FprEN ISO 20342-4

SLOVENSKI STANDARD
oSIST prEN ISO 20342-4:2025
01-junij-2025
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 4. del: Preskusne
metode za trajnost (ISO/DIS 20342-4:2025)
Assistive products for tissue integrity when lying down - Part 4: Test methods for
durability (ISO/DIS 20342-4:2025)
Titre manque - Partie 4: Titre manque
Ta slovenski standard je istoveten z: prEN ISO 20342-4
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
oSIST prEN ISO 20342-4:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 20342-4:2025
oSIST prEN ISO 20342-4:2025
DRAFT
International
Standard
ISO/DIS 20342-4
ISO/TC 173
Assistive products for tissue
Secretariat: SIS
integrity when lying down —
Voting begins on:
Part 4: 2025-05-02
Test methods for durability
Voting terminates on:
2025-07-25
ICS: 11.180.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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NATIONAL REGULATIONS.
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 20342-4:2025(en)
oSIST prEN ISO 20342-4:2025
DRAFT
ISO/DIS 20342-4:2025(en)
International
Standard
ISO/DIS 20342-4
ISO/TC 173
Assistive products for tissue
Secretariat: SIS
integrity when lying down —
Voting begins on:
Part 4:
Test methods for durability
Voting terminates on:
ICS: 11.180.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 20342-4:2025(en)
ii
oSIST prEN ISO 20342-4:2025
ISO/DIS 20342-4:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Common test equipment . 2
4.1 Body analogue simulated weight .2
4.2 Sheet .2
5 Test method for determining the durability of an APTI placed on an articulated support
platform . 3
5.1 Scope and rationale .3
5.2 Test equipment .3
5.2.1 Test support platform .3
5.3 Test specifications .3
5.3.1 Number of cycles required .3
5.3.2 Evaluation criteria .4
5.4 Test method .4
5.5 Test report .4
6 Test method for determining the durability of an APTI to withstand user movement . 5
6.1 Scope and rationale .5
6.2 Test equipment .5
6.2.1 Loading pad .5
6.3 Test specifications .5
6.3.1 Number of cycles required .5
6.3.2 Evaluation criteria .6
6.4 Test method .6
6.5 Test report .7
7 Test method for determining the durability of an APTI to withstand storage and
operating environmental conditions . 7
7.1 Scope and rationale .7
7.2 Test equipment .7
7.2.1 Environmental chamber .7
7.3 Test specifications .7
7.3.1 Testing conditions .7
7.3.2 Evaluation criteria .7
7.4 Test method .8
7.5 Test report .8
8 Test method for determining the durability of an APTI to withstand user repositioning
on an APTI toward the head end of a bed . 8
8.1 Scope and rationale .8
8.2 Test equipment .8
8.2.1 Repositioning sheet.8
8.2.2 Pulling fixture . .8
8.3 Test specifications .9
8.3.1 Testing conditions .9
8.3.2 Evaluation criteria .9
8.4 Test method .9
8.5 Test report .9
9 Test report .10
Annex A (informative) Information about the validation tests conducted .11

iii
oSIST prEN ISO 20342-4:2025
ISO/DIS 20342-4:2025(en)
Bibliography .12

iv
oSIST prEN ISO 20342-4:2025
ISO/DIS 20342-4:2025(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.
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.

v
oSIST prEN ISO 20342-4:2025
ISO/DIS 20342-4:2025(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 monumental 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 part of ISO 20342 includes the test methods for the evaluation of the durability of assistive products for
tissue integrity (APTI) 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 will be appropriate for all APTIs,
and therefore, the manufacturer is to 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
implementing prevention and treatment strategies, which include risk assessment, skin monitoring and
repositioning. Guidance can be found in the NPIAP/EPUAP/PPPIA Guidelines, "Prevention and Treatment of
[1]
Pressure Ulcers: Clinical Practice Guideline,” from 2019 .’

vi
oSIST prEN ISO 20342-4:2025
DRAFT International Standard ISO/DIS 20342-4:2025(en)
Assistive products for tissue integrity when lying down —
Part 4:
Test methods for durability
1 Scope
This part of ISO 20342 specifies conditions and test methods for the durability of assistive products for
tissue integrity (APTI) when lying down additional to ISO 20342-1.
This document is applicable to APTIs, such as mattresses and overlays, and includes single patient multiple
use products.
This document does not apply to single use products.
NOTE It 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.
Note 2 to entry: Different components of an APTI can have different life expectations.
3.2
single patient multiple use
intended by the manufacturer to be reused on an individual user for multiple uses
[SOURCE: ISO 20417:2021,3.25, modified - Notes 1 and 2 were removed.]
3.3
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 20417:2021,3.26, modified - Note 1 was removed.]

oSIST prEN ISO 20342-4:2025
ISO/DIS 20342-4:2025(en)
3.4
expected lifetime
manufacturer’s design life of the APTI or the period of time during which the APTI is safe to use and performs
as intended by the manufacturer
4 Common test equipment
The following test methods will reference these common pieces of testing equipment.
4.1 Body analogue simulated weight
This is a mass of material (e.g. lead shot bags) held together in a fashion to simulate the size and shape of a
user. This document will require 2 loading cases: one loading case is the maximum user weight of the APTI
under test and the other loading case i
...