SIST EN ISO 20342-1:2019
(Main)Assistive products for tissue integrity when lying down - Part 1: General Requirements (ISO 20342-1:2019)
Assistive products for tissue integrity when lying down - Part 1: General Requirements (ISO 20342-1:2019)
This international standard applies to safety and performance of products intended to redistribute the load of the full body
during periods of lying and to prevent and or treat pressure sores and injuries.
This international standard will cover a range of different lying support surfaces intended to be used in combination
with e.g. a medical bed, stretcher, trolley, operating theatre table or as a whole integrated system.
This international standard also covers assistive products primarily intended for tissue integrity for changing a lying position
and assistive products for maintaining a lying position.
This international standard does not apply to lying support surfaces used in combination with incubators.
This international standard will also consider the combination of a full body support surface and an adjustable
mattress support platform. The following aspects will be covered: ‐ safety, ‐ performance test methods and
recommendations for clinical relevance ‐ protection against injuries to the patients/disabled persons.
This international standard specifies requirements and test methods for assistive products within the following
divisions of ISO 9999:2011:
04 33 06 Assistive products for tissue integrity when lying down, included are:
‐ Mattresses and mattress overlays for pressure‐sore prevention;
‐ Mattress coverings for pressure‐sore prevention mattresses;
12 31 03 Sliding boards, sliding mats and turning sheets. Only included are the following products
intended to be used in a lying position and to remain in situ as part of the lying support surface:
‐ Sliding products that glide one way and lock the other way;
‐ Sheets and underlays in flexible materials with low friction;
‐ Fabric sold by the meter, cut as required for repositioning use;
‐ Powered turning products;
This excludes: Sliding boards;
Note: The title and explanation of 12 31 03 will be changed in the 2016 ed. of ISO 9999 to:
Assistive products for sliding and turning. (Devices for changing position or direction of a person using sliding and
turning techniques. Included are, e.g. sliding boards, sliding mats, turning sheets, turning cushions.)
18 12 15 Bedding, only included are:
‐ Leg positioners;
‐ Multi purpose body positioners;
‐ Arm positioners;
‐ Draw sheets;
Note: In the 2016 ed. of ISO 9999 these products will be classified in 09 07 06 Positioning pillows, positioning
cushions and positioning systems. Only draw sheets will remain in 18 12 15.
This international standard only covers Part 1: General requirements. In order to ensure patient safety aspects.
The intention is to develop a series of standards to cover the broad range of issues related to the mattresses,
please see below for a non‐exhaustive list of areas to be covered. However, this part 1 only covers General requirements.
ISO 20342‐1 Assistive products for tissue integrity when lying down; Part 1: General requirements ISO 20342‐2 Assistive
products for tissue integrity when lying down; Part 2: Test methods for full body support surfaces for characteristics
related to tissue integrity (immersion and heat and water vapor
transmission characteristics)
ISO 20342‐3 Assistive products for tissue integrity when lying down; Part 3: Property test methods
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 1: Allgemeine Festlegungen (ISO 20342-1:2019)
Dieses Dokument legt allgemeine Anforderungen und zugehörige Prüfverfahren fest, die für Hilfsmittel für die Dekubitusprophylaxe (APTI en: assistive products for tissue integrity) im Liegen in verschiedenen Anwen-dungs¬umgebungen, wie z. B. Krankenhäusern, häusliche Pflege und Einrichtungen, relevant sind. Dieses Dokument gilt für die Sicherheit von APTI, die dazu bestimmt sind, während der Liegezeit an Ort und Stelle zu bleiben und Druckverletzungen zu verhindern und/oder zu behandeln.
Dieses Dokument erfasst eine Reihe von verschiedenen Flächen zur Liegeunterstützung, die dafür vorgesehen sind, in Kombination mit einer geeigneten Liegefläche oder als ein ganzes integriertes System genutzt zu werden.
Dieses Dokument erfasst auch Hilfsmittel, die in erster Linie für die Dekubitusprophylaxe zu Änderung einer Liegeposition bzw. zur Aufrechterhaltung einer Liegeposition vorgesehen sind.
Dieses Dokument gilt nicht für Flächen zur Liegeunterstützung, die in Kombination mit Inkubatoren verwendet werden.
