EN ISO 18562-3:2024
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
This document specifies tests for the emissions of volatile organic substances from 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 tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.
NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds.
This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. 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 devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such 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.
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 series.
This document is intended to be read in conjunction with ISO 18562-1.
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs) (ISO 18562-3:2024)
Dieses Dokument legt Prüfungen für die Emission von flüchtigen organischen Substanzen aus den Gaswegen eines Medizinprodukts sowie von dessen Teilen oder Zubehör fest, die für die Beatmung oder die Zufuhr von Stoffen über die Atemwege zu Patienten in allen Umgebungen vorgesehen sind. Die Prüfungen in diesem Dokument dienen dazu, die Emissionen von flüchtigen organischen Substanzen, die dem Atemgasstrom durch die Werkstoffe des Gaswegs hinzugefügt werden, zu messen. Dieses Dokument erstellt Akzeptanzkriterien für diese Prüfungen.
ANMERKUNG Gasförmige Emissionen flüchtiger organischer Substanzen umfassen Emissionen von flüchtigen organischen Verbindungen, schwer flüchtigen organischen Verbindungen und leicht flüchtigen organischen Verbindungen.
Dieses Dokument behandelt die potenzielle Verunreinigung des Gasstroms aus den Gaswegen von Medizinprodukten oder Zubehör, die anschließend dem Patienten zugeführt wird.
Dieses Dokument ist anwendbar für die zu erwartete Lebensdauer des Medizinprodukts bei bestimmungsgemäßem Gebrauch und berücksichtigt die Auswirkungen jeder beabsichtigten Aufbereitung.
Dieses Dokument behandelt nicht die biologische Beurteilung der Oberflächen von Gaswegen in direktem Kontakt mit dem Patienten. Die Anforderungen an Oberflächen in direktem Kontakt sind in der Normenreihe ISO 10993 enthalten.
Medizinprodukte, Teile oder Zubehör, die Gaswege enthalten, die in diesem Dokument behandelt werden, umfassen unter anderem Beatmungsgeräte, Anästhesie-Arbeitsplätze (einschließlich Gasmischern), Atemsysteme, Sauerstoff-Dosiersysteme, Sauerstoff-Konzentratoren, Vernebler, Niederdruck-Schlauchsysteme, Anfeuchter, Wärme- und Feuchtigkeitsaustauscher, Atemgas-Überwachungsgeräte, Atmungsüberwachungsgeräte, Masken, medizinische persönliche Atemschutzausrüstung, Mundstücke, Wiederbelebungsgeräte, Atemschläuche, Atemsystemfilter, Y-Stücke und jedes für den Einsatz mit Geräten vorgesehene Atemzubehör. Die umschlossene Kammer eines Inkubators einschließlich der Matratze und der inneren Oberfläche einer Sauerstoffhaube gelten als Gaswege und werden ebenfalls in diesem Dokument behandelt.
Dieses Dokument behandelt nicht die bereits in dem aus der Gasquelle zugeführten Gas vorhandene Verunreinigung während des bestimmungsgemäßen Gebrauchs von Medizinprodukten.
BEISPIEL In das Medizinprodukt eintretende Verunreinigungen aus den Gasquellen wie etwa Rohrleitungssystemen für medizinische Gase (einschließlich Rückschlagventilen in den Leitungsauslässen), Ausgänge von Druckminderen, die mit Flaschen für medizinische Gase verbunden oder in diese integriert sind, oder in das Medizinprodukt eintretende Raumluft werden nicht in der Normenserie ISO 18562 behandelt.
Dieses Dokument ist zur Verwendung in Verbindung mit ISO 18562 1 vorgesehen.
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la santé - Partie 3: Essais concernant les émissions de substances organiques volatiles (ISO 18562-3:2024)
Le présent document spécifie les essais concernant les émissions de substances organiques volatiles provenant des chemins de gaz utilisés dans un dispositif médical, ses parties ou ses accessoires, qui sont destinés à dispenser des soins respiratoires ou à fournir des substances par les voies respiratoires à un patient dans tous les types d’environnements. Les essais du présent document sont destinés à quantifier les émissions de substances organiques volatiles ajoutées au flux de gaz respirable par les matériaux du chemin de gaz. Le présent document établit les critères d’acceptation de ces essais.
NOTE L’émission gazeuse de substances organiques volatiles comprennent les émissions de composés organiques volatils, de composés organiques semi-volatils et de composés organiques très volatils.
Le présent document traite de la contamination potentielle du flux gazeux qui provient des chemins de gaz de dispositifs médicaux ou d’accessoires et qui est ensuite acheminé jusqu’au patient.
