oSIST prEN ISO 20342-1:2022

Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO/FDIS 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.

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)

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/FDIS 20342-1:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 24-May-2022
• ICS: 11.180.01 - Aids for disabled and handicapped persons in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 15-Mar-2022
• Due Date: 02-Aug-2022
• Ref Project: prEN ISO 20342-1 - Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO/FDIS 20342-1:2022)

RELATIONS

• Revised: SIST EN ISO 20342-1:2019 - Assistive products for tissue integrity when lying down - Part 1: General Requirements (ISO 20342-1:2019)
• Effective Date: 01-Dec-2021

Standards Content (sample)

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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
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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

iii
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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

© ISO 2022 – All rights reserved
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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.
© ISO 2022 – All rights reserved
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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.
© ISO 2022 – All rights reserved
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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,
© ISO 2022 – All rights reserved
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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
...