Dieses Dokument behandelt die Kombination von Ganzkörper-Auflagefläche und einstellbarer Liegefläche (Lattenrost). Es umfasst auch Sicherheits- und Leistungsprüfverfahren zum Schutz vor Verletzungen des Benutzers.
Dieses Dokument legt die Anforderungen an und Prüfverfahren für APTI innerhalb der folgenden Einteilungen von ISO 9999:2016 fest.
04 33 06 Hilfsmittel für die Dekubitusprophylaxe beim Liegen, wie z. B., aber nicht beschränkt auf:
– Matratzen und Matratzenüberzüge zur Dekubitusprophylaxe;
– Matratzenbezüge für Matratzen zur Dekubitusprophylaxe.
12 31 03 Hilfsmittel zur Umlagerung und Wendung wie z. B., aber nicht beschränkt auf:
Vorrichtungen für das Umlagern oder den Positionswechsel einer Person unter Anwendung von Umlagerungs- oder Wendetechniken. Die einzigen enthaltenen Hilfsmittel sind die, die dafür vorgesehen sind, in einer Liegeposition verwendet zu werden und als Teil der Fläche zur Liegeunterstützung an Ort und Stelle zu bleiben. Es sind die folgenden:
– Hilfsmittel zum Umlagern, die in eine Richtung gleiten und in die andere verriegeln;
– Tücher und Unterlagen aus flexiblen Materialien mit geringer Reibung;
– als Meterware verkaufter Stoff, der so geschnitten wird, wie es für die Verwendung zur Umlagerung notwendig ist;
– mit Energie versorgte Hilfsmittel zum Wenden;
Ausgenommen davon sind Gleitbretter, es sei denn, das Hilfsmittel ist dazu bestimmt, an Ort und Stelle belassen zu werden.
09 07 06 Lagerungskissen, Lagerungspolster und Lagerungssysteme, z. B., aber nicht beschränkt auf:
– Hilfsmittel zur Beinpositionierung;
– Armpositionierer;
– Mehrzweck-Hilfsmittel zur Körperpositionierung.
18 12 15 Bettzeug wie z. B., aber nicht beschränkt auf:
– Stecklaken.
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences générales (ISO 20342-1:2019)
Le présent document spécifie des exigences générales et des méthodes d'essai associées applicables aux produits d'assistance pour l'intégrité des tissus (PAIT) en position allongée dans différents environnements d'application tels que les hôpitaux, les soins à domicile et les institutions. Le présent document s'applique à la sécurité des PAIT, qui sont destinés à rester in situ pendant les périodes d'alitement et à aider à prévenir et/ou à traiter les escarres.
Le présent document couvre une gamme de différentes surfaces d'alitement destinées à être utilisées en combinaison avec la structure porteuse appropriée ou en tant que système complet intégré.
Le présent document traite également de produits d'assistance principalement destinés à l'intégrité des tissus pour changer de position allongée et de produits d'assistance pour maintenir une position allongée.
Le présent document ne s'applique pas aux surfaces d'alitement utilisées en combinaison avec des incubateurs.
Le présent document traite de la combinaison d'un support de redistribution de la pression du corps entier et d'un sommier réglable. Il intègre également des méthodes d'essai de sécurité et de performance visant à assurer la protection de l'utilisateur contre toute blessure.
Le présent document spécifie des exigences et des méthodes d'essai pour les PAIT entrant dans le cadre des classifications suivantes de l'ISO 9999:2016:
04 33 06 Produits d'assistance pour l'intégrité des tissus en position allongée, tels que, sans toutefois s'y limiter:
— les matelas et surmatelas pour la prévention des escarres;
— les protège-matelas pour la prévention des escarres.
12 31 03 Produits d'assistance au glissement et produits d'assistance au retournement, tels que, sans toutefois s'y limiter:
les dispositifs permettant de modifier la position ou la direction d'une personne en utilisant des techniques de glissement ou des techniques de retournement. Les seuls produits inclus sont les produits destinés à être utilisés en position allongée et à rester in situ en tant que partie intégrante de la surface d'alitement. Ces produits sont les suivants:
— les produits de glissement qui coulissent dans un sens et se verrouillent dans l'autre sens;
— les planches et les supports en matériaux flexibles à faible frottement;
— le tissu vendu au mètre, découpé tel que requis pour une utilisation de repositionnement;
— les produits électriques de repositionnement.
Les planches de glissements sont exclues, à moins que le produit soit destiné à rester in situ.
