EN ISO 18562-1:2024

SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 18562-1:2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-
1:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO 18562-1:2024)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (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 18562-1:2024)
Ta slovenski standard je istoveten z: EN ISO 18562-1:2024
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 18562-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18562-1:2020
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing
within a risk management process (ISO 18562-1:2024)
Évaluation de la biocompatibilité des chemins de gaz Beurteilung der Biokompatibilität der Atemgaswege
respiratoire utilisés dans le domaine de la santé - bei medizinischen Anwendungen - Teil 1: Beurteilung
Partie 1: Évaluation et essais au sein d'un processus de und Prüfung innerhalb eines Risikomanagement-
gestion du risque (ISO 18562-1:2024) Prozesses (ISO 18562-1:2024)
This European Standard was approved by CEN on 15 March 2024.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18562-1:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4

European foreword
This document (EN ISO 18562-1:2024) 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 April 2025, and conflicting national standards shall be
withdrawn at the latest by April 2025.
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 18562-1:2020.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
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 18562-1:2024 has been approved by CEN as EN ISO 18562-1:2024 without any
modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in Table ZA.3 in this Annex Z. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in
this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745.
For application of this European standard under Regulation (EU) 2017/745, its scope is limited to
medical devices for use with human patients. This affects all clauses of this European standard.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical investigations,
clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
10.1 a) Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess toxicity of
substances added by the medical device
to the gas pathways of manufactured
medical devices. Other forms of toxicity
and flammability are not covered.
10.1 b) Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess toxicity of
substances added by the medical device
to the gas pathways of manufactured
medical devices.
10.2 Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture and packaging. However,
this standard provides a means to assess
risks to the patient associated with the
toxicity of substances added by the
medical device to the gas pathways of
manufactured medical devices. Risks to
other persons involved in the transport,
storage and use of the devices are not
covered.
10.3 Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. Only the aspects relating to
contamination of medical gases by
contact with the gas pathways are
covered.
Risks to the patient associated with
medicinal substances added to the gas
stream are not covered.
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
10.4.1 (first paragraph) Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess risks to the
patient associated with the toxicity of
substances added by the medical device
to the gas pathways of manufactured
medical devices. This does not include all
aspects of degradation as these cannot be
fully evaluated using the tests of ISO
18562 alone. Other forms of toxicity are
not covered.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 10993-1:2018 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 10993- ISO 10993-17:2023 Biological evaluation of EN ISO 10993-17:2023
17:2023 medical devices — Part 17:
Toxicological risk assessment
of medical device constituents
ISO 14971:2019 ISO 14971:2019 Medical devices — Application EN ISO 14971:2019
of risk management to
EN ISO 14971:2019/A11:2021
medical devices
ISO 18562-2:2024 ISO 18562-2:2024 Biocompatibility evaluation of EN ISO 18562-2:2024
breathing gas pathways in
healthcare applications —
Part 2: Tests for emissions of
particulate matter
ISO 18562-3:2024 ISO 18562-3:2024 Biocompatibility evaluation of EN ISO 18562-3:2024
breathing gas pathways in
healthcare applications —
Part 3: Tests for emissions of
volatile organic substances
ISO 18562-4:2024 ISO 18562-4:2024 Biocompatibility evaluation of EN ISO 18562-4:2024
breathing gas pathways in
healthcare applications —
Part 4: Tests for leachables in
condensate
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.

Table ZA.3 — Prevailing terms of Regulation (EU) 2017/745
for use of this European standard under that Regulation
Term used Clause / Article in (EU) Differences / Consequences
in this EN sub-clause 2017/745 that
where this defines or uses this
term is term
defined in
this EN
Accessory 3.2 Term defined in Art. For use under MDR, only “accessories for a
2(2) medical device” are in focus, instead of
accessories “for use with equipment”. Art. 1(4)
of MDR summarizes medical devices and
accessories for medical devices as “devices” for
diverse requirements throughout the MDR.
Annex VIII 3.2 requires classification of
accessories in their own right; Annex II 1
requires technical documentation of
accessories.
Hazard 3.12 Legally relevant term For use under MDR, the term only refers to
used in Art. 1(12), potential sources of harm in the meaning of
Art. 106, GSPR 3 et al. harm as listed above. This is the only
difference in the meaning of harm in MDR and
in this EN.
Manufacturer 3.17 Term defined in Art. For use under MDR, the term includes also full
2(30) refurbishment as well as marketing of a device
under its name or trademark.
Patient 3.23 Legally relevant term For use under MDR, the term only refers to
used in Art. 2 (3,4,36, medical devices for human use, but not to
52) et al. medical devices for use on animals.
Process 3.24 Legally relevant term No difference between the use of the term in
used in Art. 2 (1,17,39, MDR and the definition in this EN. For use
40,44,71), Art. 5,10, under MDR, the specifically addressed process
GSPR 3, 13.1 et al. in the context of the term applies (e.g.,
manufacturing process, risk management
process, handling processes, conformity
assessment process, reprocessing process,
physiological process, clinical evaluation
process, reporting / monitoring process).
Residual Risk 3.26 Legally relevant term No difference between the use of the term in
used in Art. 32, GSPR MDR and the definition in this EN. For use
4,10.4.5,23.1 et al. under MDR, the specifically addressed residual
risk in the context of the term applies (e.g.,
residual risk associated with each hazard,
overall residual risk).
Term used Clause / Article in (EU) Differences / Consequences
in this EN sub-clause 2017/745 that
where this defines or uses this
term is term
defined in
this EN
Risk 3.27 Term defined in Art. Identical definitions in MDR and this standard,
2(23) however, MDR has a narrower meaning of the
term “harm” used in the definition for risk, see
above, which prevails for use of this EN under
the MDR.
Risk 3.31 Legally relevant term GSPR 3 to 5 of MDR provide more detailed (but
cations of the term
Management used in Art. 1,8,10 et al., not contradicting) specifi
GSPR 3,17.2 et al. than in the definition of this EN. However, in
contrast to use in MDR, the note to the
definition in this EN and the requirements in
4.2.2 exclude risk management activities of
planning for and monitoring of production and
post-production information. For use under
MDR, the use of the MDR term “risk
management” prevails and the GSPR coverage
of this EN is limited, accordingly.

