SIST EN ISO 20342-1:2022
(Main)Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO 20342-1:2022)
Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO 20342-1:2022)
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.
18 12 15 Bedding such as but not limited to:
— draw sheets.
Hilfsmittel für die Gewebeintegrität im Liegen - Teil 1: Allgemeine Anforderungen (ISO 20342-1:2022)
Dieses Dokument legt allgemeine Anforderungen und zugehörige Prüfverfahren fest, die für Hilfsmittel für die Gewebeintegrität im Liegen (APTI, en: assistive products for tissue integrity) im Liegen in verschiedenen Anwendungsumgebungen, wie z. B. Krankenhäuser, häusliche Pflege und Einrichtungen, maßgeblich 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 (einschließlich einstellbarer) oder als ein ganzes integriertes System genutzt zu werden.
Dieses Dokument gilt nicht für medizinisch genutzte Betten.
Dieses Dokument erfasst auch Hilfsmittel, die in erster Linie für die Gewebeintegrität zur Änderung einer Liegeposition bzw. zur Aufrechterhaltung einer Liegeposition vorgesehen sind.
Dieses Dokument gilt weder für Flächen zur Liegeunterstützung, die in Kombination mit Inkubatoren oder OP-Tischen/Operationstischen verwendet werden.
Es umfasst auch Sicherheits- und Leistungsprüfverfahren zum Schutz vor Verletzungen des Benutzers.
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:— 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 zum Verlagern und Wenden, 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, welche 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 Strom 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, wie z. B., aber nicht beschränkt auf:
– Hilfsmittel zur Beinpositionierung;
– Armpositionierer und
– 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 20342-1:2022)
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 20342-1:2022)
Ta dokument določa splošne zahteve in zadevne preskusne metode, ki se navezujejo na tehnične pripomočke za celovitost tkiv (APTI) v ležečem položaju in njihovo uporabo v različnih okoljih, na primer v bolnišnicah, pri oskrbi na domu in v ustanovah. Ta dokument se uporablja za varnost tehničnih pripomočkov za celovitost tkiv, ki med ležanjem ostanejo na mestu uporabe in so namenjeni preprečevanju in/ali zdravljenju preležanin.
Ta dokument zajema nabor različnih površin za podporo pri ležanju, ki so namenjene uporabi skupaj z ustreznim podpornim podstavkom ali kot celovit integriran sistem.
Ta dokument zajema tudi tehnične pripomočke, ki so namenjeni predvsem za celovitost tkiv pri zamenjavi ležečega položaja, in tehnične pripomočke za ohranjanje ležečega položaja.
Ta mednarodni dokument se ne uporablja za površine za podporo pri ležanju, ki se uporabljajo skupaj z inkubatorji.
V tem dokumentu se obravnava kombinacija površine za podporo celotnega telesa in nastavljivega podpornega podstavka za vzmetnico. Zajema tudi preskusne metode za ugotavljanje varnosti in lastnosti za namene zagotavljanja zaščite uporabnika pred poškodbami.
Ta dokument določa zahteve in preskusne metode za tehnične pripomočke za celovitost tkiv v naslednjih klasifikacijah standarda ISO 9999:2016:
04-33-06 Tehnični pripomočki za celovitost tkiv v ležečem položaju, med drugim:
– vzmetnice in nadvzmetnice za preprečevanje preležanin;
– prevleke za vzmetnice za preprečevanje preležanin.
1231-03 Tehnični pripomočki za drsenje in obračanje, med drugim:
pripomočki za spreminjanje položaja ali lege osebe s tehnikami drsenja ali obračanja. Vključeni so samo izdelki, ki so namenjeni za uporabo v ležečem položaju in ostanejo na mestu uporabe kot del površine za podporo pri ležanju. To so:
– drsni izdelki, ki drsijo v eno smer in se zaskočijo 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 ne vključuje drsnih plošč, razen če je izdelek zasnovan tako, da se pusti na mestu uporabe.
09-07-06 Pozicijski vzglavniki, pozicijske blazine in pozicijski sistemi, med drugim:
– pripomočki za pozicioniranje nog;
– pripomočki za pozicioniranje rok; in
– večnamenski pripomočki za pozicioniranje telesa.
