EN ISO 10651-4:2023

SLOVENSKI STANDARD
01-junij-2023
Nadomešča:
SIST EN ISO 10651-4:2009
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja
uporabnik (ISO 10651-4:2023)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO
10651-4:2023)
Beatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene
Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2023)
Ventilateurs pulmonaires - Partie 4 : Exigences relatives aux ressuscitateurs actionnés
par l’utilisateur (ISO 10651-4:2023)
Ta slovenski standard je istoveten z: EN ISO 10651-4:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10651-4
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10651-4:2009
English Version
Lung ventilators - Part 4: Particular requirements for user-
powered resuscitators (ISO 10651-4:2023)
Ventilateurs pulmonaires - Partie 4 : Exigences Beatmungsgeräte - Teil 4: Anforderungen an
relatives aux ressuscitateurs actionnés par l'utilisateur anwenderbetriebene Wiederbelebungsgeräte
(ISO 10651-4:2023) (Handbeatmungsgeräte) (ISO 10651-4:2023)
This European Standard was approved by CEN on 17 February 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-4:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10651-4:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2023, and conflicting national standards shall
be withdrawn at the latest by October 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10651-4:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10651-4:2023 has been approved by CEN as EN ISO 10651-4:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 10651-4
Second edition
2023-03
Lung ventilators —
Part 4:
Particular requirements for user-
powered resuscitators
Ventilateurs pulmonaires —
Partie 4: Exigences relatives aux ressuscitateurs actionnés par
l’utilisateur
Reference number
ISO 10651-4:2023(E)
ISO 10651-4:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10651-4:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for testing of a resuscitator.15
4.1 Risk management process . .15
4.2 Type tests . 16
4.3 Test conditions . 16
4.4 Gas flowrate, volume and leakage specifications . 17
4.5 Testing errors . 17
4.6 Environmental conditions in the end user environment . 18
4.6.1 Transport and storage conditions . 18
4.6.2 Operating conditions . 19
4.6.3 Shelf-life . 20
4.6.4 Expected lifetime. 20
5 Information supplied by the manufacturer .21
5.1 General . 21
5.2 Additional marking requirements . 22
5.3 Additional instructions for use requirements . 22
6 Connectors and ports .23
6.1 General .23
6.2 Patient-connection port .23
6.3 Expiratory port connector for breathing gases . 23
6.4 Face mask connectors . 24
6.5 Intake connectors . 24
6.6 Bag refill valve connector. 24
6.7 Oxygen inlet connection . . .25
6.8 Pressure monitor connector . 26
7 Operational requirements .26
7.1 Dismantling and reassembly .26
7.2 Resuscitator performance after contamination with vomitus . 26
7.3 Mechanical strength . 27
7.4 Resistance to separation from an axial load . 27
7.4.1 Multiple patient multiple use resuscitators .28
7.4.2 Single use and single patient multiple use resuscitators .28
7.5 Immersion in water .29
7.6 Bag refill valve .29
7.7 Compatibility with substances .29
8 Ventilatory requirements .30
8.1 Delivered oxygen concentration .30
8.1.1 Non-spontaneously breathing patient .30
8.1.2 Spontaneously breathing patient . 31
8.2 Expiratory resistance .33
8.3 Inspiratory resistance .34
8.4 Gas source excessive flow .34
8.5 Resuscitator deadspace . 35
8.6 Ventilation performance . 35
8.6.1 Minimum guaranteed tidal volume (V ) — one hand . 35
T
8.6.2 Minimum guaranteed tidal volume for B < 2,5 kg .36
8.6.3 Maximum deliverable tidal volume — two hands . 37
iii
ISO 10651-4:2023(E)
8.6.4 Maximum limited pressure .38
9 Additional requirements for resuscitator parts and accessories .39
9.1 General .39
9.2 Labelling .40
9.3 Breathing system filters .40
9.4 Stand-alone gas mixer .40
10 Processing requirements for a resuscitator and its accessories that are reusable .40
11 Biocompatibility .41
12 Usability .41
Annex A (informative) Particular guidance and rationale .43
Annex B (informative) Guide to marking and labelling requirements for resuscitators and
their accessories .49
Annex C (informative) Symbols on marking .52
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances .55
Annex E (informative) Reference to the essential principles .58
Annex F (informative) Reference to the general safety and performance requirements .60
Bibliography .63
Terminology — Alphabetized index of defined terms .65
iv
ISO 10651-4:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Respiratory devices and related equipment used for patient care, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 10651-4:2002), which has been
technically revised.
The main changes are as follows:
— clarified scope to include flow-inflating bag and self-inflating bag resuscitators and also indicated
that the requirements include specified accessories;
— updated normative references and defined terms;
— specified test conditions;
— specified calculation and disclosure of measurement uncertainty;
— harmonized storage and operating environmental conditions;
— added requirements for shelf-life and expected lifetime;
— harmonized information supplied by the manufacturer with ISO 20417 and ISO 15223-1;
— added requirements for the oxygen inlet connector;
— clarified ventilatory testing requirements;
— clarified delivered oxygen concentration performance requirements;
— added processing requirements;
v
ISO 10651-4:2023(E)
— added biocompatibility requirements; and
— added usability requirements.
