EN ISO 18562-2:2024
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
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 18562-2:2024)
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 18562-2:2024)
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 18562-2:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 18562-2:2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del:
Preskusi emisij delcev (ISO 18562-2:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2:
Tests for emissions of particulate matter (ISO 18562-2:2024)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 2: Prüfungen für Emissionen von Partikeln (ISO 18562-2:2024)
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 18562-2:2024)
Ta slovenski standard je istoveten z: EN ISO 18562-2:2024
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 18562-2
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18562-2:2020
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 2: Tests for emissions of
particulate matter (ISO 18562-2:2024)
Évaluation de la biocompatibilité des chemins de gaz Beurteilung der Biokompatibilität der Atemgaswege
respiratoire utilisés dans le domaine de la santé - bei medizinischen Anwendungen - Teil 2: Prüfungen
Partie 2: Essais concernant les émissions de matières für Emissionen von Partikeln (ISO 18562-2:2024)
particulaires (ISO 18562-2:2024)
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 18562-2:2024 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 18562-2:2024) 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 18562-2:2020.
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 18562-2:2024 has been approved by CEN as EN ISO 18562-2:2024 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
Clause(s) / sub-clause(s)
Requirements of Regulation (EU) Remarks / Notes
of this EN
2017/745
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
inhalation of a total quantity of
particulates with diameters 0,25 μm
to 10 μm emitted by the gas
pathways of manufactured medical
devices.
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 inhalation of a
total quantity of particulates with
diameters 0,25 μm to 10 μm
emitted by 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.
10.6 (first sentence) 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 inhalation of a
total quantity of particulates with
diameters 0,25 μm to 10 μm
emitted by the gas pathways of
manufactured medical devices.
Risks to the user and other persons
(if they are not the patient) are not
covered. Risks related to
nanomaterials 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 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 18562-2
Second edition
Biocompatibility evaluation
2024-03
of breathing gas pathways in
healthcare applications —
Part 2:
Tests for emissions of particulate
matter
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
Reference number
ISO 18562-2:2024(en) © ISO 2024
ISO 18562-2:2024(en)
© ISO 2024
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Published in Switzerland
ii
ISO 18562-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...
Questions, Comments and Discussion
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