09 07 06 Oreillers de positionnement, coussins de positionnement et systèmes de positionnement, tels que, sans toutefois s'y limiter:
— les dispositifs de positionnement des jambes;
— les dispositifs de positionnement des bras;
— les dispositifs de positionnement du corps polyvalents.
18 12 15 Literie, telle que, sans toutefois s'y limiter:
— les alèses.
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve (ISO 20342-1:2019)
Ta mednarodni standard se uporablja za varnost in zmogljivost izdelkov, namenjenih za porazdelitev obremenitve celotnega telesa med obdobji ležanja ter za preprečevanje in/ali zdravljenje preležanin in poškodb.
Ta mednarodni standard bo zajemal nabor različnih površin za podporo pri ležanju, ki so namenjene uporabi skupaj z npr. medicinsko posteljo, nosili, vozičkom, operacijsko mizo ali kot celovit integriran sistem.
Ta mednarodni standard zajema tudi tehnične pripomočke, ki so namenjeni predvsem za celovitost tkiv pri zamenjavi ležečega položaja, in tehnične pripomočke za ohranjanje ležečega položaja.
Ta mednarodni standard se ne uporablja za površine za podporo pri ležanju, ki se uporabljajo skupaj z inkubatorji.
Ta mednarodni standard bo obravnaval tudi kombinacijo površine za podporo celotnega telesa in nastavljivega podpornega podstavka za vzmetnico. Zajeti bodo naslednji vidiki: – varnost; – metode preskušanja zmogljivosti in priporočila za klinično ustreznost; – zaščita pred poškodbami bolnikov/invalidnih oseb.
Ta mednarodni standard določa zahteve in preskusne metode za tehnične pripomočke v naslednjih delih standarda ISO 9999:2011:
04 33 06 Tehnični pripomočki za celovitost tkiv v ležečem položaju, vključno z/s:
– vzmetnicami in nadvzmetnicami za preprečevanje preležanin;
– prevlekami za vzmetnice za preprečevanje preležanin;
12 31 03 Drsne deske, drsne podloge in podloge za obračanje. Vključeni so samo naslednji izdelki, ki so namenjeni za uporabo v ležečem položaju in ostanejo na mestu uporabe kot del površine za podporo pri ležanju:
– drsni izdelki, ki drsijo v eno smer in se zataknejo v drugi;
– rjuhe in podloge iz gibkih materialov z majhnim trenjem;
– metražne tkanine, ki se razrežejo po potrebi za uporabo pri premeščanju;
– električni izdelki za obračanje;
To izključuje: drsne deske;
Opomba: Naslov in razlaga razdelka 12 31 03 bo spremenjena v izdaji standarda ISO 9999 iz leta 2016 v:
Tehnični pripomočki za drsenje in obračanje. (Pripomočki za spreminjanje položaja ali lege osebe s tehnikami drsenja in obračanja. Vključene so npr. drsne deske, drsne podloge, podloge za obračanje, blazine za obračanje.)
18 12 15 Posteljnina, vključeni so samo:
– pripomočki za pozicioniranje nog;
– večnamenski pripomočki za pozicioniranje telesa;
– pripomočki za pozicioniranje rok;
– rjuhe obračalke;
Opomba: V izdaji standarda ISO 9999 iz leta 2016 bodo ti izdelki klasificirani v razdelku 09 07 06 Vzglavniki za pozicioniranje, blazine za pozicioniranje in sistemi za pozicioniranje. Razdelek 18 12 15 bo vključeval samo rjuhe obračalke.
Ta mednarodni standard zajema le 1. del: Splošne zahteve. Za namen zagotavljanja vidikov varnosti bolnikov.
Namen je razviti skupino standardov, ki bo zajemala številna vprašanja v zvezi z vzmetnicami; neizčrpen seznam zajetih področij je naveden v nadaljevanju. Vendar pa ta 1. del zajema samo splošne zahteve.
