SIST EN ISO 18562-2:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)

Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 2. del: Preskusi emisij delcev (ISO 18562-2:2017)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SLOVENSKI STANDARD
SIST EN ISO 18562-2:2020
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
SIST EN ISO 18562-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.

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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.

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 18562-2:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN ISO 18562-2:2020 (E)
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.

3

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 18562-2:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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 2017 – All rights reserved iii

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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 levels of contamination are based on worldwide published health data for particulates.
It is accepted that there is no point in setting a level that is lower than that found in air that people
might breathe every day of their lives.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type;
— test specifications: italic type;
— terms defined in Clause 3 of this document or as noted: small capitals type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
© ISO 2017 – All rights reserved v

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 18562-2:2017(E)

The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised
ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the
content of this publication be adopted for implementation nationally not earlier than 3 years from
the date of publication for equipment newly designed and not earlier than 5 years from the date of
publication for equipment already in production.
vi © ISO 2017 – All rights reserved

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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INTERNATIONAL STANDARD ISO 18562-2:2017(E)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 2:
Tests for emissions of particulate matter
1 Scope
This document 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.
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA)
in setting limits based solely on particle size and not their chemistry.
This document addresses potential contamination of the gas stream arising from the gas pathways,
which is then conducted to the patient.
This document 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.
This document 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.
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).
NOTE 2 This document has been prepared to address the relevant essential principles of safety and
performance as indicated in Annex B.
© ISO 2017 – All rights reserved 1

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SIST EN ISO 18562-2:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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ISO 18562-2:2017(E)

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7396-1, ISO 14971, ISO 18562-1
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
NOTE For convenience, an alphabetized index of all defined terms and their sources used in this document is
given in Annex C.
3.1
diameter
aerodynamic diameter
3
diameter of a sphere of density 1 g/cm with the same terminal velocity due to gravitational force in
calm air as the particle of interest, regardless of its geometric size, shape and true density, under the
prevailing conditions of temperature, pressure and relative humidity
[SOURCE: ISO 7708:1995, 2.2, modified — added “of interest, regardless of its geometric size, shape and
true density”]
4 General principles
4.1 Type tests
The tests described in this document are type tests. Type tests are performed on the final medical
device, a component of the medical device or a representative sample of the medical device, part
or accessory being evaluated. If representative samples are used (i.e. manufactured and processed
by equivalent methods), consideration should be given to whether or not the differences between
the representative sample and the final medical device or component could affect the results of the
test. Testing of representative samples (manufactured and processed by equivalent methods) instead
of the final medical device should be supported by a description of any differences between the
representative sample and the final medical device, and a detailed rationale for why each difference is
not expected to impact the biocompatibility of the final medical device.
NOTE Some authorities having jurisdiction evaluate these differences and rationales.
4.2 General
All gas pathways from which the patient inspires gas shall be evaluated using the strategy detailed in
ISO 18562-1.
2 © ISO 2017 – All rights reserved

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ISO 18562-2:2017(E)

5 * Particulate matter emissions
5.1 General
A medical device, part or accessory shall not add to the gas that could be inspired by the patient
levels of particulate matter:
3
— less than or equal to 2,5 µm diameter, in excess of 12 µg/m ;
3
— less than or equal to 10 µm diameter, in excess of 150 µg/m .
[5]
NOTE 1 The allowable limits are taken from the US EPA 40 § CFR Part 50 .
All gas pathways from which the patient inspires gas shall be evaluated for particulate matter
emissions. The evaluation should use the risk management process to assess if testing is required.
NOTE 2 The evaluation of some components, which are identical in formulation, processing and preparation
for use to an existing component of a medical device that has been previously tested, might conclude that no
further testing is required. Refer to ISO 18562-1:2017, Figure 2.
Evaluation and, if required, testing shall take in to account:
— the expected service life;
— the effects of any intended processing or reprocessing;
— the worst-case patient exposure.
The manufacturer shall document this evaluation as well as the criteria for selection of test articles
and methodologies, including component parts to be tested, duration of testing in relation to the
intended duration of clinical use.
NOTE 3 Some authorities having jurisdiction evaluate these rationales.
If the risk management process determines that testing is required, the testing according to 5.5, 5.6,
or 5.7 shall be performed. For testing according to 5.5, use the setup according to either 5.3 or 5.4. The
manufacturer may choose the appropriate test method.
Compliance is checked by risk management plan and risk management file.
5.2 Testing methods overview
There is a great variety of components and medical devices within the scope of this document, and
so several different methods are proposed. The manufacturer should select the most appropriate
method for their particular application. A simple component such as a connector with minimal area
exposed to the patient breathing gas stream is very unlikely to need testing for particulate matter,
while a mechanical medical device with moving parts such as a ventilator could well require thorough
testing.
The simplest method (described in 5.3) is to use a single particle filter to trap everything with a
3
diameter over 0,2 µm, and consider the limit to be 12 µg/m for all trapped particles. This is a quick
simple test that does not differentiate particle sizes. It may be sufficient for simple medical devices. It
is very difficult to measure very small amounts of particulate matter captured using a barrier filter
test method since the mass of the filter is substantially more than that of the particulate matter. The
volume of gas used in the test should therefore be large enough to capture a sufficiently large amount
of particulate matter to be able to measure it or prove that the total mass of particulate matter is
below the allowed amount.
If the manufacturer wishes to test for the different particle sizes, with th
...