SIST EN ISO 20342-4:2026

SLOVENSKI STANDARD
01-april-2026
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 4. del: Preskusne
metode za trajnost (ISO 20342-4:2026)
Assistive products for tissue integrity when lying down - Part 4: Test methods for
durability (ISO 20342-4:2026)
Hilfsmittel zur Gewebeintegrität im Liegen - Teil 4: Testmethoden für Haltbarkeit (ISO
20342-4:2026)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 4: Méthodes
d'essai de durabilité (ISO 20342-4:2026)
Ta slovenski standard je istoveten z: EN ISO 20342-4:2026
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20342-4
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2026
EUROPÄISCHE NORM
ICS 11.180.01
English Version
Assistive products for tissue integrity when lying down -
Part 4: Test methods for durability (ISO 20342-4:2026)
Produits d'assistance pour l'intégrité des tissus en Hilfsmittel zur Gewebeintegrität im Liegen - Teil 4:
position allongée - Partie 4: Méthodes d'essai de Testmethoden für Haltbarkeit (ISO 20342-4:2026)
durabilité (ISO 20342-4:2026)
This European Standard was approved by CEN on 6 February 2026.

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, Türkiye 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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20342-4:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20342-4:2026) has been prepared by Technical Committee ISO/TC 173
"Assistive products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and
accessibility” the secretariat of which is held by SIS.
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 2026, and conflicting national standards shall
be withdrawn at the latest by August 2026.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20342-4:2026 has been approved by CEN as EN ISO 20342-4:2026 without any
modification.
International
Standard
ISO 20342-4
First edition
Assistive products for tissue
2026-02
integrity when lying down —
Part 4:
Test methods for durability
Produits d'assistance pour l'intégrité des tissus en position
allongée —
Partie 4: Méthodes d'essai de durabilité
Reference number
ISO 20342-4:2026(en) © ISO 2026

ISO 20342-4:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20342-4:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Common test equipment . 2
5 Test method for determining the durability of an APTI placed on an articulated support
platform . 3
5.1 Principle .3
5.2 Test equipment − Test support platform .3
5.3 Test specifications .4
5.3.1 Number of cycles required .4
5.3.2 Evaluation criteria .5
5.4 Procedure .5
5.5 Test report .6
6 Test method for determining the durability of an APTI to withstand user movement . 6
6.1 Principle .6
6.2 Test equipment – Loading pad .6
6.3 Test specifications .7
6.3.1 Number of cycles required .7
6.3.2 Evaluation criteria .8
6.4 Procedure .8
6.5 Test report .9
7 Test method for determining the durability of an APTI to withstand storage and
operating environmental conditions . 9
7.1 Principle .9
7.2 Test equipment − Environmental chamber .9
7.3 Test specifications .9
7.3.1 Testing conditions .9
7.3.2 Evaluation criteria .9
7.4 Procedure .9
7.5 Test report .10
8 Test method for determining the durability of an APTI to withstand user repositioning
on an APTI toward the head end of a bed . 10
8.1 Principle .10
8.2 Test equipment .10
8.3 Test specifications .11
8.3.1 Testing conditions .11
8.3.2 Evaluation criteria .11
8.4 Procedure . 12
8.5 Test report . 12
9 Test report .12
Bibliography . 14

iii
ISO 20342-4:2026(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of 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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive products
and accessibility, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
A list of all parts in the ISO 20342 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 20342-4:2026(en)
Introduction
Assistive products for tissue integrity (APTIs) play an integral role in any care plan for the prevention and
treatment of pressure injuries. They can make a difference in quality of life for any user with limited mobility.
Since no one APTI is best for all users, a wide variety of APTIs, including mattresses, mattress overlays
and integrated bed systems, are available in a broad array of materials. Choosing from this growing list of
alternatives has become a daunting task for clinicians, care givers and users. Selecting from the available
alternatives is further complicated by the lack of consistent information regarding APTI characteristics.
Clinicians, manufacturers, distributors and users all stand to benefit from the development of standardized
procedures to evaluate the characteristics of APTI. Detailed information provided by standardized testing
will help clinicians objectively match the characteristics of an APTI to the needs of individual users. Testing
standards will also aid manufacturers by guiding new product development and in the redesign of existing
products. Testing standards will promote quality assurance within the manufacturing process. Distributors
too, will benefit by being able to clearly describe and compare products from multiple manufacturers. Lastly,
users will benefit by having APTIs that truly support their needs.
This document includes the test methods for the evaluation of the durability of APTIs in the lying position in
different application environments, such as hospitals, home care and institutions. Some of the devices can
be used or reused in more than one application environment. This means that different test methods can
be applied to the same APTI depending on the application environment. This document offers several test
methods, not all of which are appropriate for all APTIs, and, therefore, the manufacturer should determine
which are appropriate for their APTIs’ construction and use.
APTIs play a very important role in the prevention and treatment of pressure injuries. Healthcare workers
implement prevention and treatment strategies, which include risk assessment, skin monitoring and
repositioning. Guidance on the role of APTIs can be found in Reference [6].