ISO 20342‐1, Tehnični pripomočki za celovitost tkiv v ležečem položaju; 1. del: Splošne zahteve
ISO 20342‐2 Assistive products for tissue integrity when lying down; Part 2: Test methods for full body support surfaces for characteristics related to tissue integrity (immersion and heat and water vapor transmission characteristics)
ISO 20342‐3 Assistive products for tissue integrity when lying down; Part 3: Property test methods
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20342-1:2019
01-oktober-2019
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve
(ISO 20342-1:2019)
Assistive products for tissue integrity when lying down - Part 1: General Requirements
(ISO 20342-1:2019)
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 1: Allgemeine
Festlegungen (ISO 20342-1:2019)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences
générales (ISO 20342-1:2019)
Ta slovenski standard je istoveten z: EN ISO 20342-1:2019
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
SIST EN ISO 20342-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20342-1:2019
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SIST EN ISO 20342-1:2019
EN ISO 20342-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 11.180.01
English Version
Assistive products for tissue integrity when lying down -
Part 1: General Requirements (ISO 20342-1:2019)
Produits d'assistance pour l'intégrité des tissus en Unterstützende Produkte zur Gewebeintegrität im
position allongée - Partie 1: Exigences générales (ISO Liegen - Teil 1: Allgemeine Festlegungen (ISO 20342-
20342-1:2019) 1:2019)
This European Standard was approved by CEN on 27 May 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20342-1:2019 E
worldwide for CEN national Members.
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SIST EN ISO 20342-1:2019
EN ISO 20342-1:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20342-1:2019
EN ISO 20342-1:2019 (E)
European foreword
This document (EN ISO 20342-1:2019) 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 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 20342-1:2019 has been approved by CEN as EN ISO 20342-1:2019 without any
modification.
3
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SIST EN ISO 20342-1:2019
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SIST EN ISO 20342-1:2019
INTERNATIONAL ISO
STANDARD 20342-1
First edition
2019-06
Assistive products for tissue integrity
when lying down —
Part 1:
General requirements
Produits d'assistance pour l'intégrité des tissus en position
allongée —
Partie 1: Exigences générales
Reference number
ISO 20342-1:2019(E)
©
ISO 2019
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements and safety . 7
4.1 General requirements . 7
4.2 Intended use . 7
4.2.1 General requirements . 7
4.2.2 Consideration regarding intended use . 7
4.2.3 Intended use statement . 8
4.3 APTI risk management. 8
4.4 APTI usability . 8
4.4.1 General. 8
4.4.2 Design requirements in relation to persons with cognitive impairment . 9
4.5 Design controls . 9
4.6 Clinical evaluation . 9
4.7 Foreseeable misuse . 9
4.8 Test conditions . 9
4.9 Lifting and carrying means.10
5 Safety requirements .10
5.1 Requirements for information supplied by the manufacturer .10
5.1.1 General.10
5.1.2 APTI traceability .10
5.1.3 Education and training .11
5.1.4 Pre-sale information .11
5.1.5 User information .11
5.1.6 Service information and inspection .12
5.1.7 Labelling .13
5.1.8 Marking of user weight and maximum load .13
5.1.9 Packaging.13
5.2 APTI which can be dismantled .13
5.2.1 General requirements .13
5.2.2 Small parts.13
5.2.3 Fasteners and connections .14
5.3 Resistance to corrosion .14
5.4 Noise and vibration .14
5.5 Sound audible acoustic energy .14
5.6 Default indicators .15
5.7 Feedback .15
6 Flammability .16
6.1 General .16
6.2 Flammability .16
6.3 Moulded parts used as enclosures for electrical equipment .16
7 Mechanical safety .17
7.1 Prevention of traps for the human body .17
7.2 Safety of moving and folding parts .17
7.3 V-shaped openings .19
7.4 Surfaces, corners, edges and protruding parts .19
7.5 Folding and adjusting mechanisms .19
7.6 Instability hazard .19
7.7 Temperature of parts that come into contact with human skin .20
© ISO 2019 – All rights reserved iii
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(E)
7.8 Ergonomic principles .20
7.9 Additional consideration .21
8 Safety of electrical equipment .21
8.1 General electrical requirements .21
8.2 Electromagnetic compatibility .21
8.2.1 General.21
8.2.2 Emissions .21
8.2.3 Immunity .21
8.2.4 Power frequency magnetic field immunity .21
8.3 Liquid ingress .22
8.4 Interruption of power supply/supply mains to an APTI .22
8.5 Hold to run activation .22
8.6 Emergency stop functions .22
9 Biocompatibility .23
9.1 Biocompatibility and toxicity .23
9.2 Animal tissue .23
10 Contamination .23
10.1 Liquid ingress .23
10.2 Cleaning and disinfection . .24
10.3 Cross infection and microbial contamination .24
Annex A (informative) General information.25
Annex B (informative) Environmental and consumer related guidance .29
Annex C (informative) Periodic inspection .33
Bibliography .34
iv © ISO 2019 – All rights reserved
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(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.
