SIST-TP CEN ISO/TR 20342-7:2022
(Main)Assistive products for tissue integrity when lying down - Part 7: Foam properties, characteristics and performance (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)
This document gives information on the test methods necessary for the characterization of the physical properties of the most commonly used foams for the manufacture of APTIs.
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
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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 20342-7:2022
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
SIST-TP CEN ISO/TR 20342-7:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
---------------------- Page: 2 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
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.
---------------------- Page: 3 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
CEN ISO/TR 20342-7:2022 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
CEN ISO/TR 20342-7:2022 (E)
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
CEN ISO/TR 20342-7:2022 by Technical Committee CEN/TC 293 “Assistive products and accessibility”
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.
3
---------------------- Page: 5 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
---------------------- Page: 6 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
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
---------------------- Page: 7 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
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 2021 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
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
---------------------- Page: 10 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
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’ were introduced around the 1990s. These incorporated
multiple construct layers of different foams, some of which might be castellated and/or shaped, and
then enveloped in stretch covers to provide improved pressure reducing properties when compared
with the then, ‘standard hospital mattress’, which was essentially a single rectangular block of foam
protected by a non-stretch cover. Over time these more advanced, complicated multi-layer constructs
have themselves now become the norm, completely replacing the old product in most modern hospitals.
Continued use of the ‘high specification’ terminology creates the risk of confusion and allows
manufacturers to lay claim to providing a ‘high specification foam mattress’ without an agreed
benchmark against which to justify this claim. The continued use of this phrase also takes the focus
away from the principles of holistic care and the correct risk assessment leading hopefully to the
selection of the mattress that will most likely deliver the desired outcome depending on the needs of
the patient.
Looking at the different clinical requirements and physical properties for foam mattresses, different
properties and their values come into play depending on the identified needs. A single property that
might be considered ‘high’ specification or highly desirable in relation to one patient or healthcare
environment could well be deemed ‘low’ or somewhat unimportant when considered against the needs
of the next patient in a different environment. Ultimately, it is the performance of the mattress as a
whole, within its environment, rather than any individual component part of it, that is important.
Understanding the characteristics of foam can help inform and potentially aid in the choice when
several products are available. However, it is the performance of the complete product, based on the
individual’s assessed needs, which is critical to ensure optimal patient care.
Without knowing the current (and often evolving) clinical needs of every particular user, it is not
possible to define clearly a nominal or minimal/maximal performance specification that needs to be
met or surpassed by the final product.
Additional safety standards, such as fire resistance at a component and/or final product level, exist
in relation to the foam product addressed in this document. The minimum level of resistance legally
required potentially differs depending on the application environment, for example domestic versus
hospital use. The flammability requirements and test methods used currently differ depending on the
country or state of use.
The manufacturer is required to explain and corroborate any claims made concerning the important
features of their product and how these features assure the clinical efficiency of their product over its
expected lifetime.
Based on this information and/or local, national or international requirements, it remains, however,
the responsibility of the user to determine if the foam proposed provides merely adequate behaviour or
exceeds by a significant amount the performance required.
Not all of the proposed tests need to be carried out to give an indication of a foam's performance and
some of the proposed tests will not be considered relevant for some types of foam.
These test methods can be used to identify differing performance characteristics between products
thus indicating the potential superior performance of one foam over another.
It is emphasized that the test methods specified 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.
© ISO 2021 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
It is recommended that no single result be taken in isolation. The clinical efficiency of the final product
will also be the result of many different contributory factors, a large number of which will not be related
to the foam’s physical properties.
The type of cover (fabric or other) used on the APTI can have a significant effect on overall clinical
performance of the final product. An incorrectly fitted cover, or changing the cover to a product other
than that specified by the manufacturer, will possibly affect product safety, performance and durability.
Continued use of a damaged cover can result in penetration of liquids into the foam, not only potentially
affecting its performance, but also increasing the risk of cross contamination.
