EN ISO 18562-1:2024
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
This document specifies:
— the general principles governing the biological evaluation within a risk management process of 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 general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
— the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).
This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. 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 equipment, 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 system filters and Y-pieces as well as any breathing accessories intended to be used with such medical 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 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO 18562-1:2024)
Dieses Dokument legt Folgendes fest:
- die allgemeinen Grundsätze für die biologische Bewertung in einem Risikomanagementprozess für die Gaswege eines Medizinprodukts sowie von dessen Teilen oder Zubehör, die für die Beatmung in der Pflege oder die Zufuhr von Stoffen über die Atemwege zu Patienten in allen Umgebungen vorgesehen sind;
- die allgemeine Klassifizierung von Gaswegen auf der Grundlage der Art und Dauer ihres Kontakts mit dem Gasstrom;
- die Bewertung bestehender relevanter Daten aus allen Quellen;
- die Identifizierung von Lücken in den verfügbaren Datensätzen auf der Grundlage einer Risikoanalyse;
- die Identifizierung zusätzlicher Datensätze, die für die Analyse der biologischen Sicherheit des Gaswegs erforderlich sind;
- die Beurteilung der biologischen Sicherheit des Gaswegs.
Dieses Dokument beinhaltet die allgemeinen Grundsätze der Beurteilung der Biokompatibilität von Werkstoffen von Medizinprodukten, aus denen der Gasweg bei bestimmungsgemäßem Gebrauch und im Normalzustand besteht. Dieses Dokument beinhaltet jedoch nicht biologische Gefährdungen, die durch mechanische Beschädigungen entstehen.
Die anderen Teile von ISO 18562 beinhalten spezifische Prüfungen, die potenziell gefährliche Stoffe betreffen, die dem Atemgasstrom hinzugefügt werden, und erstellen Akzeptanzkriterien für diese Stoffe.
Dieses Dokument ist vorgesehen für potenzielle Verunreinigungen des Gasstroms aus den Gaswegen innerhalb des Medizinprodukts, die anschließend dem Patienten zugeführt werden könnten.
Dieses Dokument ist anwendbar für die erwartete Lebensdauer des Medizinprodukts, wenn es entsprechend der Gebrauchsanweisung verwendet wird. Dazu gehört auch die Schädigung durch Umgebungsbedingungen sowie die Reinigung, Desinfektion und Sterilisation (d. h. die Aufbereitung). Es umfasst auch Handlungen oder unterlassene Handlungen des Anwenders, die zu einem unbeabsichtigten oder unerwarteten Ergebnis (Resultat) führen (d. h. Benutzungsfehler). Sie umfasst keine bewussten/vorsätzlichen Handlungen oder unterlassenen Handlungen, die gegen die Gebrauchsanweisung verstoßen und sich einer angemessenen Risikobeherrschung durch den Hersteller entziehen (d. h. anormaler Gebrauch).
Dieses Dokument ist nicht für die biologische Beurteilung der Oberflächen von Medizinprodukten in direktem Kontakt mit dem Patienten oder Benutzer vorgesehen. 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 [23] [25][28] [28] [29] [30] Mundstücke, Wiederbelebungsgeräte, Atemschläuche, Atemsystemfilter und Y-Stücke sowie jedes für den Einsatz mit solchen Medizinprodukten 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 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO 18562-1:2024)
Le présent document spécifie:
— les principes généraux gouvernant l’évaluation biologique au sein d’un processus de gestion du risque 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;
— la classification générale des chemins de gaz, fondée sur la nature et la durée de leur contact avec le flux gazeux;
— l’évaluation de toutes les données existantes;
— l’identification de manques dans les ensembles de données disponibles sur la base d’une analyse de risque;
— l’identification d’ensembles de données supplémentaires nécessaires à l’analyse de la sécurité biologique du chemin de gaz;
— l’évaluation de la sécurité biologique du chemin de gaz.
Le présent document couvre les principes généraux concernant l’évaluation de la biocompatibilité des matériaux des dispositifs médicaux, qui constituent le chemin de gaz, en utilisation normale et en condition normale. Le présent document ne couvre pas les phénomènes dangereux biologiques découlant de dommages mécaniques.