v
International Standard ISO 20342-4:2026(en)
Assistive products for tissue integrity when lying down —
Part 4:
Test methods for durability
1 Scope
This document specifies conditions and test methods for the durability of assistive products for tissue
integrity (APTI) when lying down. These methods are additional to the ones in ISO 20342-1.
This document is applicable to both reactive and active APTIs, such as mattresses and overlays, and includes
single-patient multiple-use products.
This document does not apply to single-use products.
NOTE This document is intended to help differentiate the durability characteristics between APTIs. It is not
intended for determining overall performance or for ranking or scoring of such APTIs.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
durability
ability of a product to perform its required function over an expected period under normal conditions of use
and maintenance
Note 1 to entry: Several units of measure can be used to express the expected lifetime of a product according to its
field of application, such as years of life, hours of use or operational cycles.
3.2
expected lifetime
manufacturer’s design life of the assistive product for tissue integrity (APTI) which is the period of time
during which the APTI performs as intended by the manufacturer under normal conditions
Note 1 to entry: Different components of an APTI can have different expected lifetimes.

ISO 20342-4:2026(en)
3.3
single-patient multiple-use
intended by the manufacturer to be reused on an individual user for multiple
uses
1)
[SOURCE: ISO 20417:— , 3.38, modified — The preferred term “single patient multiple use” was changed to
“single-patient multiple-use”; “patient” was changed to “user”; Notes 1 and 2 to entry were removed.]
3.4
single-use
intended by the manufacturer to be used on an individual user or specimen
during a single procedure and then disposed of
[SOURCE: ISO 20417:—, 3.39, modified — The preferred terms “do not reuse” and “use only once” were
removed; “patient” was changed to “user ”; Notes 1 and 2 to entry was removed.]
4 Common test equipment
The test methods use the following common pieces of testing equipment.
4.1 Body analogue simulated mass, a mass of material (e.g. lead shot bags) held together in a fashion
to simulate the size and shape of a user. Two loading conditions shall be used in this document: one loading
condition is the maximum user mass of the APTI under test and the other loading condition is the value
where the mass would cover 90 % of the intended user population as defined by the manufacturer. The
mass distribution of the simulated body mass should load each of the zones of the APTI in percentages, as
indicated in Figure 1. The body analogue simulated mass should be secured to ensure they maintain the
body shaped position during cycling.
The manufacturer may elect to run all test cycles at maximum user mass.
1) Under preparation. Stage at the time of publication: ISO/FDIS 20417.

ISO 20342-4:2026(en)
Key
1 back section – 45 % of test conditions mass
2 seat section – 25 % of test conditions mass
3 upper leg section – 20 % of test conditions mass
4 lower leg section – 10 % of test conditions mass
Figure 1 — Mass distribution zones by percentage
4.2 Sheet, either fitted or flat depending on the instructions for use of the APTI.
5 Test method for determining the durability of an APTI placed on an articulated
support platform
5.1 Principle
This method is used to evaluate the durability of an APTI intended to be used on an articulated (adjustable)
mattress support platform. The test method simulates compressive and tensile loads at the bending points
of the APTI that it would experience during intended use.
This test method is only applicable for products which are intended to be used when the support platform is
articulated.
5.2 Test equipment − Test support platform
A bed frame or support platform upon which the APTI is intended to be utilized should be used and
justification for the selection provided.
Alterna
...