SIST EN ISO 18562-1:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)

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.

Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO 18562-1:2017)

Dieses Dokument legt Folgendes fest:
- die allgemeinen Grundsätze für die biologische Beurteilung in einem RISIKOMANAGEMENTPROZESS von GASWEGEN eines MEDIZINPRODUKTES sowie von dessen Teilen oder ZUBEHÖR, die für die Beatmung oder die Zufuhr von Stoffen über die Atemwege eines PATIENTEN in allen Umgebungen vorgesehen sind;
- die allgemeine Klassifizierung von GASWEGEN auf der Grundlage der Art und Dauer ihres Kontakts mit dem Gasstrom;
- die Beurteilung vorhandener 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 Bewertung der biologischen Sicherheit des GASWEGS.
Dieses Dokument behandelt die allgemeinen Grundsätze der Beurteilung der BIOKOMPATIBILITÄT von Werkstoffen von MEDIZINPRODUKTEN, aus denen der GASWEG besteht, jedoch nicht die aus einem mechanischen Versagen entstehenden biologischen GEFÄHRDUNGEN, sofern das Versagen kein ToxizitätsRISIKO verursacht (z. B. durch Erzeugen von PARTIKELN). Die anderen Teile von ISO 18562 behandeln spezifische Prüfungen, die potenziell gefährliche Stoffe betreffen, die dem Atemgasstrom hinzugefügt werden, und erstellen Akzeptanzkriterien für diese Stoffe.
Dieses Dokument behandelt die potenzielle Verunreinigung des Gasstroms aus den GASWEGEN innerhalb des MEDIZINPRODUKTS, die anschließend dem PATIENTEN zugeführt werden könnte.
Dieses Dokument gilt für die ZU ERWARTENDE BETRIEBS-LEBENSDAUER des MEDIZINPRODUKTS bei BESTIMMUNGSGEMÄßEM GEBRAUCH und berücksichtigt die Auswirkungen jeder beabsichtigten Aufbereitung oder Wiederaufbereitung.
Dieses Dokument behandelt nicht die biologische Beurteilung der Oberflächen von MEDIZINPRODUKTEN 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, Mundstücke, Wiederbelebungsgeräte, Atemschläuche, Atemsystemfilter, 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 in den Leitungsauslässen), Ausgänge von Druckminderen, 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.
Zukünftige Teile könnten ergänzt werden, um andere relevante Aspekte der biologischen Prüfung zu behandeln, einschließlich zusätzlicher Verunreinigungen, die aus dem GASWEG durch die Anwesenheit von Medikamenten und Anästhesiemitteln, die dem Gasstrom hinzugefügt werden, entstehen könnten.
ANMERKUNG 1 Einige ZUSTÄNDIGE BEHÖRDEN fordern die Bewertung dieser RISIKEN als Teil einer biologischen Beurteilung.
ANMERKUNG 2 Dieses Dokument wurde erstellt, um die relevanten grundlegenden Prinzipien der Sicherheit und Leistungsmerkmale zu behandeln, wie in Anhang B angegeben.

Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications de soins de santé - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO 18562-1:2017)

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 env

Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del: Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-1:2017)

General Information

• Status: Published
• Public Enquiry End Date: 09-Oct-2019
• Publication Date: 12-Mar-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Nov-2024
• Due Date: 30-Nov-2024
• Ref Project: EN ISO 18562-1:2020 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)

Relations

• Replaced By: SIST EN 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)
• Effective Date: 01-Dec-2024

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-
1:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO 18562-1:2017)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO
18562-1:2017)
Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications de
soins de santé - Partie 1: Évaluation et essais au sein d'un processus de gestion du
risque (ISO 18562-1:2017)
Ta slovenski standard je istoveten z: EN ISO 18562-1:2020
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
February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing
within a risk management process (ISO 18562-1:2017)
Évaluation de la biocompatibilité des voies de gaz Beurteilung der Biokompatibilität der Atemgaswege
respiratoires dans les applications de soins de 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 18562-1:2017) Prozesses (ISO 18562-1:2017)
This European Standard was approved by CEN on 11 November 2019.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18562-1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 18562-1:2017 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 18562-1:2020 by 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 August 2020, and conflicting national standards shall
be withdrawn at the latest by August 2020.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 18562-1:2017 has been approved by CEN as EN ISO 18562-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 18562-1
First edition
2017-03
Biocompatibility evaluation of
breathing gas pathways in healthcare
applications —
Part 1:
Evaluation and testing within a risk
management process
Évaluation de la biocompatibilité des voies de gaz respiratoires dans
les applications de soins de santé —
Partie 1: Évaluation et essais au sein d’un processus de gestion du
risque
Reference number
ISO 18562-1:2017(E)
©
ISO 2017
ISO 18562-1:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ii © ISO 2017 – All rights reserved

ISO 18562-1:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles applying to biocompatibility evaluation of medical devices .6
4.1 General . 6
4.2 Type tests . 7
4.3 Biocompatibility hazard identification . 8
4.4 Extent of risk assessment . 8
4.5 Biocompatibility evaluation plan . 9
4.6 Selection of tests .10
4.7 Subsequent evaluation .10
5 Contamination of breathing gas from gas pathways .11
5.1 * Duration of use .11
5.2 Particulate matter (pm) emissions .13
5.3 Volatile organic compound (voc) emissions .13
5.4 Leachable substances in condensate .13
6 Adjustment for different patient groups .13
6.1 General considerations .13
6.2 Adjustment for body weight .13
6.3 * Deriving a permitted concentration from a tolerable exposure .14
7 * Deriving allowable limits .14
7.1 General process .14
7.2 For medical devices intended for limited exposure use (≤24 h) .15
7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d) .16
7.4 For medical devices intended for permanent contact (≥30 d) .16
8 Risk benefit analysis .16
9 Assess the biocompatibility of the medical device .17
Annex A (informative) Rationale and guidance .18
Annex B (informative) Reference to the essential principles .20
Annex C (informative) Terminology — Alphabetized index of defined terms .21
Bibliography .23
ISO 18562-1:2017(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 on the voluntary nature of ISO 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 the following
URL: w w w . i s o .org/ iso/ foreword .html.
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
A list of all parts in the ISO 18562 series can be found on the ISO websi
...