EN ISO 18562-4:2024
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
This document specifies tests for substances leached by liquid water condensing in 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 chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.
This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas 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 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.
This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO 18562-4:2024)
Dieses Dokument legt Prüfungen für Substanzen fest, die durch flüssiges Wasser herausgelöst werden und in dem Kondensat enthalten sind, das sich in den Gaswegen eines Medizinprodukts sowie von dessen Teilen oder Zubehör, die für die Beatmung oder die Zufuhr von Stoffen über die Atemwege zu Patienten in allen Umgebungen vorgesehen sind, bildet. Die in diesem Dokument beschriebenen Verfahren zur chemischen Charakterisierung gelten für chemische Substanzen, die aus dem Medizinprodukt, seinen Teilen oder seinem Zubehör in das Kondensat gelangen könnten. Dieses Dokument erstellt verifizierbare Akzeptanzkriterien für diese Prüfungen. Die Identität und Menge jeder freigesetzten Chemikalie ist für die toxikologische Risikobeurteilung vorgesehen, wie in ISO 18562 1:— beschrieben.
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 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.
Dieses Dokument behandelt nicht den Kontakt mit Medikamenten oder Anästhesiemitteln. Wenn ein Medizinprodukt oder Zubehör für den Einsatz mit Anästhesiemitteln oder Medikamenten vorgesehen ist, können zusätzliche Prüfungen erforderlich sein. Dieses Dokument dient dazu, gefahrbringende wasserlösliche Stoffe zu quantifizieren, die aus dem Medizinprodukt, seinen Teilen oder seinem Zubehör durch Kondensat herausgelöst und anschließend durch diese Flüssigkeit dem Patienten zugeführt werden können.
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la santé - Partie 4: Essais concernant les relargables dans le condensat (ISO 18562-4:2024)
Le présent document spécifie les essais concernant les substances relarguées par l’eau liquide qui se condense dans les chemins de gaz utilisés dans un dispositif médical, ses parties ou ses accessoires, 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 méthodes de caractérisation chimique décrites dans le présent document s’appliquent aux substances chimiques qui pourraient être relarguées du dispositif médical, de ses parties ou de ses accessoires dans le condensat. Le présent document établit des critères d’acceptation vérifiables de ces essais. L’identité et la quantité de chaque substance chimique libérée sont destinées à l’appréciation du risque toxicologique, tel que d’écrit dans l’ISO 18562-1:2024.
Le présent document traite de la contamination potentielle du flux gazeux provenant des chemins de gaz, qui délivrent du gaz respiratoire 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.
Le présent document ne traite pas du contact avec les médicaments ou les agents anesthésiques. Si un dispositif médical ou un accessoire est destiné à être utilisé avec des agents anesthésiants ou des médicaments, des essais supplémentaires peuvent être requis. Le présent document est destiné à quantifier les substances dangereuses solubles dans l’eau qui sont relarguées du dispositif médical, ses parties ou ses accessoires par un condensat et qui sont ensuite acheminées par ce liquide jusqu’au patient.
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 4. del: Preskusi izlužnin v kondenzatih (ISO 18562-4:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 18562-4:2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 4. del:
Preskusi izlužnin v kondenzatih (ISO 18562-4:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4:
Tests for leachables in condensate (ISO 18562-4:2024)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO 18562-4:2024)
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le
domaine de la santé - Partie 4: Essais concernant les relargables dans le condensat
(ISO 18562-4:2024)
Ta slovenski standard je istoveten z: EN ISO 18562-4:2024
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 18562-4
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18562-4:2020
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 4: Tests for leachables in
condensate (ISO 18562-4:2024)
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 4: Prüfungen
Partie 4: Essais concernant les relargables dans le für herauslösbare Substanzen in Kondensaten (ISO
condensat (ISO 18562-4:2024) 18562-4:2024)
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 18562-4:2024 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 18562-4:2024) 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 18562-4:2020.
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 18562-4:2024 has been approved by CEN as EN ISO 18562-4:2024 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
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
10.1 a) Clause 4, Clause 5, Clause 6 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 the
condensate from the gas pathways of
manufactured medical devices. Other
forms of toxicity and flammability are
not covered.
10.1 b) Clause 4, Clause 5, Clause 6 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 the
condensate from the gas pathways of
manufactured medical devices.
10.2 Clause 4, Clause 5, Clause 6 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 the condensate from the
gas pathways of manufactured
medical devices. Risks to other
persons involved in the transport,
storage and use of the devices are not
covered.
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
10.3 Clause 4, Clause 5, Clause 6 This requirement is only partly
covered by this document, since the
standard does not provide
requirements on manufacture. Only
the aspects relating to contamination
of the gas pathways by contact with
water are covered.
Risks to the patient associated with
medicinal substances added to the
gas stream are not covered.
10.4.1 (first paragraph only) Clause 4, Clause 5, Clause 6 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 the
condensate from the gas pathways of
manufactured medical devices. Other
forms of toxicity are not covered.
14.2 c) Clause 4, Clause 5, Clause 6 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 the
condensate from the gas pathways of
manufactured medical devices.
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 Standard
Title Corresponding European
Clause 2 Edition
Standard Edition
ISO 10993 1:2018 ISO 10993 1:2018 Biological evaluation of EN ISO 10993 1:2020
medical devices — Part 1:
Evaluation and testing
within a risk management
process
ISO 10993-5:2009 ISO 10993-5:2009 Biological evaluation of EN ISO 10993-5:2009
medical devices — Part 5:
Tests for in vitro
cytotoxicity
ISO 10993-10:2021 ISO 10993-10:2021 Biological evaluation of EN ISO 10993-10:2023
medical devices — Part
10: Tests for skin
sensitization
ISO 10993-12:2021 ISO 10993-12:2021 Biological evaluation of EN ISO 10993-12:2021
medical devices — Part
12: Sample preparation
and reference materials
ISO 10993-18:2020 ISO 10993-18:2020 Biological evaluation of EN ISO 10993-18:2020
+AMD1:2022 +AMD1:2022 medical devices — Part +A1:2023
18: Chemical
characterization of
medical device materials
within a risk management
process
ISO 10993-23:2021 ISO 10993-23:2021 Biological evaluation of EN ISO 10993-23:2021
medical devices — Part
23: Tests for irritation
a
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
ICH Q3D(R2):2022 — ICH guideline Q3D (R2) —
for elemental impurities
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
...
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