispositif
médical
Note 1 à l'article : Les fonctions essentielles comprennent, sans toutefois s'y limiter, la fonction équipée pour la sécurité
(sécurité de base et performances essentielles), la fonction de commande et la disponibilité immédiate de fonctions
indispensables qui permettent à l'opérateur de voir et de manipuler le dispositif médical en toute sécurité, tout en
assurant le maintien des performances minimales (disponibilité opérationnelle). La perte d'une fonction essentielle est
communément appelée « perte de protection », « perte de contrôle » ou « perte de visibilité », selon le cas.
Note 2 à l'article : Le terme est issu de l'IEC 62443-4-2:2019, 3.1.20, et sa définition a été adaptée pour les besoins et le
domaine d'application du présent document.
[SOURCE : IEC/TR 60601-4-5:2021, 3.10]
201.3.212
principes essentiels
principes essentiels de sécurité et de performance
exigences fondamentales de haut niveau qui, lorsqu'elles sont respectées, assurent qu'un dispositif médical
est sûr et fonctionne comme prévu
[SOURCE : ISO 16142-1:2016, 3.3]
201.3.213
orifice d'évacuation
orifice de l'équipement ou du dispositif médical à partir duquel le gaz est évacué dans l'atmosphère en
utilisation normale, soit directement, soit via un système d'évacuation des gaz anesthésiques
[SOURCE : ISO 19223:2019, 3.14.2]
201.3.214
appel d'urgence
méthode établie permettant de fournir un accès d'urgence à un dispositif médical sécurisé
Note 1 à l'article : Dans une situation d'urgence, des utilisateurs non privilégiés peuvent avoir accès aux systèmes clés
pour corriger le problème. Lorsqu'un appel d'urgence est utilisé, un processus de révision est généralement prévu afin
de s'assurer que l'accès a été utilisé correctement pour corriger un problème. Ces méthodes prévoient généralement un
identifiant (ID) d'utilisateur à usage unique ou un mot de passe à usage unique ou d'autres mesures appropriées.
Note 2 à l'article : Également appelé fonction « bris de glace ».
[SOURCE : IEC/TR 60601-4-5:2021, 3.11]
ISO/FDIS 80601-2-67:2025(fr)
201.3.215
dispositif sensible au sens du débit
dispositif ou accessoire à travers lequel le courant gazeux ne s'écoule que dans une seule direction pour que
soient assurés le fonctionnement correct du dispositif et/ou la sécurité du patient
[SOURCE : ISO 4135:2022, 3.1.4.15, modifié — Ajout de « ou accessoire » et remplacement de « ne doit
s'écouler que » par « ne s'écoule que ».]
201.3.216
orifice d'aspiration du gaz
orifice par lequel le gaz est aspiré pour être utilisé par le patient
Note 1 à l'article : Le gaz est aspiré à une pression sub-ambiante au niveau d'un orifice d'aspiration du gaz, en
opposition à une entrée, au niveau duquel le gaz est fourni par un système d'alimentation en gaz médicaux.
[SOURCE : ISO 4135:2022, 3.1.4.21, modifié — « apposition » remplacé par « opposition ».]
201.3.217
chemin de gaz
surfaces intérieures sur lesquelles s'écoulent les gaz ou les liquides pouvant être inspirés
EXEMPLE 1 Système respiratoire du ventilateur, filtre d'entrée, mélangeur de gaz, turbine et tuyauterie interne.
EXEMPLE 2 Chambre fermée d'un incubateur, y compris le matelas ou la surface intérieure d'une cloche de Hood.
EXEMPLE 3 Surfaces intérieures des tubes respiratoires, des sondes trachéales ou des masques et les embouts.
Note 1 à l'article : Le chemin de gaz est délimité par les orifices par lesquels les gaz ou les liquides entrent dans le
dispositif médical. Cela peut inclure l'interface patient ou les surfaces intérieures des enveloppes en contact avec les gaz
ou les liquides pouvant être inspirés.
Note 2 à l'article : Le chemin de gaz peut inclure certaines surfaces du chemin expiratoire.
Note 3 à l'article : Les surfaces en contact avec le patient, telles que les surfaces extérieures d'une sonde trachéale ou le
coussinet d'un masque respiratoire, sont évaluées conformément à la série de normes ISO 10993.
[SOURCE : ISO 18562-1:2024, 3.11]
201.3.218
entrée à haute pression
entrée où le gaz est administré à une pression dépassant de plus de 100 kPa la pression ambiante
Note 1 à l'article : Les termes « basse pression » et « haute pression » sont utilisés différemment selon le contexte
auquel ils se rapportent, par exemple pressions de système respiratoire (habituellement inférieures à 10 kPa),
pressions de sortie de prise (inférieures à 600 kPa), pressions de rampe (habituellement jusqu'à 3 000 kPa) et
pressions de bouteille (habituellement inférieures à 30 000 kPa).
[SOURCE : ISO 4135:2022, 3.1.4.24]
ISO/FDIS 80601-2-67:2025(fr)
201.3.219
environnement des soins à domicile
habitation dans laquelle un patient vit ou autres environnements où des patients sont présents, à l'exclusion
des environnements des établissements de soins où des opérateurs ayant une formation médicale sont
disponibles de façon continue lorsque des patients sont présents
EXEMPLE Dans une voiture, un autobus, un train, un bateau ou un avion, dans un fauteuil roulant, ou marchant à
l'extérieur.
