SIST EN ISO 18562-4:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)

Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 4. del: Preskusi izlužnin v kondenzatih (ISO 18562-4:2017)

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 18562-4:2020
01-april-2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 4. del:
Preskusi izlužnin v kondenzatih (ISO 18562-4:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4:
Tests for leachables in condensate (ISO 18562-4:2017)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO 18562-4:2017)
Évaluation de la biocompatibilité des voies de gaz respiratoires dans les applications de
soins de santé - Partie 4: Essais concernant les substances relargables dans le
condensat (ISO 18562-4:2017)
Ta slovenski standard je istoveten z: EN ISO 18562-4:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18562-4:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.

Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

EN ISO 18562-4
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 4: Tests for leachables in
condensate (ISO 18562-4:2017)
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 4: Prüfungen
Partie 4: Essais concernant les substances relargables für herauslösbare Substanzen in Kondensaten (ISO
dans le condensat (ISO 18562-4:2017) 18562-4:2017)
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 18562-4:2020 E
worldwide for CEN national Members.

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SIST EN ISO 18562-4:2020
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 18562-4:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 18562-4:2020
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 18562-4:2020 (E)
European foreword
The text of ISO 18562-4:2017 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 18562-4:2020 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 18562-4:2017 has been approved by CEN as EN ISO 18562-4:2020 without any
modification.

3

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SIST EN ISO 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
INTERNATIONAL ISO
STANDARD 18562-4
First edition
2017-03
Biocompatibility evaluation of
breathing gas pathways in healthcare
applications —
Part 4:
Tests for leachables in condensate
Évaluation de la biocompatibilité des voies de gaz respiratoires dans
les applications de soins de santé —
Partie 4: Essais concernant les substances relargables dans le
condensat
Reference number
ISO 18562-4:2017(E)
©
ISO 2017

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SIST EN ISO 18562-4:2020
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 18562-4:2017(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 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 18562-4:2017(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 Leachable substances in condensate . 3
5.1 General . 3
5.2 * Test method . 3
Annex A (informative) Rationale and guidance . 5
Annex B (informative) Reference to the essential principles . 7
Annex C (informative) Terminology — Alphabetized index of defined terms .8
Bibliography . 9
© ISO 2017 – All rights reserved iii

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SIST EN ISO 18562-4:2020
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 18562-4:2017(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 18562-4:2020
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 18562-4:2017(E)

Introduction
This document is intended to protect patients connected to medical devices from excessive amounts
of harmful substances that might be contained in water that has condensed in the gas pathways of
those medical devices. This document represents the application of the best-known science by
addressing the risks from potentially hazardous substances in the condensate being conveyed to the
patient by the gas pathway. The condensate itself will be distilled water, having condensed from
the vapour phase, but liquid water present in the breathing system might be able to leach or absorb
other substances from within the medical device. This contamination might be from the original
manufacturing process or be generated by the medical device itself during use.
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.
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.
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 substances that could be conveyed to the patient by liquid
condensate forming in the medical device and then subsequently reaching the lungs of the patient.
Potentially harmful substances that could be found in condensate include salts and metals. Condensate
management is part of most healthcare institution protocols, with the primary aim of preventing the
condensate reaching the patient in the first place. The absolute volume of liquid reaching a patient
by this route should therefore be low, but it might happen. This document outlines tests for substances
contained in the liquid.
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.
© ISO 2017 – All rights reserved v

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SIST EN ISO 18562-4:2020
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 18562-4:2017(E)

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.
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 18562-4:2020
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 18562-4:2017(E)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 4:
Tests for leachables in condensate
1 Scope
This document specifies tests for substances leached by liquid water condensing into 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 hazardous water-soluble substances that are leached from the medical device,
its parts or accessories by condensate and then conveyed by that liquid to the patient. 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 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 c
...