Le présent document s’applique tout au long de la durée de vie prévue du dispositif médical en utilisation normale et prend en compte les effets associés à tout traitement prévu.
Le présent document ne traite pas de l’évaluation biologique des surfaces des chemins de gaz qui sont en contact direct avec le patient. Les exigences relatives aux surfaces en contact direct sont indiquées dans la série de normes ISO 10993.
Les dispositifs médicaux, leurs parties ou accessoires, contenant des chemins de gaz et faisant l’objet du présent document, comprennent, mais sans s’y limiter, les ventilateurs, les systèmes d’anesthésie (y compris les mélangeurs de gaz), les systèmes respiratoires, les économiseurs d’oxygène, les concentrateurs d’oxygène, les nébuliseurs, les flexibles de raccordement à basse pression, les humidificateurs, les échangeurs de chaleur et d’humidité, les moniteurs de gaz respiratoires, les moniteurs de respiration, les masques, les embouts buccaux, les appareils de réanimation, les tubes respiratoires, les filtres des systèmes respiratoires, les raccords en Y ainsi que tous les accessoires respiratoires destinés à être utilisés avec ces dispositifs médicaux. La chambre fermée d’un incubateur, y compris le matelas et la surface intérieure d’une cloche de Hood, est considérée comme un chemin de gaz et est également couverte par le présent document.
Le présent document ne traite pas de la contamination déjà présente dans le gaz provenant des sources de gaz lors d’une utilisation normale des dispositifs médicaux.
EXEMPLE La contamination arrivant dans le dispositif médical et provenant de sources de gaz, telles que des systèmes de distribution de gaz médicaux (notamment les clapets antiretour situés sur les prises murales), les sorties des détendeurs raccordés ou intégrés à une bouteille de gaz médical, ou l’air ambiant envoyé dans le dispositif médical, ne sont pas couverts par la série de normes ISO 18562.
Le présent document a pour vocation d’être lu conjointement avec l’ISO 18562-1.
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 3. del: Preskusi emisij hlapnih organskih spojin (VOC) (ISO 18562-3:2024)
Ta dokument določa preskuse emisij hlapnih organskih spojin (VOC) iz poti plinov medicinskega pripomočka, njegovih delov ali dodatne opreme, namenjene za oskrbo dihal ali dovajanje snovi prek dihalnega trakta pacientu v vseh okoljih. Namen preskusov v tem dokumentu je določiti emisije hlapnih organskih spojin, ki se dodajo toku dihalnega plina prek materialov poti plinov. Ta dokument določa merila sprejemljivosti za te preskuse.
OPOMBA: Plinske emisije hlapnih organskih spojin vključujejo emisije hlapnih organskih spojin, polhlapnih organskih spojin in zelo hlapnih organskih spojin.
Dokument obravnava možnost kontaminacije toka plinov, ki izhaja iz poti plinov medicinskih pripomočkov ali dodatne opreme in se nato prenese v pacienta.
Dokument se uporablja med pričakovano življenjsko dobo medicinskega pripomočka pri normalni uporabi in upošteva učinke predvidene obdelave.
Ta dokument ne obravnava biološkega vrednotenja površin poti plinov, ki so v neposrednem stiku s pacientom. Zahteve za neposredne kontaktne površine so podane v skupini standardov ISO 10993.
Medicinski pripomočki, njihovi deli in dodatna oprema, ki vključujejo poti plinov, obravnavane v tem dokumentu, med drugim zajemajo ventilatorje, delovna mesta za anestezijo (vključno z mešalniki plinov), sisteme za vdihavanje, pripomočke za shranjevanje kisika, naprave za koncentriranje kisika, nebulatorje, nizkotlačne povezovalne cevi, vlažilnike zraka, izmenjevalnike toplote in vlage, monitorje dihalnih plinov, respiratorje, maske, medicinsko respiratorno osebno varovalno opremo, ustne nastavke, naprave za oživljanje, cevke za dihanje, filtre dihalnih sistemov, razdelilne elemente v obliki črke Y in katero koli dodatno opremo za dihanje, ki je namenjena za uporabo s takšnimi pripomočki. Zaprta komora inkubatorja, vključno z žimnico, in notranja površina kisikovega pokrova se štejeta za poti plinov ter sta prav tako obravnavani v tem dokumentu.
Ta dokument ne obravnava že prisotne kontaminacije v plinu, ki se dovaja iz virov plina med normalno uporabo medicinskih pripomočkov.