A list of all parts in the ISO 10651 series can be found on the ISO website.
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.
vi
ISO 10651-4:2023(E)
Introduction
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.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in this document: italic type;
— 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 this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" indicates a possibility or a capability;
— "must" indicates an external constraint.
Annex A contains rationale or guidance to some of the requirements in this document.
Annex B contains a guide to the marking and labelling requirements in this document.
Annex C 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
INTERNATIONAL STANDARD ISO 10651-4:2023(E)
Lung ventilators —
Part 4:
Particular requirements for user-powered resuscitators
1 Scope
This document specifies requirements for user-powered resuscitators intended for use with all age
groups and which are intended to provide lung ventilation to patients whose breathing is inadequate.
User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic
recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of
environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow
from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where
the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers,
metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic
feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
[24] [25]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance
[23]
requirements of European regulation (EU) 2017/745 as indicated in Annex F.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10651-4:2023(E)
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11195:2018, Gas mixers for medical use — Stand-alone gas mixers
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 14971:2019, Medical devices — Application of risk management to medical devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
1)
ISO 80369-2:—, Small-bore connectors for liquids and gases in healthcare applications — Part 2:
Connectors for breathing systems and driving gases applications
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
primarily for equipment-type specimens
IEC 62366-1:2015+AMD1: 2020, Medical devices — Part 1: Application of usability engineering to medical
devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2021, 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, an alphabetized index of terms and their sources used in this document is found at
the end of this document.
1)  Under preparation. Stage at the time of publication: ISO/DIS 80369-2:2021.
ISO 10651-4:2023(E)
3.1
accessory
item, intended specifically by its manufacturer, to be used together with one or more medical devices to
specifically enable or assist those medical devices to be used in accordance with their intended use
Note 1 to entry: An accessory is typically a consumable or separate item for use with one or more medical devices.
Note 2 to entry: Some authorities having jurisdiction consider an accessory to be a medical device.
Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory.
[SOURCE: ISO 20417:2021, 3.1]
3.2
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2021, 3.2, modified —deleted notes 4 to 7.]
3.3
airway pressure
pressure at the patient-connection port, relative to ambient pressure unless otherwise specified
Note 1 to entry: In addition to its direct reference, this term or its symbol P , displayed in various character
aw
styles, is only used, in context or by qualification, to designate this concept as a measured quantity.
Note 2 to entry: The site(s) of actual measurement(s) may be anywhere in the ventilator breathing system,
providing that the indicated value is referenced to that at the patient-connection port.
Note 3 to entry: This is the generic term for this fundamental concept. Post-coordinated terms, for example, peak
inspiratory pressure and baseline airway pressure, are used in particular contexts.
Note 4 to entry: Although providing no explicit indication as to where along the patient's airway this pressure
is measured, this term, along with its symbol, has become widely adopted as referencing the pressure at the
point at which artificial ventilation equipment is connected to the patient's airway or to an airway device. This
is the final site where a common and replicable pressure can be continuously monitored, conveniently, before
breathing gas enters the patient.
Note 5 to entry: A pressure measured in the patient's airway at a site other than at the patient-connection port is
referred to in this document as a respiratory pressure.
[SOURCE: ISO 19223:2019, 3.6.1 modified — deleted notes 6 and 7.]
3.4
atmospheric temperature and pressure
ATP
expressed at ambient atmospheric pressure and temperature
3.5
bag inlet valve
valve activated by the sub-atmospheric pressure in the compressible
unit of the resuscitator to refill the compressible unit with gas at ambient pressure
[SOURCE: ISO 4135:2022, 3.6.1.3.1, modified — added context.]
ISO 10651-4:2023(E)
3.6
bag refill valve
accessory valve activated by the sub-atmospheric pressure in the
compressible unit of the resuscitator to refill the compressible unit from a pressurized oxygen source
[SOURCE: ISO 4135:2022, 3.6.1.3.2, modified — added context and accessory, replaced 'gas' with 'oxygen'
and deleted 'with no manual trigger'.]
3.7
BAP
quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure
[SOURCE: ISO 19223:2019, 3.10.2, modified — deleted notes.]
3.8
biocompatibility
ability to be in contact with a living system without producing an unacceptable adverse effect
Note 1 to entry: Medical devices may produce some level of adverse effect, but that level may be determined to be
acceptable when considering the benefits provided by the medical device.
[SOURCE: ISO 18562-1:2017, 3.2]
3.9
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in a breathing
system
[SOURCE: ISO 4135:2022, 3.6.1.5]
3.10
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal, usually with detergent and water, 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 17664-1:2021, 3.1]
3.11
clearly legible
capable of being read by a person with normal vision
[SOURCE: ISO 20417:2021, 3.4]
3.12
compressible unit
part of a user-powered resuscitator e.g. a bag or bellows that, when squeezed by the user, delivers a
volume of gas
[SOURCE: ISO 4135:2022, 3.4.1.11, modified —replaced 'compressed' by 'squeezed'.]