Les autres parties de l’ISO 18562 couvrent des essais spécifiques traitant des substances potentiellement dangereuses qui sont ajoutées au flux de gaz respirable et établissant les critères d’acceptation de ces substances.
Le présent document traite de la contamination potentielle du flux gazeux qui provient des chemins de gaz utilisés dans un dispositif médical et qui pourrait ensuite être acheminé jusqu’au patient.
Le présent document s’applique tout au long de la durée de vie prévue du dispositif médical dès lors qu’il est utilisé conformément aux instructions d’utilisation. Cela comprend toute dégradation découlant de son exposition à des conditions environnementales, ainsi qu’à son nettoyage, sa désinfection et sa stérilisation (c’est-à-dire son traitement). Cela inclut également toute action ou inaction (omission) de l’utilisation conduisant à un résultat imprévu ou inattendu (c’est-à-dire une erreur d’utilisation). En revanche, cela ne comprend pas les actions ou inactions volontaires/intentionnelles qui sont contraires aux instructions d’utilisation et dépassent la maîtrise du risque raisonnable par le fabricant (c’est-à-dire une utilisation anormale).
Le présent document ne traite pas de l’évaluation biologique des surfaces des dispositifs médicaux en contact direct avec le patient ou l’utilisateur. 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 de système respiratoire, 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 compr
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del: Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-1:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nadomešča:
SIST EN ISO 18562-1:2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-
1:2024)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO 18562-1:2024)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO
18562-1:2024)
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le
domaine de la santé - Partie 1: Évaluation et essais au sein d'un processus de gestion
du risque (ISO 18562-1:2024)
Ta slovenski standard je istoveten z: EN ISO 18562-1:2024
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 18562-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18562-1:2020
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing
within a risk management process (ISO 18562-1:2024)
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 1: Beurteilung
Partie 1: Évaluation et essais au sein d'un processus de und Prüfung innerhalb eines Risikomanagement-
gestion du risque (ISO 18562-1:2024) Prozesses (ISO 18562-1:2024)
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 18562-1:2024 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 18562-1:2024) 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 18562-1:2020.
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 18562-1:2024 has been approved by CEN as EN ISO 18562-1:2024 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
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess toxicity of
substances added by the medical device
to 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
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess toxicity of
substances added by the medical device
to the gas pathways of manufactured
medical devices.
10.2 Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 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 substances added by the
medical device to the gas pathways of
manufactured medical devices. Risks to
other persons involved in the transport,
storage and use of the devices are not
covered.
10.3 Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. Only the aspects relating to
contamination of medical gases by
contact with the gas pathways are
covered.
Risks to the patient associated with
medicinal substances added to the gas
stream are not covered.
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/745
10.4.1 (first paragraph) Clause 4, Clause 5, Clause 6, This requirement is only partly covered
Clause 7, Clause 8, Clause 9, by this document, since the standard
Clause 10, Clause 11 does not provide requirements on
manufacture. However, this standard
provides a means to assess risks to the
patient associated with the toxicity of
substances added by the medical device
to the gas pathways of manufactured
medical devices. This does not include all
aspects of degradation as these cannot be
fully evaluated using the tests of ISO
18562 alone. Other forms of toxicity 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 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- ISO 10993-17:2023 Biological evaluation of EN ISO 10993-17:2023
17:2023 medical devices — Part 17:
Toxicological risk assessment
of medical device constituents
ISO 14971:2019 ISO 14971:2019 Medical devices — Application EN ISO 14971:2019
of risk management to
EN ISO 14971:2019/A11:2021
medical devices
ISO 18562-2:2024 ISO 18562-2:2024 Biocompatibility evaluation of EN ISO 18562-2:2024
breathing gas pathways in
healthcare applications —
Part 2: Tests for emissions of
particulate matter
ISO 18562-3:2024 ISO 18562-3:2024 Biocompatibility evaluation of EN ISO 18562-3:2024
breathing gas pathways in
healthcare applications —
Part 3: Tests for emissions of
volatile organic substances
ISO 18562-4:2024 ISO 18562-4:2024 Biocompatibility evaluation of EN ISO 18562-4:2024
breathing gas pathways in
healthcare applications —
Part 4: Tests for leachables in
condensate
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-clause 2017/745 that
where this defines or u
...
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