PRIMER: Kontaminacija, ki se prenese v medicinski pripomoček iz virov plina, kot so sistemi napeljav za medicinske pline (vključno z nepovratnimi ventili v odvodih cevi), odvodi regulatorjev tlaka, ki so povezani z jeklenko medicinskega plina oziroma so del nje, ali zrak v prostoru, ki vstopi v medicinski pripomoček, ni obravnavana v skupini standardov ISO 18562.
Ta dokument je treba uporabljati v povezavi s standardom ISO 18562-1.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 18562-3:2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 3. del:
Preskusi emisij hlapnih organskih spojin (VOC) (ISO 18562-3:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3:
Tests for emissions of volatile organic substances (ISO 18562-3:2024)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs) (ISO
18562-3:2024)
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le
domaine de la santé - Partie 3: Essais concernant les émissions de substances
organiques volatiles (ISO 18562-3:2024)
Ta slovenski standard je istoveten z: EN ISO 18562-3:2024
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 18562-3
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18562-3:2020
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 3: Tests for emissions of
volatile organic substances (ISO 18562-3:2024)
Évaluation de la biocompatibilité des chemins de gaz Beurteilung der Biokompatibilität der Atemgaswege
respiratoire utilisés dans le domaine de la santé - bei medizinischen Anwendungen - Teil3: Prüfungen für
Partie 3: Essais concernant les émissions de substances Emissionen von flüchtigen organischen Verbindungen
organiques volatiles (ISO 18562-3:2024) (VOCs) (ISO 18562-3:2024)
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 18562-3:2024 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 18562-3:2024) 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 18562-3:2020.
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 18562-3:2024 has been approved by CEN as EN ISO 18562-3:2024 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
Performance Requirements Clause(s) / sub-clause(s)
Remarks / Notes
of Regulation (EU) of this EN
2017/745
10.1 a) Clause 4, Clause 5 This requirement is only partly
covered by this document, since the
standard does not provide
requirements on manufacture.
However, this standard provides a
means to assess toxicity of volatile
organic 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 This requirement is only partly
covered by this document, since the
standard does not provide
requirements on manufacture.
However, this standard provides a
means to assess toxicity of volatile
organic substances added by the
medical device to the gas pathways of
manufactured medical devices.
10.2 Clause 4, Clause 5 This requirement is only partly
covered by this document, since the
standard 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
volatile organic substances added by
the medical device to the gas pathways
of manufactured medical devices.
It is within the scope to address the
potential contamination generated
from the original manufacturing
process or generated by the medical
device itself during use. Packaging is
not covered. Risks to other persons
involved in the transport, storage and
use are not covered.
General Safety and
Performance Requirements Clause(s) / sub-clause(s)
Remarks / Notes
of Regulation (EU) of this EN
2017/745
10.4.1 (first paragraph only) Clause 4, Clause 5 This requirement is only partly
covered by this document, since the
standard does not provide
requirements on manufacture.
However, this standard provides a
means to assess risks to the patient
associated with the toxicity of volatile
organic substances added by the
medical device to the gas pathways of
manufactured medical devices. Other
forms of toxicity are not covered. Risks
from substances or particles released
from the device outside of the gas
pathways 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 16000-3:2022 ISO 16000-3:2022 Indoor air — Part 3: —
Determination of
formaldehyde and other
carbonyl compounds in
indoor and test chamber
air — Active sampling
method
ISO 16000-4:2011 ISO 16000-4:2011 Indoor air — Part 4: —
Determination of
formaldehyde — Diffusive
sampling method
ISO 18562-1:2024 ISO 18562-1:2024 Biocompatibility EN ISO 18562-1:2024
evaluation of breathing gas
pathways in healthcare
applications — Part 1:
Evaluation and testing
within a risk management
process
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- 2017/745 that
clause defines or uses this
where term
this term
is
defined
in this EN
N/A N/A N/A No legally relevant terms are defined in this Standard
International
Standard
ISO 18562-3
Second edition
Biocompatibility evaluation
2024-03
of breathing gas pathways in
healthcare applications —
Part 3:
Tests for emissions of volatile
organic substances
Évaluation de la biocompatibilité des chemins de gaz respiratoire
utilisés dans le domaine de la santé —
Partie 3: Essais concernant les émissions de substances
organiques volatiles
Reference number
ISO 18562-3:2024(en) © ISO 2024
ISO 18562-3:2024(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 18562-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles . 2
5 Volatile organic substance emissions . . 2
5.1 General .3
5.2 Test method .3
5.3 Assessment of inhalation dose .7
6 Reporting . 8
Annex A (informative) Rationale and guidance . 9
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .12
Annex C (informative) Reference to the essential principles .13
Annex D (informative) Terminology — Alphabetized index of defined terms. 14
Bibliography .15
iii
ISO 18562-3:2024(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 18562-3:2017), 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;
— broke the term VOC (now VOS) into parts based on boiling point.