Note 1 à l'article : Les établissements de soins comprennent les hôpitaux, les cabinets médicaux, les centres
chirurgicaux indépendants, les cabinets dentaires, les centres d'accouchement indépendants, les établissements de
soins en résidence, les postes de premiers soins ou les postes de secours, les établissements multitraitements et les
services médicaux d'urgence.
Note 2 à l'article : Les centres d'hébergement sont considérés comme des environnements de soins à domicile.
Note 3 à l'article : D'autres environnements où un patient est présent incluent l'environnement extérieur, au travail et
l'intérieur des véhicules.
[SOURCE : IEC 60601-1-11:2015+AMD1:2020, 3.1, modifié — « Pour les besoins de la présente norme
collatérale, » supprimé.]
201.3.220
rapport I/E
rapport entre la durée inspiratoire et la durée expiratoire dans un cycle respiratoire
[SOURCE : ISO 19223:2019, 3.4.19, modifié — Notes supprimées.]
201.3.221
immunité
aptitude d'un appareil EM ou d'un système EM à fonctionner sans dégradation en présence d'une
perturbation électromagnétique
[SOURCE : IEC 60601-1-2:2014+AMD1:2020, 3.8]
201.3.222
informations fournies par le fabricant
toutes les informations associées à l'identification et à l'utilisation d'un dispositif médical ou d'un accessoire,
quelle que soit la forme sous laquelle elles sont fournies, destinées à assurer l'utilisation sûre et efficace du
dispositif médical ou de l'accessoire
Note 1 à l'article : Pour les besoins du présent document, la documentation électronique est incluse dans les
informations fournies par le fabricant.
Note 2 à l'article : Pour les besoins du présent document, les documents d'expédition et le matériel publicitaire sont
exclus des informations fournies par le fabricant. Cependant, certaines autorités compétentes peuvent considérer que ces
informations complémentaires sont des informations fournies par le fabricant.
ISO/FDIS 80601-2-67:2025(fr)
Note 3 à l'article : L'objectif principal des informations fournies par le fabricant consiste à identifier un dispositif médical
et son fabricant et à fournir des informations cruciales sur sa sûreté, sa performance et son utilisation appropriée à
l'utilisateur ou à d'autres personnes concernées.
[SOURCE : ISO 20417:2021, 3.10, modifié — Note 4 supprimée.]
201.3.223
entrée
ouverture à travers laquelle un gaz ou une autre substance est poussé par une pression amont élevée
[SOURCE : ISO 4135:2022, 3.1.4.26, modifié — Note supprimée.]
201.3.224
durée inspiratoire
t
I
durée d'une phase d'insufflation ou d'une phase inspiratoire
[SOURCE : ISO 19223:2019, 3.4.8, modifié — Notes supprimées.]
201.3.225
instructions d'utilisation
partie des informations d'accompagnement qui est essentielle pour l'utilisation sûre et efficace d'un dispositif
médical ou d'un accessoire et qui est destinée à l'utilisateur du dispositif médical
Note 1 à l'article : Pour les besoins du présent document, un utilisateur peut être soit un utilisateur profane, soit un
utilisateur professionnel ayant reçu une formation spécialisée appropriée.
Note 2 à l'article : Pour les besoins du présent document, les instructions relatives au traitement professionnel entre
des utilisations d'un dispositif médical ou d'un accessoire peuvent être incluses dans les instructions d'utilisation.
Note 3 à l'article : Pour les besoins du présent document, les informations indiquées sur une interface utilisateur
graphique (IUG) sont considérées comme apparaissant sur l'élément.
Note 4 à l'article : Les instructions d'utilisation, ou des parties de ces instructions, peuvent être affichées par un
dispositif médical ou un accessoire.
Note 5 à l'article : Les dispositifs médicaux ou les accessoires qui peuvent être utilisés en toute sécurité et de manière
efficace sans instructions d'utilisation sont exemptés de l'exigence d'être accompagnés d'instructions d'utilisation par
certaines autorités compétentes.
[SOURCE : ISO 20417:2021, 3.11, modifié — Note 6 supprimée.]
201.3.226
profane
personne non spécialiste
terme faisant référence à un professionnel ou à un non professionnel n'ayant pas reçu une formation
spécialisée appropriée
ISO/FDIS 80601-2-67:2025(fr)
EXEMPLE Opérateur non spécialiste, organisme responsable non spécialiste.
[SOURCE : IEC 60601-1-11:2015+AMD1:2020, 3.2]
201.3.227
flexible de raccordement à basse pression
ensemble composé d'un flexible équipé de raccords d'entrée et de sortie spécifiques à un gaz fixés en
permanence et prévu pour le transport d'un gaz médical à des pressions inférieures à 1 400 kPa
Note 1 à l'article : Les termes « basse pression » et « haute pression » sont utilisés différemment selon le contexte
auquel ils se rapportent, par exemple pressions de système respiratoire (habituellement inférieures à 10 kPa),
pressions de sortie de prise (inférieures à 1 400 kPa), pressions de rampe (habituellement jusqu'à 3 000 kPa) et
pressions de bouteille (habituellement inférieures à 30 000 kPa).
[SOURCE : ISO 4135:2022, 3.2.3.1]
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