SIST EN ISO 18562-3:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017)

Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 3. del: Preskusi emisij hlapnih organskih spojin (VOC) (ISO 18562-3:2017)

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 18562-3:2020
01-april-2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 3. del:
Preskusi emisij hlapnih organskih spojin (VOC) (ISO 18562-3:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3:
Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 3: Prüfungen für Emissionen von flüchtigen organischen Verbindungen (VOCs) (ISO
18562-3:2017)
Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications de
soins de santé - Partie 3: Essais concernant les émissions de composés organiques
volatils (COV) (ISO 18562-3:2017)
Ta slovenski standard je istoveten z: EN ISO 18562-3:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18562-3:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18562-3:2020
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 18562-3:2020
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 18562-3
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 3: Tests for emissions of
volatile organic compounds (VOCs) (ISO 18562-3:2017)
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 3: Prüfungen
Partie 3: Essais concernant les émissions de composés für Emissionen von flüchtigen organischen
organiques volatils (COV) (ISO 18562-3:2017) Verbindungen (VOCs) (ISO 18562-3:2017)
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 18562-3:2020 E
worldwide for CEN national Members.

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SIST EN ISO 18562-3:2020
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 18562-3:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 18562-3:2020
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 18562-3:2020 (E)
European foreword
The text of ISO 18562-3:2017 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 18562-3:2020 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 18562-3:2017 has been approved by CEN as EN ISO 18562-3:2020 without any
modification.

3

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SIST EN ISO 18562-3:2020
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 18562-3:2020
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 18562-3
First edition
2017-03
Biocompatibility evaluation of
breathing gas pathways in healthcare
applications —
Part 3:
Tests for emissions of volatile organic
compounds (VOCs)
Évaluation de la biocompatibilité des voies de gaz respiratoires dans
les applications de soins de santé —
Partie 3: Essais concernant les émissions de composés organiques
volatils (COV)
Reference number
ISO 18562-3:2017(E)
©
ISO 2017

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SIST EN ISO 18562-3:2020
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 18562-3:2017(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 18562-3:2020
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 18562-3:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles . 2
4.1 Type tests . 2
4.2 General . 2
5 * Voc emissions . 3
5.1 General . 3
5.2 Acceptance criteria . 3
5.3 Test method . 4
Annex A (informative) Rationale and guidance . 9
Annex B (informative) Reference to the essential principles .10
Annex C (informative) Terminology — Alphabetized index of defined terms .11
Bibliography .12
© ISO 2017 – All rights reserved iii

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SIST EN ISO 18562-3:2020
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 18562-3:2017(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 of the ISO 18562 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

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SIST EN ISO 18562-3:2020
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 18562-3:2017(E)

Introduction
This document is intended to protect patients connected to medical devices from excessive amounts
of volatile organic compounds (vocs) that arise from within the gas pathways of those medical
devices. This document represents the application of the best-known science by addressing the risks
from potentially hazardous vocs being conveyed to the patient by the gas stream.
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.
[1]
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 detect vocs.
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 only address the potential contamination
generated from within the medical device itself. This contamination might be from the original
manufacturing process or generated by the medical device itself during use.
This document is concerned with volatile organic compounds that could be conveyed to the patient
by the breathing gases. Volatile organic compounds can have health effects ranging from unpleasant
odour and irritation of the mucous membranes to possible long-term effects on the nervous system. It is
accepted that there is no point in setting levels that are lower than those found in air that people might
breathe every day.
The tests for the presence of volatile organic compounds generated by respiratory medical devices
are based on advanced laboratory practice and require specialist training and equipment to generate
meaningful results.
The methods to determine the acceptable levels of contamination are contained in ISO 18562-1.
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:
a) “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
b) “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
c) “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 18562-3:2020
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 18562-3:2017(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 18562-3:2020
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 18562-3:2017(E)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 3:
Tests for emissions of volatile organic compounds (VOCs)
1 Scope
This document specifies tests for the emissions of volatile organic compounds (vocs) 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 emissions of vocs that are added to the respirable gas stream by the
materials of the gas pathway. This document establishes acceptance criteria for these tests.
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
[1]
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 series.
This document is intended to be read in conjunction with ISO 18562-1.
NOTE This document has been prepared to address the relevant essential principles of safety and
performance as indicated in Annex B.
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 2017 – All rights reserved 1

