SIST EN ISO 18562-1:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)

Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del: Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-1:2017)

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.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
SLOVENSKI STANDARD
SIST EN ISO 18562-1:2020
01-april-2020
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO 18562-
1:2017)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO 18562-1:2017)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO
18562-1:2017)
Évaluation de la biocompatibilité des voies 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 18562-1:2017)
Ta slovenski standard je istoveten z: EN ISO 18562-1:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18562-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 18562-1:2020
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

---------------------- Page: 2 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing
within a risk management process (ISO 18562-1:2017)
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 1: Beurteilung
Partie 1: Évaluation et essais au sein d'un processus de und Prüfung innerhalb eines Risikomanagement-
gestion du risque (ISO 18562-1:2017) Prozesses (ISO 18562-1:2017)
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 18562-1:2020 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2020 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2020 (E)
European foreword
The text of ISO 18562-1:2017 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 18562-1:2020 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 18562-1:2017 has been approved by CEN as EN ISO 18562-1:2020 without any
modification.

3

---------------------- Page: 5 ----------------------
SIST EN ISO 18562-1:2020
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

---------------------- Page: 6 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1
First edition
2017-03
Biocompatibility evaluation of
breathing gas pathways in healthcare
applications —
Part 1:
Evaluation and testing within a risk
management process
Évaluation de la biocompatibilité des voies de gaz respiratoires dans
les applications de soins de santé —
Partie 1: Évaluation et essais au sein d’un processus de gestion du
risque
Reference number
ISO 18562-1:2017(E)
©
ISO 2017

---------------------- Page: 7 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(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

---------------------- Page: 8 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles applying to biocompatibility evaluation of medical devices .6
4.1 General . 6
4.2 Type tests . 7
4.3 Biocompatibility hazard identification . 8
4.4 Extent of risk assessment . 8
4.5 Biocompatibility evaluation plan . 9
4.6 Selection of tests .10
4.7 Subsequent evaluation .10
5 Contamination of breathing gas from gas pathways .11
5.1 * Duration of use .11
5.2 Particulate matter (pm) emissions .13
5.3 Volatile organic compound (voc) emissions .13
5.4 Leachable substances in condensate .13
6 Adjustment for different patient groups .13
6.1 General considerations .13
6.2 Adjustment for body weight .13
6.3 * Deriving a permitted concentration from a tolerable exposure .14
7 * Deriving allowable limits .14
7.1 General process .14
7.2 For medical devices intended for limited exposure use (≤24 h) .15
7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d) .16
7.4 For medical devices intended for permanent contact (≥30 d) .16
8 Risk benefit analysis .16
9 Assess the biocompatibility of the medical device .17
Annex A (informative) Rationale and guidance .18
Annex B (informative) Reference to the essential principles .20
Annex C (informative) Terminology — Alphabetized index of defined terms .21
Bibliography .23
© ISO 2017 – All rights reserved iii

---------------------- Page: 9 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(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

---------------------- Page: 10 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(E)

Introduction
This document represents the application of the best-known science, in order to improve patient
safety, by addressing the risk of potentially hazardous substances 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.
In general, the ISO 10993 series is intended to cover the biological evaluation of medical devices.
However, the ISO 10993 series does not sufficiently address the biological evaluation of the gas
pathways of medical devices.
Before this document was developed, some authorities having jurisdiction interpreted the
ISO 10993-1:2009, Table A.1 to mean that materials in the gas pathway form “indirect contact” with
the patient, and should be subjected to tests equivalent to those required for tissue contact parts of
medical devices. This interpretation can lead to tests with questionable benefit and also to possible
hazards not being detected.
ISO 10993-1:2009 states that it is not intended to provide a rigid set of test methods as this might result
in an unnecessary constraint on the development and use of novel medical devices. ISO 10993-1:2009
also states where a particular application warrants it, experts in the product or in the area of application
concerned can choose to establish specific tests and criteria, described in a product-specific vertical
standard. This new series of standards is intended to address the specific needs for the evaluation of
gas pathways that are not adequately covered by ISO 10993-1:2009.
This document provides a guide to the development of a biological evaluation plan that minimizes
the number and exposure of test animals by giving preference to chemical constituent testing and
in vitro models.
The initial version of this series of standards was intended to cover only the most commonly found
potentially harmful substances. It was felt that it was best to get a functioning document published
that would test for the bulk of the currently known substances of interest. With the use of the ttc
(threshold of toxicological concern) approach, this document has the potential to be used
to assess the safety of essentially any compound released from the gas pathways of respiratory
medical devices, with very few exceptions (e.g. PCBs, dioxins), and not just the most commonly found
potentially harmful substances. Later amendments and additional parts are planned to explicitly cover
less common substances.
In this document, the following print types are used:
— requirements and definitions: roman type;
— test specifications: italic 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;
— terms defined in Clause 3 of this document or as noted: small capitals.
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;
© ISO 2017 – All rights reserved v

---------------------- Page: 11 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(E)

— “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.
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
or IEC 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

---------------------- Page: 12 ----------------------
SIST EN ISO 18562-1:2020
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 STANDARD ISO 18562-1:2017(E)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
1 Scope
This document 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.
This document 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.
This document addresses potential contamination of the gas stream arising from the gas pathways
within the medical device, which might then be 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 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 2017 – All rights reserved 1

---------------------- Page: 13 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(E)

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).
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 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 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-17:2002, Biological evaluation of medical devices — Part 17: Establishment of allowable limits
for leachable substances
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 18562-2, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2:
Tests for emissions of particulate matter
ISO 18562-3, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3:
Tests for emissions of volatile organic compounds (VOCs)
ISO 18562-4, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4:
Tests for leachables in condensate
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7396-1, ISO 14971 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
accessory
additional part for use with a medical device in order to:
2 © ISO 2017 – All rights reserved

---------------------- Page: 14 ----------------------
SIST EN ISO 18562-1:2020
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 18562-1:2017(E)

— achieve the intended use,
— adapt it to some special use,
— facilitate its use,
— enhance its performance, or
— enable its function to be integrated with those of other medical devices
[SOURCE: IEC 60601-1:2005, 3.3, modified — substituted “medical device” for “equipment”]
3.2
biocompatibility
ability to be in contact with a living system without producing an unacceptable adverse effect
Note 1 to entry: Medical devices may produce some level of adverse effect, but that level may be determined to
be acceptable when considering the benefits provided by the medical device.
3.3
expected service life
maximum period of useful life as defined by the manufacturer
[SOURCE: IEC 60601-1:2005+AMD1: 2012, 3.28]
3.4
formulation
base
...