SIST EN ISO 18562-2:2020
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)
ISO 18562-2:2017 specifies tests for the emissions of particulate matter from 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 tests of this document are intended to quantify particles from 0,2 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 µm in diameter.
NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction.
ISO 18562-2:2017 therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
ISO 18562-2:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.
ISO 18562-2:2017 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 18562-2:2017 does not address biological evaluation of the surfaces of gas pathways 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 devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such 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 18562-2:2017 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).
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 2: Prüfungen für Emissionen von Partikeln (ISO 18562-2:2017)
Dieses Dokument legt Prüfungen für die Emissionen von PARTIKELN aus den GASWEGEN eines MEDIZINPRODUKTS sowie von dessen Teilen oder ZUBEHÖR fest, die für die Beatmung oder die Zufuhr von Stoffen über die Atemwege zum PATIENTEN in allen Umgebungen vorgesehen sind. Die Prüfungen in diesem Dokument dienen dazu, Partikel mit einem DURCHMESSER von 0,2 µm bis 10 µm, die von einem MEDIZINPRODUKT, dessen Teilen oder ZUBEHÖR in den atembaren Gasstrom abgegeben werden, zu quantifizieren. Dieses Dokument erstellt Akzeptanzkriterien für diese Prüfungen. Dieses Dokument behandelt keine Nanopartikel. Für die Festlegung der Expositionsgrenzwerte für Partikel mit einem DURCHMESSER von weniger als 0,2 µm stehen keine ausreichenden Daten zur Verfügung.
ANMERKUNG 1 Kleinere und größere Partikel könnten ebenfalls biologische GEFÄHRDUNGEN darstellen und zusätzliche Informationen außerhalb des Anwendungsbereichs dieses Dokuments können erforderlich sein, um die Anforderungen einiger ZUSTÄNDIGER BEHÖRDEN zu erfüllen.
Dieses Dokument wendet daher denselben Ansatz wie die US Environmental Protection Agency (EPA) an, die Grenzwerte, ausschließlich auf Basis der Partikelgröße und nicht ihrer chemischen Zusammensetzung festlegt.
Dieses Dokument behandelt die potenzielle Verunreinigung des Gasstroms aus den GASWEGEN, die anschließend dem PATIENTEN zugeführt wird.
Dieses Dokument gilt über 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 GASWEGEN 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), Atem¬systeme, Sauerstoff Dosiersysteme, Sauerstoff Konzentratoren, Vernebler, Niederdruck-Schlauchsysteme, Anfeuchter, Wärme und Feuchtigkeitsaustauscher, Atemgas Überwachungsgeräte, Atmungsüberwachungs¬geräte, Masken, Mundstücke, Wiederbelebungsgeräte, Atemschläuche, Atemsystemfilter, Y Stücke und jedes für den Einsatz mit solchen Geräten 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 ROHRLEITUNGS¬SYSTEMEN FÜR MEDIZINISCHE GASE (einschließlich Rückschlagventilen an den Leitungsauslässen), Ausgängen von Druckminderern, die mit Flaschen für medizinische Gase verbunden oder in diese integriert sind, oder in das MEDIZINPRODUKT eintretende Raumluft, werden nicht durch ISO 18562 (alle Teile) behandelt.
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 2: Essais concernant les émissions de matières particulaires (ISO 18562-2:2017)
ISO 18562-2:2017 spécifie les essais concernant les émissions des matières particulaires provenant 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. Les essais contenus dans le présent document sont destinés quantifier les particules dont le diamètre est compris entre 0,2 µm et 10 µm et qui sont émises par le dispositif médical, ses parties ou ses accessoires dans le flux de gaz respirable. Le présent document établit les critères d'acceptation de ces essais. Le présent document ne traite pas des nanoparticules. Il n'existe pas de données suffisantes pour établir des limites d'exposition relatives aux particules d'un diamètre inférieur à 0,2 µm.
NOTE 1 Des particules plus petites et plus grandes pourraient également présenter des phénomènes dangereux biologiques, et des informations supplémentaires en dehors du domaine d'application de la présente norme peuvent s'avérer nécessaires afin de répondre aux exigences de certaines autorités compétentes.