The type of bedframe, or support, onto which the APTI is placed potentially affects the performance of
the final product. Overall product dimensions need to be taken into account not only to ensure that the
APTI can function correctly, but also to ensure that no entrapment hazards are created between the
frame and the APTI.
vi © ISO 2021 – All rights reserved
---------------------- Page: 12 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
TECHNICAL REPORT ISO/TR 20342-7:2021(E)
Assistive products for tissue integrity when lying down —
Part 7:
Foam properties, characteristics and performance
1 Scope
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.
© ISO 2021 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
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 20342-1, Assistive products for tissue integrity when lying down — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20342-1 and the following
apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
assistive product for tissue integrity
APTI
surface intended to protect body tissue, designed to interface with the body when lying down or in
adjusted position
[SOURCE: ISO 20342-1:2019, 3.5]
3.2
bottoming out
insufficient support provided by an assistive product for tissue integrity (3.1) for the mass of patient
concerned, at the place where the assistive product for tissue integrity is no longer capable of
redistributing the pressure applied
Note 1 to entry: Localized pressure risks are now placed onto the patient by the bed frame or support surface
onto which the assistive product for tissue integrity has been placed.
3.3
destructive test
test method resulting in damage or destruction of the sample being tested
Note 1 to entry: The preparation of this test part renders an assistive product for tissue integrity (3.1) unsuitable
for use afterwards.
3.4
Dunlop process
action where foamed liquid latex is poured into a mould before vulcanization (3.10)
Note 1 to entry: Continuous production [see slabstock foam (3.11.6)] using the Dunlop process is also possible.
3.5
elongation
length of elongation at the rupture point as a percentage of the original length
3.6
tensile strength
force necessary to rupture the foam (3.11) when pulled by opposite forces
3.7
hydrolysis
chemical reaction in which the interaction of a compound with water results in the gradual
decomposition of that compound
2 © ISO 2021 – All rights reserved
---------------------- Page: 14 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
3.8
non-destructive test
test method that can be carried out without damaging the sample being tested
Note 1 to entry: An assistive product for tissue integrity (3.1) is not significantly altered by the test and is deemed
suitable for use afterwards.
3.9
Talalay process
action where foamed liquid latex is poured into a mould then placed under vacuum before vulcanization
(3.10)
3.10
vulcanization
chemical cross linking of rubber-based polymers to increase product rigidity and durability
3.11
foam
flexible cellular material in which the cells are all or partly intercommunicating
3.11.1
high resilience foam
HR foam
foam (3.11) characterized by higher elasticity, measured by ball rebound or comfort factor (SAG factor),
as compared with standard polyether polyurethane foams
Note 1 to entry: Special high resilience polyols are used frequently in combination with methylene diphenyl di-
isocyanate (MDI) rather than toluene di-isocyanate.
Note 2 to entry: The higher elasticity is attributed to a more irregular cell structure than that present in standard
ether based foams.
3.11.2
latex foam
flexible cellular material made from natural or synthetic latex (3.11.2.2), in which the cells are all or
partly intercommunicating
3.11.2.1
natural latex
latex produced from the sap of the Hevea Brasiliensis rubber tree
3.11.2.2
synthetic latex
petroleum based alternative to natural latex (3.11.2.1)
3.11.3
moulded foam
cellular foam (3.11) product, having the form of the mould cavity in which it was produced
3.11.4
polyester polyurethane foam
foam (3.11) manufactured using polyester polyols in combination with toluene di-isocyanate (TDI)
Note 1 to entry: Polyester foams have a higher natural stability against solvents than polyether foams, but a
lower stability towards hydrolysis (3.7).
© ISO 2021 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
3.11.5
polyether polyurethane foam
foam (3.11) manufactured using high levels of polyether polyols in combination with toluene di-
isocyanate (TDI)
Note 1 to entry: Sometimes also referred to as a conventional foam, conventional polyurethane foam, or standard
polyurethane foam.
3.11.6
slabstock foam
cellular foam (3.11) product, produced from an often continuous manufacturing process, where the slab
of foam produced is then cut to shape to produce the final part
3.11.7
viscoelastic foam
modified polyurethane foam (3.11) obtained by the use of special polyols or a modified cellular
structure
Note 1 to entry: Viscoelastic foam is characterized by a low final hardness, a delayed recovery after compression,
and low elasticity.