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.
© ISO 2019 – All rights reserved v
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(E)
Introduction
This document specifies general requirements that are relevant to 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/reused in more than one application environment.
This means that different requirements and test methods can apply to the same Assistive Products
for Tissue Integrity (APTI), depending on the application environment. For an APTI to conform with
this document, all relevant clauses need to be fulfilled, depending on the type of APTI. For example,
some APTI do not include electrical components; therefore, the clauses related to electrical components
might not be relevant.
APTI play a very important role in the prevention and treatment of pressure injuries. Another important
role in the prevention and treatment of pressure injury is the clinical practice and the clinical evaluation.
Guidance can be found in the NPUAP/EPUAP/PPPIA Guidelines, "Prevention and Treatment of Pressure
Ulcers: Clinical Practice Guideline,” from 2014.
Surfaces applied on operating theatre tables can also impact in the process of patient management
and may need to be taken into consideration. It should be recognized however, patient stability and
specialist equipment used during an operation often create conflicting priorities to those of an APTI.
Using this document, clinicians and manufacturers should consider the impact of other items (including
additional APTI) used in conjunction with an APTI on tissue integrity and safety.
This document only covers general requirements to ensure safety of users. However, the intention is to
develop a series of standards to cover the broad range of issues related to the APTI.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 20342-1:2019
INTERNATIONAL STANDARD ISO 20342-1:2019(E)
Assistive products for tissue integrity when lying down —
Part 1:
General requirements
1 Scope
This document specifies general requirements and related test methods that are relevant to assistive
products for tissue integrity (APTI) in the lying position in different application environments such as
hospitals, home care and institutions. This document applies to the safety of APTI, which are intended
to remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination
with the appropriate support platform or as a whole integrated system.
This document also covers assistive products primarily intended for tissue integrity for changing a
lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators.
This document addresses the combination of a full body support surface and an adjustable mattress
support platform. It also covers safety and performance test methods to ensure protection against
injuries to the user.
This document specifies requirements and test methods for APTI within the following classifications of
ISO 9999:2016:
04 33 06 Assistive products for tissue integrity when lying down such as but not limited to:
— Mattresses and mattress overlays for pressure injury prevention;
— Mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to:
Devices for changing position or direction of a person using sliding or turning techniques. The only
products included are those intended to be used in a lying position and remain in situ as part of the
lying support surface. They are the following:
— sliding products that glide one way and lock the other way;
— sheets and underlays in flexible materials with low friction;
— fabric sold by the metre, cut as required for repositioning use;
— powered turning product;
This excludes sliding boards unless the product is intended to be left in situ.
09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to:
— leg positioners,
— arm positioners, and
— multipurpose body positioners.
© ISO 2019 – All rights reserved 1
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SIST EN ISO 20342-1:2019
ISO 20342-1:2019(E)
18 12 15 Bedding such as but not limited to:
— draw sheets.
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 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 9614-1, Acoustics — Determination of sound power levels of noise sources using sound intensity —
Part 1: Measurement at discrete points
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
IEC 60601-1:2006, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60695-11-10, Fire hazard testing — Part 11-10: Test flames — 50 W horizontal and vertical flame
test methods
IEC 61000-3-2, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current
emissions (equipment input current ≤16 A per phase)
IEC 61000-3-3, Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage chang
...
