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/FDIS 18562-4:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18562-4:2023
01-januar-2023
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 4. del:
Preskusi izlužnin v kondenzatih (ISO/DIS 18562-4:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4:
Tests for leachables in condensate (ISO/DIS 18562-4:2022)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO/DIS 18562-4:2022)
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications
de soins de santé - Partie 4: Essais concernant les substances relargables dans le
condensat (ISO/DIS 18562-4:2022)
Ta slovenski standard je istoveten z: prEN ISO 18562-4
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18562-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 18562-4:2023
oSIST prEN ISO 18562-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-4
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 4:
Tests for leachables in condensate
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 4: Essais concernant les substances relargables dans le condensat
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
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oSIST prEN ISO 18562-4:2023
ISO/DIS 18562-4:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-4
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 4:
Tests for leachables in condensate
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 4: Essais concernant les substances relargables dans le condensat
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
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NATIONAL REGULATIONS.
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 18562-4:2023
ISO/DIS 18562-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles . 3
4.1 Type tests . 3
4.2 General . 3
5 Leachables in condensate . 3
5.1 Identifying applicable gas pathway surfaces . 3
5.2 Determining if testing is required . 3
5.3 Test methods . 4
5.3.1 General . 4
5.3.2 Sample collection . 5
5.3.3 Chemical characterization of leachables in condensate. 6
5.3.4 Calculation of tolerable exposure . 7
5.3.5 Calculation of exposure dose estimate . 7
5.3.6 Risk assessment . 7
5.3.7 Biological evaluation according to ISO 10993 standards . 8
6 Reporting . 9
Annex A (informative) Rationale and guidance .10
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .12
Annex C (informative) Reference to the essential principles .13
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .14
Bibliography .17
Terminology — Alphabetized index of defined terms .19
iii
oSIST prEN ISO 18562-4:2023
ISO/DIS 18562-4:2022(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 of the voluntary nature of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care 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 cancels and replaces the first edition (ISO 18562-4:2017), which has been
technically revised. 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;
— clarified the stepwise test procedure;
— required determination of volume of condensate that can reach the patient; and
— required calculating resulting exposure dose.
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 18562-4:2023
ISO/DIS 18562-4:2022(E)
Introduction
This document is intended to protect patients connected to medical devices from harmful amounts of
substances that might be dissolved in water that has condensed in the gas pathways of those medical
devices. This document represents the application of the best-known science by addressing the risks
from potentially hazardous substances in the condensate being conveyed to the patient by the gas
pathway. The condensate itself will be distilled water, having condensed from the vapour phase. But
substances from within the medical device could leach into the liquid water (condensate) present in the
breathing system.
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.
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.
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 substances that could be conveyed to the patient by liquid condensate
forming in the medical device and then subsequently reaching the lungs
...
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