ISO 18562-3:2024
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
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.
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
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.
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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
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ISO 18562-3:2024(en)
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© 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
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
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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
© ISO 2024 – All rights reserved
iii
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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 normall
...
Norme
internationale
ISO 18562-3
Deuxième édition
Évaluation de la biocompatibilité
2024-03
des chemins de gaz respiratoire
utilisés dans le domaine de la
santé —
Partie 3:
Essais concernant les émissions de
substances organiques volatiles
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 3: Tests for emissions of volatile organic substances
Numéro de référence
ISO 18562-3:2024(fr) © ISO 2024
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ISO 18562-3:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
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© ISO 2024 – Tous droits réservés
ii
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ISO 18562-3:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Principes généraux . 2
5 Émissions de matières particulaires . 3
5.1 Généralités .3
5.2 Méthode d’essai .3
5.3 Évaluation de la dose d’inhalation .7
6 Rapport . 8
Annexe A (informative) Justification et recommandations .10
Annexe B (informative) Référence aux principes essentiels et aux recommandations d’étiquetage
de l’IMDRF .13
Annexe C (informative) Référence aux principes essentiels . 14
Annexe D (informative) Terminologie — Index alphabétique des termes définis .15
Bibliographie .16
© ISO 2024 – Tous droits réservés
iii
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ISO 18562-3:2024(fr)
Avant-propos
L’
...
FINAL DRAFT
International
Standard
ISO/FDIS 18562-3
ISO/TC 121/SC 3
Biocompatibility evaluation
Secretariat: ANSI
of breathing gas pathways in
Voting begins on:
healthcare applications —
2023-12-20
Part 3:
Voting terminates on:
2024-02-14
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 18562-3:2023(en) © ISO 2023
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ISO/FDIS 18562-3:2023(en)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18562-3
ISO/TC 121/SC 3
Biocompatibility evaluation of
Secretariat: ANSI
breathing gas pathways in healthcare
Voting begins on:
applications —
Voting terminates on:
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
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
ISO/CEN PARALLEL PROCESSING
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO
CP 401 • Ch. de Blandonnet 8
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
CH-1214 Vernier, Geneva
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
Phone: +41 22 749 01 11
DOCUMENTATION.
Email: copyright@iso.org
IN ADDITION TO THEIR EVALUATION AS
Website: www.iso.org Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 18562-3:2023(E)
Published in Switzerland
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
© ISO 2023 – All rights reserved
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
ii
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ISO/FDIS 18562-3:2023(E)
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 .
...
ISO/FDIS 18562-3
ISO/TC 121/SC 3
Secretariat: ANSI
Date: 2023-11-2712-05
Biocompatibility evaluation 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
FDIS stage
© ISO 2023 – All rights reserved
---------------------- Page: 1 ----------------------
ISO/FDIS 18562-3:2023(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
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 18562-3:2023(E)
© ISO 2023 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 18562-3:2023(E)
Contents
Foreword . v
Introduction . vi
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 . 10
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances . 13
Annex C (informative) Reference to the essential principles . 14
Annex D (informative) Terminology — Alphabetized index of defined terms . 15
Bibliography . 20
iv © ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 18562-3:2023(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.
...
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