Note 2 to entry: Often also known as a memory foam. Its capacity of enveloping/adapting to the shape of the
patient can help reduce and redistribute pressure.
4 Test samples and foam properties
4.1 General
The supplier of a foam will indicate whether their foam product is polyurethane or latex based.
The characterization of the physical properties of a foam product is determined by subjecting the foam
to a number of standardized laboratory tests that are referenced in Clause 5. The results of these tests
allow the comparative performance of different products, under laboratory conditions, to be evaluated.
4.2 Test samples
[5]
For the test methods listed in this document, ISO 1923 can be followed for assessing sample
[1]
dimensions, and ISO 291 for conditioning the test samples.
Some tests are carried out on normalized (i.e. predetermined and constant shape and size) sample
parts. The reported value for these tests is therefore not influenced by the original shape or size of the
product.
Examples such as core density, compression hardness, and compression set require destructive (parts
cut to the correct shape and size) tests. Results from these tests will then generally allow direct
comparison between differing foam products. Other test methods, such as indentation hardness, are
carried out directly on the final product using non-destructive methods. However, the results obtained
from different products will not be directly comparable unless the parts tested have identical shapes/
dimensions.
NOTE It is important, when comparing resulting values between different foams, to ensure that the same
test method has been used. Whilst many test methods are common across the industry some minor differences
still exist - for example the percentage of compression used when measuring foam hardness or the units used to
express the result.
For both types of test typical values given are on the basis of the following:
a) The foam has been correctly manufactured to ensure normal properties and performance.
4 © ISO 2021 – All rights reserved
---------------------- Page: 16 ----------------------
SIST-TP CEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
b) The foam has been recently manufactured and not subject to any ageing (real or artificial) or other
post-manufacturing treatment, other than any demanded by the test method, that could alter its
claimed properties and performance.
The following variations are relevant:
a) Foam material test piece
If an APTI has been created with multiple stacks, profiles and holes, the test result of a foam alone does
not necessarily indicate the full characteristics of the complete APTI.
b) Laminated test piece of a structure used in an APTI
The cited International Standards are test evaluations of a single material, but it is desirable to evaluate
an APTI in a complete form to compare the characteristics of different APTIs.
Some APTIs have different structures in
...
SLOVENSKI STANDARD
kSIST-TP FprCEN ISO/TR 20342-7:2022
01-februar-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: Titre
manque (ISO/TR 20342-7:2021)
Ta slovenski standard je istoveten z: FprCEN ISO/TR 20342-7
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
kSIST-TP FprCEN ISO/TR 20342-7:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
---------------------- Page: 2 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
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
---------------------- Page: 3 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
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 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
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
---------------------- Page: 6 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
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’ were introduced around the 1990s. These incorporated
multiple construct layers of different foams, some of which might be castellated and/or shaped, and
then enveloped in stretch covers to provide improved pressure reducing properties when compared
with the then, ‘standard hospital mattress’, which was essentially a single rectangular block of foam
protected by a non-stretch cover. Over time these more advanced, complicated multi-layer constructs
have themselves now become the norm, completely replacing the old product in most modern hospitals.
Continued use of the ‘high specification’ terminology creates the risk of confusion and allows
manufacturers to lay claim to providing a ‘high specification foam mattress’ without an agreed
benchmark against which to justify this claim. The continued use of this phrase also takes the focus
away from the principles of holistic care and the correct risk assessment leading hopefully to the
selection of the mattress that will most likely deliver the desired outcome depending on the needs of
the patient.
Looking at the different clinical requirements and physical properties for foam mattresses, different
properties and their values come into play depending on the identified needs. A single property that
might be considered ‘high’ specification or highly desirable in relation to one patient or healthcare
environment could well be deemed ‘low’ or somewhat unimportant when considered against the needs
of the next patient in a different environment. Ultimately, it is the performance of the mattress as a
whole, within its environment, rather than any individual component part of it, that is important.
Understanding the characteristics of foam can help inform and potentially aid in the choice when
several products are available. However, it is the performance of the complete product, based on the
individual’s assessed needs, which is critical to ensure optimal patient care.