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SIST EN ISO 18562-3:2020
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 18562-3:2017(E)

ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 16000-6:2011, Indoor air — Part 6: Determination of volatile organic compounds in indoor and test
chamber air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using
MS or MS-FID
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ASTM D5466-01, Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres
(Canister Sampling Methodology)
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
are given in Annex C.
3.1
rated
term referring to a value assigned by the manufacturer for a specified operating condition
[SOURCE: IEC 60601-1:2005, 3.97]
3.2
thermal stability
condition under which the temperature of an object does not change by more than 2 °C over a period of 1 h
[SOURCE: IEC 60601-1:2005, 3.125, modified — “increase” has been changed to “change”.]
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 made regarding 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 18562-3:2017(E)

The fundamental consideration in assessing a substance is “what is the dose to the patient of this
substance?”
Limits for toxicological purposes are most often quoted in µg/d (tolerable exposure). Limits for
environmental purposes, and the quantity that is measured by test laboratories, are usually quoted as
3 3
concentrations in µg/m . To calculate the permitted concentration of that substance (in µg/m ) in the
breathing gas, the total volume of gas inhaled in a day is required. The dose to the patient depends on
3 3
the concentration of the substance (in µg/m ) multiplied by the volume (in m ) inhaled by the patient.
Standard daily breathing volumes are found in ISO 18562-1:2017, 6.3.
5 * Voc emissions
5.1 General
All gas pathways from which the patient inspires gas shall be evaluated for voc emissions. The
evaluation should use the risk management process to assess if testing is required.
NOTE 1 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.
A medical device, part or accessory shall not add to the gas that could be inspired by the patient
vocs at levels that create an unacceptable risk to the patient.
NOTE 2 Parts downstream of the patient can be evaluated for voc emissions if there is a risk that the patient
might inspire gas that has been in contact with them.
If the risk management process determines that testing is required, the tests of 5.3 shall be performed.
5.2 Acceptance criteria
The dose-to-patient of any substance for which a TI is calculated shall be below that TI.
The dose-to-patient of any substance for which a TI is not calculated shall be below the TTC for all
values relevant to the exposure category as indicated in Table 1.
When the “first 24-h test” returns a very low value, below that allowed for longer term use, then further
tests need not be performed.
EXAMPLE 1 Where the limited exposure dose-to-patient of a substance is below 120 µg/d for a prolonged
exposure medical device, further testing is not required as shown in Figure 1, green bar E.
EXAMPLE 2 Where the limited exposure or prolonged exposure dose-to-patient of a substance is below
40 µg/d for a permanent contact medical device, further testing is not required as shown in Figure 1, green bar D.
Table 1 — TTC limits by exposure
Length of
Exposure Ttc
patient
category ug/d
exposure
Limited
≤24 h 360 — —
exposure
Prolonged >24 h and 360, 120, for the sub-
—
exposure <30 d for first 24 h sequent 29 d
Permanent 360, 120, for the sub- 40,
≥30 d
a
contact for first 24 h sequent 29 d beyond 30 d
a
Figure 1, green bar E or blue curve G.
© ISO 2017 – All rights reserved 3

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ISO 18562-3:2017(E)

5.3 Test method
Perform voc emission testing as follows.
a) Set up the medical device, part or accessory according to the instructions for use.
It can be necessary to use additional accessories in order to perform this test (for example, hoses
or a test lung). When using such additional items, care needs to be taken to prepare them so that
they do not interfere with the measurements being made. Alternatively, the test may be run with
all the accessories in place, but without the medical device under test to produce a blank value.
This blank value is then subtracted from the value obtained when running t
...