SLOVENSKI STANDARD
oSIST prEN ISO 20342-1:2018
01-julij-2018
7HKQLþQLSULSRPRþNL]DFHORYLWRVWWNLYYOHåHþHPSRORåDMXGHO 6SORãQH]DKWHYH
,62',6
Assistive products for tissue integrity when lying down – Part 1: General Requirements
(ISO/DIS 20342-1:2018)
Unterstützende Produkte zur Gewebeintegrität im Liegen -Teil 1: Allgemeine
Festlegungen (ISO/DIS 20342-1:2018)
Produits dassistance à lintégrité des tissus en position allongée - Partie 1: Exigences
générales (ISO/DIS 20342-1:2018)
Ta slovenski standard je istoveten z: prEN ISO 20342-1
ICS:
11.180.01 3ULSRPRþNL]D Aids for disabled and
RQHVSRVREOMHQHLQ handicapped persons in
KHQGLNHSLUDQHRVHEHQD general
VSORãQR
oSIST prEN ISO 20342-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 20342-1:2018
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oSIST prEN ISO 20342-1:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20342-1
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:
2018-05-21 2018-08-13
Assistive products for tissue integrity when lying down —
Part 1:
General requirements
Produits d’assistance à l’intégrité des tissus en position couchée
ICS: 11.180.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20342-1:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements and safety . 8
4.1 General requirements . 8
4.2 Intended use . 8
4.2.1 General requirements . 8
4.2.2 Consideration regarding intended use . 8
4.2.3 Intended use statement . 9
4.3 APTI risk management. 9
4.4 APTI usability . 9
4.4.1 General. 9
4.4.2 Design requirements in relation to persons with cognitive impairment .10
4.5 Design controls .10
4.6 Clinical evaluation .10
4.7 Foreseeable misuse .10
4.8 Test conditions .10
4.9 Lifting and carrying means.11
5 Safety requirements .11
5.1 Requirements for information supplied by the manufacturer .11
5.1.1 General.11
5.1.2 APTI classification .11
5.1.3 APTI traceability .12
5.1.4 Education and training .12
5.1.5 Pre-sale information .12
5.1.6 User information .12
5.1.7 Service information and inspection .13
5.1.8 Labelling .14
5.1.9 Marking of user weight and maximum load .14
5.1.10 Packaging.14
5.2 APTI which can be dismantled .14
5.2.1 General requirements .14
5.2.2 Resistance to corrosion .14
5.2.3 Small parts.14
5.2.4 Fasteners and connections .15
5.3 Noise and vibration .15
5.4 Sound audible acoustic energy .15
5.5 Default indicators .16
5.6 Feedback .16
6 Flammability .16
6.1 General .16
6.2 Upholstered parts, mattresses, bed bases and bedding .17
6.3 Upholstered parts .17
6.4 Mattresses or overlay mattresses .17
6.5 Positioning systems .17
6.6 Bedding .17
6.7 Moulded parts used as enclosures for electrical equipment .18
7 Mechanical Safety .18
7.1 Prevention of traps for the human body .18
7.2 Safety of moving and folding parts .18
© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
7.3 V-shaped openings .20
7.4 Surfaces, corners, edges and protruding parts .20
7.5 Folding and adjusting mechanisms .20
7.6 Instability hazard .20
7.7 Temperature of parts that come in contact with human skin .21
7.8 Ergonomic principles .21
7.9 Additional consideration .22
8 Safety of electrical equipment .22
8.1 General electrical requirements .22
8.2 Electromagnetic compatibility .22
8.2.1 General.22
8.2.2 Emissions .22
8.2.3 Immunity .22
8.2.4 Power frequency magnetic field immunity .22
8.2.5 Liquid ingress .23
8.3 Interruption of power supply/supply mains to an APTI .23
8.4 Hold to run activation .23
8.5 Emergency stop functions .24
9 Biocompatibility .24
9.1 Biocompatibility and toxicity .24
9.2 Animal tissue .24
9.3 Contamination .24
9.3.1 Liquid Ingress .24
9.3.2 Cleaning and disinfection .25
9.3.3 Cross Infection and Microbial Contamination .25
9.3.4 Moisture Vapour Permeability/Microclimate Management .26
Annex A (informative) General information.27
Annex B (informative) Cognitive impairment .31
Annex C (informative) Environmental and consumer related requirements .32
Annex D (informative) Periodic inspection .37
Bibliography .38
iv © ISO 2018 – All rights reserved
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(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 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: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products for persons with
disability.
© ISO 2018 – All rights reserved v
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
Introduction
This document specifies general requirements and related test methods that are relevant to 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/reused in more than one
application environment. This means that different requirements and test methods can be applied to
the same APTI depending on the application environment. In order for an APTI to claim compliance
with this document, all relevant clauses need to be fulfilled, depending on the type of APTI. For example,
some APTI do not include electrical components; therefore, the clauses related to electrical components
may not be relevant.
APTI play a very important role in the prevention and treatment of pressure injuries. Another important
role in the prevention and treatment of pressure injury is the clinical practice and the clinical evaluation.
