EN 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 - Teil3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs) (ISO 18562-3:2024)

Dieses Dokument legt Prüfungen für die Emission von flüchtigen organischen Verbindungen 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 Verbindungen, die dem Atemgasstrom durch die Werkstoffe des Gaswegs hinzugefügt werden, zu messen. Dieses Dokument erstellt Akzeptanzkriterien für diese Prüfungen.
ANMERKUNG   Gasförmige Emissionen flüchtiger organischer Verbindungen 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/FDIS 18562-3:2023)

General Information

• Status: Published
• Publication Date: 22-Oct-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Oct-2024
• Completion Date: 23-Oct-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: kSIST FprEN ISO 18562-3:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO/FDIS 18562-3:2023)

Relations

• Replaces: EN ISO 18562-3:2020 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017)
• Effective Date: 21-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 18562-3:2023
01-januar-2023
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 3. del:
Preskusi emisij hlapnih organskih spojin (VOC) (ISO/DIS 18562-3:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3:
Tests for emissions of volatile organic substances (ISO/DIS 18562-3:2022)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs)
(ISO/DIS 18562-3:2022)
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications
de soins de santé - Partie 3: Essais concernant les émissions de substances organiques
volatils (ISO/DIS 18562-3:2022)
Ta slovenski standard je istoveten z: prEN ISO 18562-3
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18562-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 18562-3:2023
oSIST prEN ISO 18562-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-3
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-03 2023-01-26
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 respiratoires dans les applications de soins de
santé —
Partie 3: Essais concernant les émissions de substances organiques volatils
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18562-3:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

oSIST prEN ISO 18562-3:2023
ISO/DIS 18562-3:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-3
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:

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 respiratoires dans les applications de soins de
santé —
Partie 3: Essais concernant les émissions de substances organiques volatils
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 18562-3:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

oSIST prEN ISO 18562-3:2023
ISO/DIS 18562-3:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles . 2
4.1 Type tests . 2
4.2 General . 3
5 Volatile organic substance emissions . 3
5.1 General . 3
5.2 Acceptance criteria . 3
5.3 Test method . 4
5.4 Assessment of exposure dose . 8
6 Reporting . 9
Annex A (informative) Rationale and guidance .11
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .13
Annex C (informative) Reference to the essential principles .14
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .15
Bibliography .17
Terminology — Alphabetized index of defined terms .18
iii
oSIST prEN ISO 18562-3:2023
ISO/DIS 18562-3:2022(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 on the voluntary nature of ISO 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 the following
URL: 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 of ISO 18562-3 cancels and replaces the first edition of ISO 18562-3.
The main changes compared to the previous edition are as follows:
— reformatted according to most recent Central Secretariat editing rules;
— added informative mapping annexes to relevant regulatory requirements;
— clarified terms and definitions used in the document.
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
oSIST prEN ISO 18562-3:2023
ISO/DIS 18562-3:2022(E)
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.
[1]
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 tests do not detect VOCs.
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.
In this document, the following print types are used:
— requirements and definitions: roman 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;
— terms defined in Clause 3 of this document or as noted and test specifications: italic type;
This document has been prepared in consideration of:
— the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/
[4]
GRRP WG/N47:2018 as indicated in Annex B;
[5]
— the Labelling Principles for Medical Devices and IV
...