ISO 18562-2:2017 adopte donc la même approche que l'US Environmental Protection Agency (EPA) (Agence américaine de protection de l'environnement) en établissant des limites fondées uniquement sur la taille des particules et non pas sur leurs propriétés chimiques.
ISO 18562-2:2017 traite de la contamination potentielle du flux gazeux provenant des chemins de gaz, qui est ensuite acheminé jusqu'au patient.
ISO 18562-2:2017 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 18562-2:2017 ne traite pas de l'évaluation biologique des surfaces des chemins de gaz 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 des systèmes respiratoires, 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 18562-2:2017 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'IS
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del: Preskusi emisij delcev (ISO 18562-2:2017)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del:
Preskusi emisij delcev (ISO 18562-2:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2:
Tests for emissions of particulate matter (ISO 18562-2:2017)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 2: Prüfungen für Emissionen von Partikeln (ISO 18562-2:2017)
Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications de
soins de santé - Partie 2: Essais concernant les émissions de matières particulaires (ISO
18562-2:2017)
Ta slovenski standard je istoveten z: EN ISO 18562-2:2020
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 18562-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 2: Tests for emissions of
particulate matter (ISO 18562-2:2017)
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 2: Prüfungen
Partie 2: Essais concernant les émissions de matières für Emissionen von Partikeln (ISO 18562-2:2017)
particulaires (ISO 18562-2:2017)
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 18562-2:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 18562-2:2017 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 18562-2:2020 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 18562-2:2017 has been approved by CEN as EN ISO 18562-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 18562-2
First edition
2017-03
Biocompatibility evaluation of
breathing gas pathways in healthcare
applications —
Part 2:
Tests for emissions of particulate
matter
Évaluation de la biocompatibilité des voies de gaz respiratoires dans
les applications de soins de santé —
Partie 2: Essais concernant les émissions de matières particulaires
Reference number
ISO 18562-2:2017(E)
©
ISO 2017
ISO 18562-2:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
ISO 18562-2:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles . 2
4.1 Type tests . 2
4.2 General . 2
5 * Particulate matter emissions . 3
5.1 General . 3
5.2 Testing methods overview . 3
5.3 Single filter test setup . 4
5.4 Double filter test setup . 5
5.5 Test method . 6
5.6 Measuring particulate matter emissions according to particle size . 7
5.7 * Measuring particulate matter emissions by particle counter . 7
5.8 Medical devices with time varying emissions . 7
Annex A (informative) Rationale and guidance . 8
Annex B (informative) Reference to the essential principles .13
Annex C (informative) Terminology — Alphabetized index of defined terms .14
Bibliography .15
ISO 18562-2:2017(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 website.
iv © ISO 2017 – All rights reserved
ISO 18562-2:2017(E)
Introduction
This document is intended to protect patients connected to medical devices from excessive amounts
of particulate matter that arises from within gas pathways of medical devices.
This document is intended to cover the biological evaluation of gas pathways of medical devices within
a risk management process, as part of the overall medical device evaluation and development. This
approach combines the review and evaluation of existing data from all sources with, where necessary,
the selection and application of additional tests.
[2]
In general, the ISO 10993 series is intended to cover the biological evaluation of medical
devices. However, the ISO 10993 series does not appropriately address the biological evaluation of
the gas pathways of medical devices. For example, the ISO 10993 tests do not evaluate inspired
particulate matter.
It is not within the scope of this document to address contamination arising from the source of the
breathing gases entering such medical devices, but rather address only the potential contamination
generated from within the medical device itself. This contamination might be from the original
manufacturing process or be generated by the medical device itself during use.
This document is concerned with particulate matter that could be conveyed to the patient by the
breathing gases. The smaller the particle, the deeper into the lungs it can penetrate and the longer it
takes the body to eliminate it. Originally, the main health concerns with regard to particulate matter
were focused on respiratory health, but now there is emerging evidence of effects on the cardiovascular
system as well.
The tests for the presence of particulate matter generated by respiratory medical devices are based
on standard laboratory practice and require no advanced techniques or equipment.
The acceptable l
...
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