A list of all parts of 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 18562-3:2024(en)
Introduction
This document is intended to protect patients connected to medical devices from excessive amounts of
volatile organic substances that arise from within the gas pathways of those medical devices. This document
represents the application of the best-known science by addressing the risks from potentially hazardous
volatile organic 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 appropriately address the biological evaluation of the gas pathways of medical
devices. For example, the ISO 10993 series does not provide guidance how to evaluate the presence of VOSs.
It is not within the scope of this document to address contamination arising from the source of the breathing
gases entering such medical devices, but rather only address the potential contamination generated from
within the medical device itself. This contamination might be from the original manufacturing process or
generated by the medical device itself during use.
This document is concerned with volatile organic substances that could be conveyed to the patient by the
breathing gases. Volatile organic substances can have health effects ranging from unpleasant odour and
irritation of the mucous membranes to possible long-term effects on the nervous system. It is accepted that
there is no point in setting levels that are lower than those found in air that people might breathe every day.
The tests for the presence of volatile organic substances generated by respiratory medical devices are based
on advanced laboratory practice and require specialist training and equipment to generate meaningful
results.
The methods to determine the acceptable levels of contamination are contained in ISO 18562-1.
This document has been prepared in consideration of:
— the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/
[7]
GRRP WG/N47:2018 as indicated in Annex B;
[8]
— the Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N52:2019 as
indicated in Annex B;
— the the essential principles of safety and performance 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
[9]
(EU) 2017/745 .
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.
v
International Standard ISO 18562-3:2024(en)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 3:
Tests for emissions of volatile organic substances
1 Scope
This document specifies tests for the emissions of volatile organic substances from 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 tests of this document are intended to quantify
emissions of volatile organic substances that are added to the respirable gas stream by the materials of the
gas pathway. This document establishes acceptance criteria for these tests.
NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-
volatile organic compounds and very volatile organic compounds.
This document addresses potential contamination of the gas stream arising from the gas pathways of medical
devices or accessories, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account
the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that are in direct
contact with the patient. 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 devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers,
heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory
personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters,
Y-pieces and any breathing accessories intended to be used with such 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.
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 series.
This document is intended to be read in conjunction with ISO 18562-1.
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 16000-3:2022, Indoor air — Part 3: Determination of formaldehyde and other carbonyl compounds in indoor
and test chamber air — Active sampling method
ISO 18562-3:2024(en)
ISO 16000-4:2011, Indoor air — Part 4: Determination of formaldehyde — Diffusive sampling method
ISO 16000-6:2021, Indoor air — Part 6: Determination of organic compounds (VVOC, VOC, SVOC) in indoor and
test chamber air by active sampling on sorbent tubes, thermal desorption and gas chromatography using MS or
MS FID
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18562-1:2024 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, an alphabetized index of all defined terms and their sources used in this document are
given in Annex D.
3.1
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.97]
3.2
target compounds
compounds that are believed likely to be present and therefore need to be deliberately looked for
3.3
thermal stability
condition under which the temperature of an object does not change by more than 2 °C over a period of 1 h
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.125, modified — “increase” has been changed to
“change”.]
4 General principles
All gas pathways of medical devices or accessories shall be evaluated using the strategy detailed in
ISO 18562-1:2024.
The fundamental consideration in assessing a substance is to determine the inhalation dose of this substance
to the patient.
Limits for toxicological purposes are most often quoted in µg/kg body mass/d (tolerable intake). Limits
for environmental purposes, and the quantity that is measured by test laboratories, are usually quoted as
3 3
concentrations in µg/m . The inhalation dose depends on the concentration of the substance (in µg/m )
multiplied by the volume inhaled by the patient in a day (in m /d).
Standard daily breathing volumes are found in ISO 18562-1:2024, 6.2.
5 Volatile organic substance emissions
NOTE There is guidance or rationale for this Clause contained in Clause A.2.
ISO 18562-3:2024(en)
5.1 General
a) All gas pathways of a medical device or accessory shall be evaluated for the emission of volatile organic
substances.
NOTE 1 Gaseous emission of volatile organic substances includes emissions of VOCs, SVOCs and VVOCs.
b) In the selection of materials to be used in the medical device manufacture, the first consideration should
be given for fitness for purpose with regard to characteristics and properties of the material, which
include physical, mechanical, chemical and toxicological properties.
1) Knowledge of materials should inform the nature and extent of screening for substances including
any target compounds.
2) Specific sampling methods may be required for target compounds.
EXAMPLE Aldehydes from polyoxymethylene plastics, isocyanates and degradation products f
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...