18 12 15 Posteljnina, med drugim:
– rjuhe obračalke.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20342-1:2022
01-oktober-2022
Nadomešča:
SIST EN ISO 20342-1:2019
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve
(ISO 20342-1:2022)
Assistive products for tissue integrity when lying down - Part 1: General requirements
(ISO 20342-1:2022)
Hilfsmittel für die Gewebeintegrität im Liegen - Teil 1: Allgemeine Anforderungen (ISO
20342-1:2022)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences
générales (ISO 20342-1:2022)
Ta slovenski standard je istoveten z: EN ISO 20342-1:2022
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
SIST EN ISO 20342-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20342-1:2022
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SIST EN ISO 20342-1:2022
EN ISO 20342-1
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 11.180.01 Supersedes EN ISO 20342-1:2019
English Version
Assistive products for tissue integrity when lying down -
Part 1: General requirements (ISO 20342-1:2022)
Produits d'assistance pour l'intégrité des tissus en Hilfsmittel für die Gewebeintegrität im Liegen - Teil 1:
position allongée - Partie 1: Exigences générales (ISO Allgemeine Anforderungen (ISO 20342-1:2022)
20342-1:2022)
This European Standard was approved by CEN on 26 June 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20342-1:2022 E
worldwide for CEN national Members.
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SIST EN ISO 20342-1:2022
EN ISO 20342-1:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20342-1:2022
EN ISO 20342-1:2022 (E)
European foreword
This document (EN ISO 20342-1:2022) 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 February 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
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.
This document supersedes EN ISO 20342-1:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20342-1:2022 has been approved by CEN as EN ISO 20342-1:2022 without any
modification.
3
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SIST EN ISO 20342-1:2022
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SIST EN ISO 20342-1:2022
INTERNATIONAL ISO
STANDARD 20342-1
Second edition
2022-07
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 20342-1:2022(E)
© ISO 2022
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(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 . 8
4.2.1 General requirements . 8
4.2.2 Consideration regarding intended use . 8
4.2.3 Intended use statement . 8
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 . 9
4.5 Design controls. 9
4.6 Clinical evaluation . 9
4.7 Foreseeable misuse . 9
4.8 Test conditions . 10
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 . 11
5.1.3 Education and training . 11
5.1.4 Pre-sale information . 11
5.1.5 User information .12
5.1.6 Service information and inspection . 13
5.1.7 Labelling . 13
5.1.8 Marking of user weight and maximum load .13
5.1.9 Packaging . 14
5.2 APTI that can be dismantled . . 14
5.2.1 General requirements . 14
5.2.2 Small parts . 14
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 .15
5.6 Default indicators . 15
5.7 Feedback . 16
6 Flammability .16
6.1 General . 16
6.2 Flammability . 17
6.3 Moulded parts used as enclosures for electrical equipment . 17
7 Mechanical safety .17
7.1 Prevention of traps for the human body . . 17
7.2 Safety of moving and folding parts . 18
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. 20
7.7 Temperature of parts that come into contact with human skin . 20
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(E)
7.8 Ergonomic principles . 21
7.9 Additional consideration . 21
8 Safety of electrical equipment . .21
8.1 General electrical requirements . 21
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
8.3 Liquid ingress . 22
8.4 Interruption of power supply/supply mains to an APTI . 23
8.5 Hold to run activation .23
8.6 Emergency stop functions . 23
9 Biocompatibility .24
9.1 Biocompatibility and toxicity . 24
9.2 Animal tissue . 24
10 Contamination .24
10.1 Liquid ingress . 24
10.2 Cleaning and disinfection . 24
10.3 Cross infection and microbial contamination . 25
Annex A (informative) General information .26
Annex B (informative) Environmental and consumer related guidance .30
Annex C (informative) Periodic inspection .34
Bibliography .35
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(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).
This second edition cancels and replaces the first edition (ISO 20342-1:2019), which has been technically
revised.
The main changes are as follows:
— the Scope was clarified;
— Clause 2 was updated;
— Clause 3 was updated;
— subclause 7.3 about V-shaped openings was amended;
— subclause 7.7 and Table 4 were amended (regarding surface temperature);
— the bibliography was updated.
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.
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(E)
Introduction
This document addresses Assistive Products for Tissue Integrity (APTI). As some devices can be used/
reused in more than one application environment, different requirements and test methods can apply
to the same APTI, depending on the application environment.
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.
[24]
Guidance can be found in the NPUAP/EPUAP/PPPIA Guidelines .
Surfaces applied on operating theatre tables can also impact in the process of patient management
and might 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.
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SIST EN ISO 20342-1:2022
INTERNATIONAL STANDARD ISO 20342-1:2022(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 that 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 (adjustable included) or as a whole integrated system.
This document does not apply to medical beds.
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 or
operating/surgical tables.
