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 medizinischen Geräts 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 behandelt 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 behandelt nicht die biologische Beurteilung der Oberflächen von Medizinprodukten in direktem Kontakt mit dem Patienten oder Benutzer. 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 [25] [27] [30]-[32], 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.
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/FDIS 18562-1:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18562-1:2023
01-januar-2023
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO/DIS
18562-1:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO/DIS
18562-1:2022)
Évaluation de la biocompatibilité des chemins 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/DIS 18562-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 18562-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18562-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 18562-1:2023
oSIST prEN ISO 18562-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-1
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-04 2023-01-27
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
ICS: 11.040.10
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-1
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
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
ISO/CEN PARALLEL PROCESSING
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(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 .11
4.1 General . 11
4.2 Type tests . 13
4.3 Biocompatibility hazard identification . 13
4.4 Extent of risk assessment . . 14
4.5 Biocompatibility evaluation plan . 14
4.6 Selection of tests . 16
4.7 Subsequent evaluation . 17
5 Contamination of breathing gas from gas pathways .17
5.1 Duration of contact . 17
5.2 Particulate matter (PM) emissions . 18
5.3 Volatile organic substance emissions . 18
5.4 Leachables in condensate . 18
6 Adjustment for different patient groups .18
6.1 General considerations. 18
6.2 Adjustment for body weight . 19
7 Deriving allowable limits .20
7.1 General process . 20
7.2 For medical devices intended for limited exposure use (≤24 h) . 21
7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d) . 21
7.4 For medical devices intended for long-term exposure (≥30 d) .22
8 Risk control .22
9 Benefit-risk analysis .23
10 Biocompatibility evaluation report .23
Annex A (informative) Rationale and guidance .24
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .27
Annex C (informative) Reference to the essential principles .29
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .30
Bibliography .33
Terminology — Alphabetized index of defined terms .35
iii
oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(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 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: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment, 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 of ISO 18562-1 cancels and replaces the first edition of ISO 18562-1.
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 appropriate breathing gas volumes to used in the analysis.
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 18562-1:2023
ISO/DIS 18562-1:2022(E)
Introduction
This document represents the application of the best-known science, in order to improve patient safety,
by addressing the risk of potentially hazardous substances being conveyed to the patient by the gas
stream.
This document is
...
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