Assistive products for tissue integrity when lying down - Part 7: Foam properties, characteristics and performance (ISO/TR 20342-7:2021)

This document lists the terminology and common test methods used by manufacturers and laboratories to quantify the performance of a foam material. It also and gives information to users or buyers of these products to make an educated assessment of the relevance of the physical characteristics between various products offered to them.
This document summarizes/gives information about the tests for
—    polyurethane foams – typically polyether (polyether polyurethane foam) or polyester based (polyester polyurethane foam) – produced by either slabstock (slabstock foam) or moulded foam process, and
—    latex foams produced by either the Dunlop process or Talalay process.
The physical properties addressed in this document are
a) resilience,
b) hysteresis,
c) support/SAG factor,
d) density,
e) hardness,
f) compression set,
g) tensile strength,
h) tear strength,
i) air flow/permeability,
j) resistance to fatigue, and
k) microbial resistance.
NOTE       The test methods presented in this document do not necessarily simulate conditions of use in practice. The use of resulting data is therefore restricted to a broad comparative assessment between different foam products.
This document addresses only the characterization and performance of foam materials used in APTIs. It does not address the design, construction method or other factors relating to the final clinical efficiency of the product.
Test methods for characterizing the physical properties of any coverings, or the effects of any coverings on the physical properties of the foams, are not addressed in this document.

Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 7: (ISO/TR 20342-7:2021)

Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 7: Propriétés, caractéristiques et performances des mousses (ISO/TR 20342-7:2021)

Le présent document répertorie la terminologie et les méthodes d’essai courantes utilisées par les fabricants et les laboratoires pour quantifier les performances d’un matériau en mousse. Il fournit également des informations aux utilisateurs ou aux acheteurs de ces produits afin qu’ils puissent évaluer en toute connaissance de cause la pertinence des caractéristiques physiques des différents produits qui leur sont proposés.
Le présent document résume/donne des informations sur les essais:
—    des mousses de polyuréthane, généralement à base de polyéther (mousse de polyuréthane de polyéther) ou de polyester (mousse de polyuréthane de polyester), produites selon un procédé de coulée souple (mousse en bloc) ou de moulage;
—    des mousses de latex produites selon le procédé Dunlop ou le procédé Talalay.
Les propriétés physiques abordées dans le présent document sont:
a) la résilience,
b) l’hystérésis,
c) le facteur de soutien/SAG,
d) la masse volumique,
e) la dureté,
f) la déformation rémanente après compression,
g) la résistance à la traction,
h) la résistance au déchirement,
i) l’écoulement d’air/la perméabilité,
j) la résistance à la fatigue, et
k) la résistance microbienne.
NOTE            Les méthodes d’essai présentées dans le présent document ne simulent pas nécessairement les conditions d’utilisation dans la pratique. L’utilisation des données obtenues est donc limitée à une évaluation comparative globale entre différents produits en mousse.
Le présent document ne traite que de la caractérisation et des performances des matériaux mousses utilisés dans les PAIT. Il ne traite pas de la conception, de la méthode de fabrication ou d’autres facteurs associés à l’efficacité clinique finale du produit.
Les méthodes d’essai permettant de caractériser les propriétés physiques de tout revêtement ou les effets de tout revêtement sur les propriétés physiques des mousses ne sont pas couverts par le présent document.

Tehnični pripomočki za celovitost tkiv v ležečem položaju - 7. del: Lastnosti, značilnosti in delovanje pene (ISO/TR 20342-7:2021)

Ta dokument vsebuje informacije o preskusnih metodah, potrebnih za določanje fizikalnih lastnosti najpogosteje uporabljenih pen za proizvodnjo tehničnih pripomočkov za celovitost tkiv.
Ta dokument obravnava samo lastnosti in delovanje penastih materialov, ki se uporabljajo v tehničnih pripomočkih za celovitost tkiv. Ne obravnava zasnove, metode konstrukcije ali drugih dejavnikov, ki se navezujejo na končno klinično učinkovitost izdelka.