It also covers safety and performance test methods to ensure protection against injuries to the user.
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 9999:2022:
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, and
— mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to the following:
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,
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SIST EN ISO 20342-1:2022
ISO 20342-1:2022(E)
— arm positioners, and
— multipurpose body positioners.
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 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 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 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 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 —
...
SLOVENSKI STANDARD
oSIST prEN ISO 20342-1:2022
01-maj-2022
Tehnični pripomočki za celovitost tkiv v ležečem položaju - 1. del: Splošne zahteve
(ISO/FDIS 20342-1:2022)
Assistive products for tissue integrity when lying down - Part 1: General requirements
(ISO/FDIS 20342-1:2022)
Unterstützende Produkte zur Gewebeintegrität im Liegen - Teil 1: Allgemeine
Festlegungen (ISO/FDIS 20342-1:2022)
Produits d'assistance pour l'intégrité des tissus en position allongée - Partie 1: Exigences
générales (ISO/FDIS 20342-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 20342-1
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
oSIST prEN ISO 20342-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 20342-1:2022
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oSIST prEN ISO 20342-1:2022
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 20342-1
ISO/TC 173
Assistive products for tissue integrity
Secretariat: SIS
when lying down —
Voting begins on:
2022-03-02
Part 1:
Voting terminates on:
General requirements
2022-05-25
Produits d'assistance pour l'intégrité des tissus en position
allongée —
Partie 1: Exigences générales
IMPORTANT — Please use this updated version dated
2022-02-17, and discard any previous version of this FDIS.
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 20342-1:2022(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2022
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(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 . 8
4.2.1 General requirements . 8
4.2.2 Consideration regarding intended use . 8
4.2.3 Intended use statement . 8
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 . 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 . 11
5.1.3 Education and training . 11
5.1.4 Pre-sale information . 11
5.1.5 User information .12
5.1.6 Service information and inspection . 13
5.1.7 Labelling . 13
5.1.8 Marking of user weight and maximum load .13
5.1.9 Packaging . 13
5.2 APTI that can be dismantled . . 14
5.2.1 General requirements . 14
5.2.2 Small parts . 14
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 . 16
6 Flammability .16
6.1 General . 16
6.2 Flammability . 16
6.3 Moulded parts used as enclosures for electrical equipment . 17
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
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(E)
7.8 Ergonomic principles . 21
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 .22
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 . 23
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 .26
Annex B (informative) Environmental and consumer related guidance .30
Annex C (informative) Periodic inspection .34
Bibliography .35
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(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).
This second edition cancels and replaces the first edition (ISO 20342-1:2019), which has been technically
revised.
The main changes are as follows:
— the Scope was clarified;
— Clause 2 was updated;
— Clause 3 was updated;
— subclause 7.3 about V-shaped openings was amended;
— subclause 7.7 and Table 4 were amended (regarding surface temperature);
— the bibliography was updated.
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.
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(E)
Introduction
This document addresses Assistive Products for Tissue Integrity (APTI). As some devices can be used/
reused in more than one application environment, different requirements and test methods can apply
to the same APTI, depending on the application environment.
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.
[25]
Guidance can be found in the NPUAP/EPUAP/PPPIA Guidelines .
Surfaces applied on operating theatre tables can also impact in the process of patient management
and might 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.
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oSIST prEN ISO 20342-1:2022
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 20342-1:2022(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 that 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 (adjustable included) or as a whole integrated system.
This document does not apply to medical beds.
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 or
operating/surgical tables.
It also covers safety and performance test methods to ensure protection against injuries to the user.
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:—:
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, and
— mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to the following:
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,
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(E)
— arm positioners, and
— multipurpose body positioners.
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 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 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 14971, Medical devices — Application of risk management to medical devices
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)
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oSIST prEN ISO 20342-1:2022
ISO/FDIS 20342-1:2022(E)
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 62366, Medical devices — Part 1: Application of usability engineering to medical devices
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 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 Commission, MEDDEV 2.7/1 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND
NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
application environment 4
care provided in a domestic area where the assistive product for tissue integrity (3.5) is used to alleviate
or compensate for an injury, disability or disease
Note 1 to entry: This excludes use in all other application environments (e.g. nursing homes, rehabilitation
and geriatric facilities) when an assistive product for tissue integrity (3.5) is purely designed for application
environment 4.
[SOURCE: IEC 60601-2-52:2009+AMD1: 2015, 201.3.204, modified — "assistive product for tissue
integrity" replaced "ME equipment".]
3.2
applied part
part of the assistive product for tissue integrity
...
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