3.13
delivered oxygen concentration
concentration of oxygen in the gas delivered to a patient
[SOURCE: ISO 4135:2022, 3.1.1.14, modified —deleted example.]
ISO 10651-4:2023(E)
3.14
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
[SOURCE: ISO 17664-1:2021, 3.3]
3.15
e-documentation
any form of electronically accessible information supplied by the manufacturer related to a medical device
or accessory
EXAMPLE CD/DVD-ROM, USB stick, website.
[SOURCE: ISO 20417:2021, 3.6, modified —deleted note 1.]
3.16
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]
3.17
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
Note 1 to entry: A resuscitator may have more than one exhaust port.
[SOURCE: ISO 19223:2019, 3.14.2, modified —added note.]
3.18
expected lifetime
time period specified by the manufacturer during which the medical device or accessory is expected to
remain safe and effective for use
Note 1 to entry: The expected lifetime can be affected by the stability.
Note 2 to entry: Maintenance, repairs or upgrades (e.g. safety or cybersecurity modifications) can be necessary
during the expected lifetime.
Note 3 to entry: Some medical devices have an absolute lifetime (e.g. 5 years), whereas other medical devices (e.g.
software) have a relative lifetime (e.g. the time between two major releases).
[SOURCE: ISO 20417:2021, 3.7]
3.19
expiratory phase
interval from the start of expiratory flow to the start of inspiratory flow within a respiratory cycle
[SOURCE: ISO 19223:2019, 3.4.2, modified — deleted notes.]
3.20
forward leakage
volume of gas produced by the resuscitator during the inflation phase which does not pass through the
patient-connection port to the patient but passes to the atmosphere
ISO 10651-4:2023(E)
3.21
gas pathway
interior surfaces, over which gases or liquids that can be inspired, in a medical device bounded by the
ports through which gases or liquids enter and leave the medical device including the patient interface
or the interior surfaces of enclosures that are in contact with gases or liquids that can be inspired
Note 1 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.
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.
[SOURCE: ISO 18562-1:2017, 3.5]
3.22
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO 14971:2019, 3.3]
3.23
hazard
potential source of harm
[SOURCE: ISO 14971:2019, 3.4]
3.24
hazardous situation
circumstance in which people, property or the environment is/are exposed to one or more hazards
[SOURCE: ISO 14971:2019, 3.5, modified — deleted note 1.]
3.25
inflation phase
interval from the start of the rise in airway pressure resulting from the initiation of an inflation to the
start of the expiratory flow resulting from its termination
[SOURCE: ISO 19223:2019, 3.4.10, modified — deleted notes.]
3.26
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.]
ISO 10651-4:2023(E)
3.27
inspiratory time
t
I
duration of an inflation phase or inspiratory phase
[SOURCE: ISO 19223:2019, 3.4.8, modified — deleted notes.]
3.28
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: The instructions for use, or portions thereof, can be located on the display of a medical device or
accessory.
Note 4 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 5.]
3.29
intake
opening through which gas or other material is drawn by a sub-ambient pressure
[SOURCE: ISO 4135:2022, 3.1.4.27]
3.30
intended use
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
[SOURCE: ISO 14971:2019, 3.6]
3.31
label
written, printed, or graphic information appearing on the item itself, on the
packaging of each item or on the packaging of multiple items
Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act.
Note 2 to entry: Label includes the marking on the medical device or accessory.
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.
[SOURCE: ISO 20417:2021, 3.12, modified —deleted note 4.]
3.32
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
Note 1 to entry: In specific reference to the pair of these organs, in this document the inflection ‘lungs’ is used.
ISO 10651-4:2023(E)
Note 2 to entry: In accordance with what has become common practice in the absence of a more suitable term,
this term in its singular form is also used in this document to reference the connected, respiratory-gas containing
cavities within the respiratory system, consisting of the airway and the lungs. Examples of this common practice
in applications that are outside the scope of this document are: lung function; lung disease; lung compliance; lung
mechanics; test lung. Other established examples are lung ventilator; lung elastance; lung protective strategy.
Note 3 to entry: Although there are no such references in this document, if in the application of this document
a need arises to refer to just ‘one of the lungs’ then, in order to avoid any possible ambiguity, it should always be
identified as such, or as the ‘left lung’ or ‘right lung’.
[SOURCE: ISO 19223:2019, 3.1.16, modified —deleted note 4.]
3.33
manufacturer
natural or legal person with responsibility for the design and/or manufacture of a medical device with
the intention of making the medical device available for use, under his name, whether or not such a
medical device is designed and/or manufactured by that person himself or on his behalf by another
person(s)
Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all
applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to
be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory
Authority (RA) within that jurisdiction.
Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These
responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse
event reporting and notification of corrective actions.
Note 3 to entry: “Design and/or manufacture” may include specification development, production, fabrication,
assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing
of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another
person for an individual patient, in accordance with the instructions for use, is not the ma
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