General Information

Status
Published
Publication Date
26-Apr-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
27-Apr-2022
Completion Date
27-Apr-2022

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SLOVENSKI STANDARD
01-junij-2022
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 7. del: Lastnosti,
značilnosti in delovanje pene (ISO/TR 20342-7:2021)
Assistive products for tissue integrity when lying down - Part 7: Foam properties,
characteristics and performance (ISO/TR 20342-7:2021)
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 7: (ISO/TR 20342-
7:2021)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 7:
Propriétés, caractéristiques et performances des mousses (ISO/TR 20342-7:2021)
Ta slovenski standard je istoveten z: CEN ISO/TR 20342-7:2022
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.

CEN ISO/TR 20342-7
TECHNICAL REPORT
RAPPORT TECHNIQUE
April 2022
TECHNISCHER BERICHT
ICS 11.180.01
English Version
Assistive products for tissue integrity when lying down -
Part 7: Foam properties, characteristics and performance
(ISO/TR 20342-7:2021)
Produits d'assistance pour l'intégrité des tissus en Unterstützende Produkte zur Gewebeintegrität im
position allongée - Partie 7: Propriétés, Liegen - Teil 7: (ISO/TR 20342-7:2021)
caractéristiques et performances des mousses (ISO/TR
20342-7:2021)
This Technical Report was approved by CEN on 13 April 2022. It has been drawn up by the Technical Committee CEN/TC 293.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 20342-7:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TR 20342-7:2021 has been prepared by Technical Committee ISO/TC 173 "Assistive
products” of the International Organization for Standardization (ISO) and has been taken over as
the secretariat of which is held by SIS.
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.
A complete listing of these bodies can be found on the CEN website.
Endorsement notice
The text of ISO/TR 20342-7:2021 has been approved by CEN as CEN ISO/TR 20342-7:2022 without any
modification.
TECHNICAL ISO/TR
REPORT 20342-7
First edition
2021-08
Assistive products for tissue integrity
when lying down —
Part 7:
Foam properties, characteristics and
performance
Reference number
ISO/TR 20342-7:2021(E)
©
ISO 2021
ISO/TR 20342-7:2021(E)
© ISO 2021
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 2021 – All rights reserved

ISO/TR 20342-7:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Test samples and foam properties . 4
4.1 General . 4
4.2 Test samples . 4
4.3 Presale literature . 5
4.4 Composite APTIs . 5
4.5 Foam density and hardness . 5
4.6 Aging effects . 5
5 Test methods . 6
5.1 General . 6
5.2 Determination of foam type . 6
5.2.1 Resilience (ball rebound) . 6
5.2.2 Hysteresis . 6
5.2.3 Support/SAG factor . 6
5.3 Characterization of foam durability . 6
5.3.1 Density (core or apparent). 6
5.3.2 Tensile strength and elongation . 7
5.3.3 Tear strength . 7
5.3.4 Compression set (wet and/or dry) . 7
5.4 Characterization of foam hardness . 7
5.4.1 General. 7
5.4.2 Indentation hardness . 8
5.4.3 Compression hardness . 8
5.5 Characterization of other properties . 8
5.5.1 Dynamic Fatigue Test (Pounding) . 8
5.5.2 Dynamic Fatigue Test (Roller) . 8
5.5.3 Air flow/permeability . 8
5.5.4 Flammability . 8
5.5.5 Microbial resistance . 9
5.5.6 Restricted substances . 9
Annex A (informative) Cross-reference guide between related ISO, ASTM, CEN and JIS standards .10
Bibliography .11
ISO/TR 20342-7:2021(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 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 2021 – All rights reserved

ISO/TR 20342-7:2021(E)
Introduction
Although the phrase ‘high specification foam mattress’ has been common in the industry for several
decades, its continued use today is now a cause for concern.
The first ‘high specification foam mattresses’ wer
...

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