FprEN ISO 18562-2
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO/FDIS 18562-2:2023)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO/FDIS 18562-2:2023)
This document specifies tests for the emissions of particulate matter 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 particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests.
This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter.
This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction.
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
This document addresses potential contamination of the gas stream arising from the gas pathways, 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 particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).
This document does not address biological evaluation of the surfaces of gas pathways that have 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 (all parts).
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 2: Prüfungen für Emissionen von Partikeln (ISO/FDIS 18562-2:2023)
ANMERKUNG Abschnitt A.2 enthält eine Anleitung oder Begründung zu diesem Abschnitt.
Dieses Dokument legt Prüfungen für die Emissionen von Partikeln aus den Gaswegen eines Medizinprodukts sowie von dessen Teilen oder Zubehör fest, die für die Beatmung oder die Zufuhr von Stoffen über die Atemwege zum Patienten in allen Umgebungen vorgesehen sind. Die Prüfungen in diesem Dokument dienen dazu, Partikel mit einem Durchmesser von 0,25 µm bis 10 µm, die von einem Medizinprodukt, dessen Teilen oder Zubehör in den atembaren Gasstrom abgegeben werden, zu quantifizieren. Dieses Dokument erstellt Akzeptanzkriterien für diese Prüfungen.
Dieses Dokument behandelt keine Nanopartikel. Für die Festlegung der Expositionsgrenzwerte für Partikel mit einem Durchmesser von weniger als 0,25 µm stehen keine ausreichenden Daten zur Verfügung.
In diesem Dokument werden keine Partikel abgedeckt, deren Durchmesser mehr als 10 µm beträgt. Diese Partikel werden in der Nasenhöhle abgesetzt. Zusätzliche Informationen können erforderlich werden für ein Medizinprodukt oder Zubehör, das die Nase umgeht. Dies liegt außerhalb des Anwendungsbereichs dieses Dokuments, kann aber von einigen zuständigen Behörden angefordert werden.
Dieses Dokument wendet daher denselben Ansatz wie die US Environmental Protection Agency (EPA) an, die Grenzwerte, ausschließlich auf Basis der Partikelgröße und nicht ihrer chemischen Zusammensetzung festlegt.
Dieses Dokument behandelt die potenzielle Verunreinigung des Gasstroms aus den Gaswegen, 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 Partikel, die absichtlich von einem Vernebler freigesetzt werden (d. h. das Therapeutikum).
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 an den Leitungsauslässen), Ausgänge von Druckminderern, die mit Flaschen für medizinische Gase verbunden oder in diese integriert sind, oder in das Medizinprodukt eintretende Raumluft werden nicht in ISO 18562 (alle Teile) behandelt.
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la santé - Partie 2: Essais concernant les émissions de matières particulaires (ISO/FDIS 18562-2:2023)
Le présent document spécifie les essais concernant les émissions des matières particulaires 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 contenus dans le présent document sont destinés quantifier les particules dont le diamètre est compris entre 0,25 µm et 10 µm et qui sont émises par le dispositif médical, ses parties ou ses accessoires dans le flux de gaz respirable. Le présent document établit les critères d’acceptation de ces essais.
Le présent document ne traite pas des nanoparticules. Il n’existe pas de données suffisantes afin d’établir des limites d’exposition pour les particules d’un diamètre inférieur à 0,25 µm.
Le présent document ne traite pas des particules d’un diamètre supérieur à 10 µm. Ces particules se déposent dans la cavité nasale. Des informations supplémentaires peuvent se révéler nécessaires pour les dispositifs médicaux ou les accessoires qui ne passent pas par le nez. Ce point est en dehors du domaine d’application du présent document, mais il peut être requis par certaines autorités compétentes.
Le présent document adopte donc la même approche que l’US Environmental Protection Agency (EPA) (Agence américaine de protection de l’environnement) en établissant des limites fondées uniquement sur la taille des particules et non pas sur leurs propriétés chimiques.
Le présent document traite de la contamination potentielle du flux gazeux qui provient des chemins de gaz 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 n’aborde pas l’évaluation biologique des particules qui sont intentionnellement libérées par un nébuliseur (c’est-à-dire l’agent thérapeutique).
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 équipements médicaux de protection respiratoire individuelle, 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. 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
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del: Preskusi emisij delcev (ISO/FDIS 18562-2:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18562-2:2023
01-januar-2023
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del:
Preskusi emisij delcev (ISO/DIS 18562-2:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2:
Tests for emissions of particulate matter (ISO/DIS 18562-2:2022)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 2: Prüfungen für Emissionen von Partikeln (ISO/DIS 18562-2:2022)
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications
de soins de santé - Partie 2: Essais concernant les émissions de matières particulaires
(ISO/DIS 18562-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 18562-2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18562-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 18562-2:2023
oSIST prEN ISO 18562-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-2
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-04 2023-01-27
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 2:
Tests for emissions of particulate matter
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 2: Essais concernant les émissions de matières particulaires
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 18562-2:2022(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 18562-2:2023
ISO/DIS 18562-2:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-2
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 2:
Tests for emissions of particulate matter
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 2: Essais concernant les émissions de matières particulaires
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: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 18562-2:2022(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 18562-2:2023
ISO/DIS 18562-2:2022(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 . 2
5 Particulate matter emissions . 3
5.1 General . 3
5.2 Testing methods overview . 3
5.3 Single filter test setup . 4
5.4 Double filter test setup . 5
5.5 Test method . 6
5.6 Measuring particulate matter emissions according to particle size . 7
5.7 Measuring particulate matter emissions by particle counter. 7
5.8 Medical devices with time-varying emissions . 7
6 Reporting . 7
Annex A (informative) Rationale and guidance . 9
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 18562-2:2023
ISO/DIS 18562-2:2022(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 18562-2 cancels and replaces the first edition of ISO 18562-2.
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 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
oSIST prEN ISO 18562-2:2023
ISO/DIS 18562-2:2022(E)
Introduction
This document is intended to protect patients connected to medical devices from excessive amounts of
particulate matter that arises from within gas pathways of medical devices.
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.
[2]
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 evaluate inspired particulate
matter.
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 to address only the potential contamination
generated from within the medical device itself. This contamination might be from the original
manufacturing process or be generated by the medical device itself during use.
This document is concerned with particulate matter that could be conveyed to the patient by the
breathing gases. The smaller the particle, the deeper into the lungs it can penetrate and the longer it
takes the body to eliminate it. Originally, the main health concerns with regard to particulate matter
were focused on respiratory health, but now there is emerging evidence of effects on the cardiovascular
system as well.
The tests for the presence of particulate matter generated by respiratory medical devices are based on
standard laboratory practice and require no advanced techniques or equipment.
The acceptable levels of contamination are based on worldwide published health data for particulates.
It is accepted that there is no point in setting a level that is lower than that found in air that people
might breathe every day of their lives.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such a
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.