International
Standard
ISO 18562-1
Second edition
Biocompatibility evaluation
2024-03
of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk
management process
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
Reference number
ISO 18562-1:2024(en) © ISO 2024

ISO 18562-1:2024(en)
© ISO 2024
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 18562-1:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles applying to biocompatibility evaluation of medical devices .11
4.1 General .11
4.2 Type tests .14
4.3 Biocompatibility hazard identification .14
4.4 Extent of risk assessment . . 15
4.5 Biological evaluation plan . 15
4.6 Selection of tests .17
4.7 Subsequent evaluation .18
5 Contamination of breathing gas from gas pathways . 19
5.1 Duration of use .19
5.2 Particulate matter (PM) emissions .19
5.3 Volatile organic substance emissions . 20
5.4 Leachables in condensate . 20
6 Adjustment of exposure dose and inhalation dose for different patient groups .20
6.1 General considerations. 20
6.2 Adjustment for different patient groups . 20
7 Deriving tolerable exposure (TE) for VOS .21
7.1 General process .21
7.2 For medical devices intended for limited exposure use (≤24 h) and prolonged exposure
use (>24 h but <30 d) . 22
7.3 For medical devices intended for long-term exposure (≥30 d) . 23
8 Determining values for leachables in condensate .23
8.1 General . 23
8.2 Adjustments for different patient groups .24
8.3 Exposure dose estimate for condensate .24
9 Risk control .24
10 Benefit-risk analysis .24
11 Biological evaluation report . .25
Annex A (informative) Rationale and guidance .26
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .28
Annex C (informative) Reference to the essential principles .30
Annex D (informative) Terminology — Alphabetized index of defined terms.31
Bibliography .33

iii
ISO 18562-1:2024(en)
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 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes 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 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. ISO 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.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, in collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 18562-1:2017), which has been technically
revised.
The main changes are as follows:
— added informative mapping annexes to relevant regulatory requirements;
— clarified terms and definitions used in the document;
— expanded the patient groups to include: premature, small child, child, and adolescent;
— introduction of inhalation dose;
— the threshold of toxicological concern is changed;
— expanded the range of volatile organic substances that are tested;
— clarified the appropriate breathing gas volumes to be used in testing for VOS; and
— clarified the appropriate breathing gas volumes to be used in the analysis.
A list of all parts in the ISO 18562 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.

