ISO/FDIS 18562-1
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 18562-1:2017 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. ISO 18562-1:2017 covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g. by generating particulates). 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. ISO 18562-1:2017 addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient. ISO 18562-1:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing. ISO 18562-1:2017 does not address biological evaluation of the surfaces of medical devices that are in 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 equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, 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. ISO 18562-1:2017 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). Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic agents added to the gas stream. NOTE 1 Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation. NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.
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 18562-1:2017 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. ISO 18562-1:2017 couvre les principes généraux relatifs à l'évaluation de la biocompatibilité des matériaux constituant un dispositif médical, qui composent le chemin de gaz, mais ne couvre pas les phénomènes dangereux biologiques causés par une défaillance mécanique, à moins que celle-ci n'introduise un risque de toxicité (par exemple en générant des particules). 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. ISO 18562-1:2017 traite de la contamination potentielle du flux gazeux provenant des chemins de gaz utilisés dans un dispositif médical, qui pourrait ensuite être acheminé jusqu'au patient. ISO 18562-1:2017 s'applique pour la durée de vie prévue du dispositif médical en utilisation normale et prend en compte les effets associés à tout traitement ou retraitement prévu. ISO 18562-1:2017 ne traite pas de l'évaluation biologique des surfaces des dispositifs médicaux 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 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 compris le matelas et la surface intérieure d'une cloche de Hood, sont considérés comme des chemins de gaz et sont également couverts par le présent document. ISO 18562-1:2017 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 anti-retour 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, ne sont pas couverts par l'ISO 18562 (toutes les parties). Des parties pourraient être ajoutées ultérieurement pour traiter d'autres aspects pertinents des essais biologiques, notamment la contamination supplémentaire qui pourrait résulter des chemins de gaz en raison de la présence de médicaments et d'agents anesthésiques dans les flux gazeux. NOTE 1 Certaines autorités compétentes demandent que ces risques soient évalués dans le cadre d'une évaluation biologiq
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ISO/FDIS 18562-1
ISO/TC 121/SC 3
Biocompatibility evaluation
Secretariat: ANSI
of breathing gas pathways in
Voting begins on:
healthcare applications —
2023-12-20
Part 1:
Voting terminates on:
2024-02-14
Evaluation and testing within a risk
management process
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
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Reference number
ISO/FDIS 18562-1:2023(en) © ISO 2023
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ISO/FDIS 18562-1:2023(en)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18562-1
ISO/TC 121/SC 3
Biocompatibility evaluation of
Secretariat: ANSI
breathing gas pathways in healthcare
Voting begins on:
applications —
Voting terminates on:
Part 1:
Evaluation and testing within a risk
management process
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
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© ISO 2023
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be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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IN ADDITION TO THEIR EVALUATION AS
Website: www.iso.org Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 18562-1:2023(E)
Published in Switzerland
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
© ISO 2023 – All rights reserved
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
ii
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ISO/FDIS 18562-1:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles applying to biocompatibility evaluation of medical devices .11
4.1 General . 11
4.2 Type tests . 14
4.3 Biocompatibility hazard identification . 14
4.4 Extent of risk assessment . .15
4.5 Biologic
...
ISO/FDIS 18562--1:2024(E)
ISO /TC 121/SC 3
ISO TC 121/SC 3/WG 13
2023-11-27
Secretariat: ANSI
Date: 2023-12-08
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
Évaluation de la biocompatibilité des voieschemins de gaz respiratoiresrespiratoire utilisés dans les
applicationsle domaine de soins dela santé —
Partie 1: Évaluation et essais au sein d’und'un processus de gestion du risque
FDIS stage
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ISO/FDIS 18562-1:2024(E)
© ISO 2024 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO'sISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 • CP 401 • Ch. de Blandonnet 8
CH-12111214 Vernier, Geneva 20
Tel.Phone: + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail: copyright@iso.org
Web www.iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2024 – All rights reserved
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ISO/FDIS 18562-1:2023(E)
Contents
Foreword . Error! Bookmark not defined.
Introduction. Error! Bookmark not defined.
1 Scope . Error! Bookmark not defined.
2 Normative references . Error! Bookmark not defined.
3 Terms and definitions . Error! Bookmark not defined.
4 General principles applying to biocompatibility evaluation of medical devices . Error!
Bookmark not defined.
4.1 General . Error! Bookmark not defined.
4.2 Type tests . Error! Bookmark not defined.
4.3 Biocompatibility hazard identification . Error! Bookmark not defined.
4.4 Extent of risk assessment . Error! Bookmark not defined.
4.5 Biological evaluation plan . Error! Bookmark not defined.
4.6 Selection of tests . Error! Bookmark not defined.
4.7 Subsequent evaluation . Error! Bookmark not defined.
5 Contamination of breathing gas from gas pathways . Error! Bookmark not defined.
5.1 Duration of contact . Error! Bookmark not defined.
5.2 Particulate matter ( PM ) emissions . Error! Bookmark not defined.
5.3 Volatile organic substance emissions . Error! Bookmark not defined.
5.4 Leachables in condensate . Error! Bookmark not defined.
6 Adjustment of exposure dose and inhalation dose for different patient groups . Error!
Bookmark not defined.
6.1 General considerations . Error! Bookmark not defined.
6.2 Adjustment for different patient groups . Error! Bookmark not defined.
7 Deriving tolerable exposure ( TE ) for VOS . Error! Bookmark not defined.
7.1 General process . Error! Bookmark not defined.
7.2 For medical devices intended for limited exposure use (≤24 h) and prolonged exposure use
(>24 h but <30 d) . Error! Bookmark not defined.
7.3 For medical devices intended for long-term exposure (≥30 d)Error! Bookmark not defined.
8 Determining values for leachables in condensate . Error! Bookmark not defined.
8.1 General .
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