Good guidance can be found in the NPUAP/EPUAP/PPPIA Guidelines, "Prevention and Treatment of
Pressure Ulcers: Clinical Practice Guideline,” from 2014.
The intention is to develop a series of standards to cover the broad range of issues related to the APTI.
However, Part 1 only covers general requirements in order to ensure safety of participating persons.
vi © ISO 2018 – All rights reserved
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oSIST prEN ISO 20342-1:2018
DRAFT INTERNATIONAL STANDARD ISO/DIS 20342-1:2018(E)
Assistive products for tissue integrity when lying down —
Part 1:
General requirements
1 Scope
This document applies to the safety of APTI, which make claims to redistribute the load of the full body,
remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination
with the appropriate support platform or as a whole integrated system.
This document also covers assistive products primarily intended for tissue integrity for changing a
lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators.
This document will address the combination of a full body support surface and an adjustable mattress
support platform. Safety and performance test methods to ensure protection against injuries to the
user are the aspects that this document will cover.
This document specifies requirements and test methods for assistive products within the following
divisions of ISO 9999:2016:
04 33 06 Assistive products for tissue integrity (APTI) when lying down:
— Mattresses and mattress overlays for pressure injury prevention;
— Mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning:
Devices for changing position or direction of a person using sliding or turning techniques. Only included
are the following products intended to be used in a lying position and remain in situ as part of the lying
support surface:
— Sliding products that glide one way and lock the other way;
— Sheets and underlays in flexible materials with low friction;
— Fabric sold by the metre, cut as required for repositioning use;
— Powered turning product;
This excludes sliding boards.
09 07 06 Positioning pillows, positioning cushions and positioning systems e.g:
— Leg positioners;
— Arm positioners;
— Multipurpose body positioners.
18 12 15 Bedding:
— Draw sheets
© ISO 2018 – All rights reserved 1
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
NOTE Through the use of this document, clinicians and manufacturers should consider the impact of other
items (including additional APTI) used in conjunction with an APTI on tissue integrity and safety.
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 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 9614-1, Acoustics — Determination of sound power levels of noise sources using sound intensity —
Part 1: Measurement at discrete points
ISO 9999:2016, Assistive products for persons with disability — Classification and terminology
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 12952-1, Textiles — Assessment of the ignitability of bedding items — Part 1: Ignition source:
smouldering cigarette
ISO 12952-2, Textiles — Assessment of the ignitability of bedding items — Part 2: Ignition source: match-
flame equivalent
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17966:2016, Assistive products for personal hygiene that support users — Requirements and test methods
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60695-11-10, Fire hazard testing — Part 11-10: Test flames — 50 W horizontal and vertical flame
test methods
2 © ISO 2018 – All rights reserved
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oSIST prEN ISO 20342-1:2018
ISO/DIS 20342-1:2018(E)
IEC 61000-3-2, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current
emissions (equipment input current ≤16 A per phase)
IEC 61000-3-3, Electromagnetic compatibility (EMC) — Part 3-3: Limits – Limitation of voltage changes,
voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16
A per phase and not subject to conditional connection
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-8, Electromagnetic compatibility (EMC) — Part 4-8: Testing and measurement techniques —
Power frequency magnetic field immunity test
IEC 61672-1, Electroacoustics – Sound level meters — Part 1: Specifications
IEC 61672-2, Electroacoustics – Sound level meters — Part 2: Pattern evaluation tests
IEC 80601-2-35, Medical electrical equipment — Part 2-35: Particular requirements for the basic safety
and essential performance of heating devices using blankets, pads or mattresses and intended for heating
in medical use
EN 597-1, Furniture — Assessment of the ignitability of mattresses and upholstered bed bases — Part 1:
Ignition source smouldering cigarette
EN 597-2, Furniture — Assessment of the ignitability of mattresses and upholstered bed bases — Part 2:
Ignition source: match flame equivalent
EN 716-2:2017, Furniture — Children’s cots and folding cots for domestic use — Part 2: Test methods
EN 1041, Information supplied by the manufacturer of medical devices
CISPR 11, Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance
characteristics - Limits and methods of measurement
European Commision. MEDDEV 2.7/1 Guidelines on medical devices
RESNA. 2014: SS-1 American National Standard for Support Surfaces – Volume 1: Requirements and
Test Methods for Full Body Support Surfaces
WHO. 2001: International Classification of Functioning, Disability and Health ( ICF)
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:
...
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