iv
ISO 18562-1:2024(en)
Introduction
This document represents the application of the best-known science, in order to improve patient safety, by
addressing the risk of potentially hazardous substances being conveyed to the patient by the gas stream.
This document is intended to cover the biological evaluation of gas pathways of medical devices within a
risk management process, as part of the overall medical device evaluation and development. This approach
combines the review and evaluation of existing data from all sources with, where necessary, the selection
and application of additional tests.
In general, the ISO 10993 series is intended to cover the biological evaluation of medical devices. However,
the ISO 10993 series does not sufficiently address the biological evaluation of the gas pathways of medical
devices.
Before this document was developed, some authorities having jurisdiction interpreted the ISO 10993-1:2009,
Table A.1 to mean that as materials in the gas pathway form “indirect contact” with the patient, they
should be subjected to tests equivalent to those required for tissue contact parts of medical devices. This
interpretation can lead to tests that are not optimized for evaluation of gas pathways including possible
hazards not being detected.
ISO 10993-1:2018 states that it is not intended to provide a rigid set of test methods as this might result in an
unnecessary constraint on the development and use of novel medical devices. ISO 10993-1:2018 also states
where a particular application warrants it, experts in the product or in the area of application concerned
can choose to establish specific tests and criteria, described in a product-specific vertical standard. This
series of standards is intended to address the specific needs for the evaluation of gas pathways that are not
adequately covered by ISO 10993-1:2018.
This document provides a guide to the development of a biological evaluation plan that minimizes the number
and exposure of test animals by giving preference to chemical constituent testing and in vitro models.
The initial version of this series of standards was intended to cover only the most commonly found
potentially harmful substances. It was felt that it was best to get a functioning document published that
would test for the bulk of the currently known substances of interest. With the use of the TTC (threshold of
toxicological concern) approach, this document has the potential to be used to assess the safety of essentially
any compound released from the gas pathways of respiratory medical devices, with very few exceptions (e.g.
PCBs, dioxins), and not just the most commonly found potentially harmful substances.
ISO 18562-1 does not address all possible biological hazards that can be associated with gas pathways.
Other, additional evaluations can be appropriate. These evaluations can require further risk control before
finishing the biological evaluation.
Future parts of this series might be added to this series to address other relevant aspects of biological
testing including additional contamination that might arise from the gas pathway because of the presence of
drugs and anaesthetic agents added to the gas stream, and potential contamination by emission of inorganic
gases such as ozone, CO, CO , and NO .
2 x
NOTE Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.
This document has been prepared in consideration of:
— the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/
[13]
GRRP WG/N47:2018 as indicated in Annex B;
[14]
— the Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N52:2019 as
indicated in Annex B;
— the essential principles of safety and performance of a medical device according to ISO 16142-1:2016 as
indicated in Annex C; and
— the general safety and performance requirements of a medical device according to regulation
[15]
(EU) 2017/745 .
v
ISO 18562-1:2024(en)
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 capability.

vi
International Standard ISO 18562-1:2024(en)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
1 Scope
This document specifies:
— the general principles governing the biological evaluation within a risk management process of the gas
pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or
supply substances via the respiratory tract to a patient in all environments;
— the general categorization of gas pathways based on the nature and duration of their contact with the gas
stream;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
— the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device materials,
which make up the gas pathway, in normal use and normal condition. This document does not cover biological
hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are
added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways within
the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the
instructions for use. This includes degradation arising from exposure to environmental conditions as well
as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission)
that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/
intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by
the manufacturer (i.e. abnormal use).
This document does not address biological evaluation of the surfaces of medical devices that have direct
contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993
series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include,
but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems,
oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers,
heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory
[23][25][28-30]
personal protective equipment , mouth pieces, resuscitators, breathing tubes, breathing system
filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The
enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are
considered to be gas pathways and are also addressed by this document.

ISO 18562-1:2024(en)
This document does not address contamination already present in the gas supplied from the gas sources
while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems
(including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a
medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).
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 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-17:2023, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical
device constituents
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 18562-2:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2:
Tests for emissions of particulate matter
ISO 18562-3:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3:
Tests for emissions of volatile organic substances
ISO 18562-4:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4:
Tests for leachables in condensate
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 in
Annex D.
3.1
abnormal use
conscious, deliberate act or deliberate omission of an act that is counter to or violates normal use and is also
beyond any further reasonable means of user interface-related risk control by the manufacturer
EXAMPLE Reckless use or sabotage or intentional deliberate disregard of information for SAFETY are such acts.
Note 1 to entry: An intended but erroneous action that is not abnormal use is considered a type of use error.
Note 2 to entry: Abnormal use does not relieve the manufacturer from considering non-user interface-related means of
risk control.
Note 3 to entry: Figure 1 shows the relationships of the types of use.

ISO 18562-1:2024(en)
Figure 1 — Relationship of the types of use
[SOURCE: IEC 62366-1+AMD1: 2020, 3.1, modified — deleted note 1.]
3.2
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]
3.3
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or
accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory,
visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
3.4
authority having jurisdiction
regulatory authority
governmental agency or office assigned to oversee the regulation of a regulated product within a country,
jurisdiction, or assigned territory
[SOURCE: ISO 16142-1:2016, 3.1]
3.5
benefit
positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive
impact on patient management or public health
Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related
to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.
[SOURCE: ISO 14971:2019, 3.2]
ISO 18562-1:2024(en)
3.6
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 benefit provided.
[SOURCE: ISO 10993-1:2018, 3.1, modified — added accessory and note.]
3.7
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a medical device or accessory is safe
and performs as intended
[SOURCE: ISO 16142-1:2016, 3.3, modified — added ‘or accessory’.]
3.8
expected lifetime
expected service life
period specified by the manufacturer during which the medical device or accessory is expected to maintain
basic safety and essential performance
Note 1 to entry: The expected lifetime can be affected by the stability of the medical device or accessory or by the
materials in the medical device or accessory.
Note 2 to entry: Maintenance, repairs or upgrades (e.g., safety or security modifications) can be necessary during the
expected lifetime.
Note 3 to entry: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g., software)
have a relative lifetime (e.g., the time be
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