oSIST prEN ISO 18562-1:2023
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (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)
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 indica
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)
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 d
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del: Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO/DIS 18562-1:2022)
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.
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oSIST prEN ISO 18562-1:2023
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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.
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
Contents Page
Foreword .
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