Without knowing the current (and often evolving) clinical needs of every particular user, it is not
possible to define clearly a nominal or minimal/maximal performance specification that needs to be
met or surpassed by the final product.
Additional safety standards, such as fire resistance at a component and/or final product level, exist
in relation to the foam product addressed in this document. The minimum level of resistance legally
required potentially differs depending on the application environment, for example domestic versus
hospital use. The flammability requirements and test methods used currently differ depending on the
country or state of use.
The manufacturer is required to explain and corroborate any claims made concerning the important
features of their product and how these features assure the clinical efficiency of their product over its
expected lifetime.
Based on this information and/or local, national or international requirements, it remains, however,
the responsibility of the user to determine if the foam proposed provides merely adequate behaviour or
exceeds by a significant amount the performance required.
Not all of the proposed tests need to be carried out to give an indication of a foam's performance and
some of the proposed tests will not be considered relevant for some types of foam.
These test methods can be used to identify differing performance characteristics between products
thus indicating the potential superior performance of one foam over another.
It is emphasized that the test methods specified 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.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
It is recommended that no single result be taken in isolation. The clinical efficiency of the final product
will also be the result of many different contributory factors, a large number of which will not be related
to the foam’s physical properties.
The type of cover (fabric or other) used on the APTI can have a significant effect on overall clinical
performance of the final product. An incorrectly fitted cover, or changing the cover to a product other
than that specified by the manufacturer, will possibly affect product safety, performance and durability.
Continued use of a damaged cover can result in penetration of liquids into the foam, not only potentially
affecting its performance, but also increasing the risk of cross contamination.
The type of bedframe, or support, onto which the APTI is placed potentially affects the performance of
the final product. Overall product dimensions need to be taken into account not only to ensure that the
APTI can function correctly, but also to ensure that no entrapment hazards are created between the
frame and the APTI.
vi © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
TECHNICAL REPORT ISO/TR 20342-7:2021(E)
Assistive products for tissue integrity when lying down —
Part 7:
Foam properties, characteristics and performance
1 Scope
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.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
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 20342-1, Assistive products for tissue integrity when lying down — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20342-1 and the following
apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
assistive product for tissue integrity
APTI
surface intended to protect body tissue, designed to interface with the body when lying down or in
adjusted position
[SOURCE: ISO 20342-1:2019, 3.5]
3.2
bottoming out
insufficient support provided by an assistive product for tissue integrity (3.1) for the mass of patient
concerned, at the place where the assistive product for tissue integrity is no longer capable of
redistributing the pressure applied
Note 1 to entry: Localized pressure risks are now placed onto the patient by the bed frame or support surface
onto which the assistive product for tissue integrity has been placed.
3.3
destructive test
test method resulting in damage or destruction of the sample being tested
Note 1 to entry: The preparation of this test part renders an assistive product for tissue integrity (3.1) unsuitable
for use afterwards.
3.4
Dunlop process
action where foamed liquid latex is poured into a mould before vulcanization (3.10)
Note 1 to entry: Continuous production [see slabstock foam (3.11.6)] using the Dunlop process is also possible.
3.5
elongation
length of elongation at the rupture point as a percentage of the original length
3.6
tensile strength
force necessary to rupture the foam (3.11) when pulled by opposite forces
3.7
hydrolysis
chemical reaction in which the interaction of a compound with water results in the gradual
decomposition of that compound
2 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
kSIST-TP FprCEN ISO/TR 20342-7:2022
ISO/TR 20342-7:2021(E)
3.8
non-destructive test
test method that can be carried out without damaging the sample being tested
Note 1 to entry: An assistive product for tissue integrity (3.1) is not significantly altered by the test and is deemed
suitable for use afterwards.
3.9
Talalay process
action where foamed liquid latex is poured into a mould then placed under vacuum before vulcanization
(3.10)
3.10
vulcanization
chemical cross linking of rubber-based polymers to increase product rigidity and durability
3.11
foam
flexible cellular material in which the cells are all or partly intercommunicating
3.11.1
high resilience foam
HR foam
foam (3.11) characterized by higher elasticity, measured by ball rebound or comfort factor (SAG factor),
as compared with standard polyether polyurethane foams
Note 1 to entr
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.