Assistive products - General requirements and test methods (ISO/FDIS 21856:2021)

This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE   Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.

Hilfsmittel - Allgemeine Anforderungen und Prüfverfahren (ISO/DIS 21856:2020)

Dieses Dokument legt allgemeine Anforderungen und Prüfverfahren für Hilfsmittel fest, die Medizinprodukte sind und zur Linderung oder zum Ausgleich einer Behinderung eingesetzt werden.
Dieses Dokument gilt nicht für Hilfsmittel, deren Zweckbestimmung es ist, dem Anwender pharmazeutische Substanzen zu verabreichen.
ANMERKUNG 1 Hilfsmittel gelten nur in bestimmten Ländern als Medizinprodukt.
ANMERKUNG 2 Anforderungen und Prüfverfahren für bestimmte Hilfsmitteltypen werden in anderen Internationalen Normen behandelt, siehe z. B. Verweisung [33].
ANMERKUNG 3 Nicht alle der in ISO 9999 aufgeführten Gegenstände sind Medizinprodukte. Vertragspartner können erwägen, ob dieses Dokument oder bestimmte Abschnitte oder Unterabschnitte davon zur Festlegung von Hilfsmitteln, die nicht als Medizinprodukte eingestuft sind, herangezogen werden können.

Produits d’assistance - Exigences générales et méthodes d’essai (ISO/DIS 21856:2020)

Tehnični pripomočki - Splošne zahteve in preskusne metode (ISO/FDIS 21856:2021)

General Information

Status
Not Published
Public Enquiry End Date
19-May-2020
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
13-May-2021
Due Date
01-Jul-2021
Completion Date
28-May-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 21856:2020
01-maj-2020
Tehnični pripomočki - Splošne zahteve in preskusne metode (ISO/DIS 21856:2020)
Assistive products - General requirements and test methods (ISO/DIS 21856:2020)
Hilfsmittel - Allgemeine Anforderungen und Prüfverfahren (ISO/DIS 21856:2020)

Produits d’assistance - Exigences générales et méthodes d’essai (ISO/DIS 21856:2020)

Ta slovenski standard je istoveten z: prEN ISO 21856
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
oSIST prEN ISO 21856:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 21856:2020
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oSIST prEN ISO 21856:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21856
ISO/TC 173 Secretariat: SIS
Voting begins on: Voting terminates on:
2020-03-26 2020-06-18
Assistive products — General requirements and test
methods
Produits d’assistance — Exigences générales et méthodes d’essai
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 21856:2020(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 2020
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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................vi

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 4

4 General requirements ..................................................................................................................................................................................... 8

4.1 Risk analysis and management ................................................................................................................................................. 8

4.2 Intended performance and technical documentation ......... .................................................................................. 9

4.3 Clinical evaluation and investigation ................................................................................................................................... 9

4.4 Assistive products that can be dismantled ..................................................................................................................... 9

4.5 Fasteners ...................................................................................................................................................................................................... 9

4.6 Load limits .................................................................................................................................................................................................. 9

4.7 Immobilising means ........................................................................................................................................................................... 9

4.8 Usability ........................................................................................................................................................................................................ 9

4.8.1 Design requirements in relation to persons with cognitive impairment .....................10

4.8.2 Design requirements for persons with hearing impairments ...............................................10

4.8.3 Design guidelines in relation to accessibility .......................................................................................10

5 Materials ....................................................................................................................................................................................................................10

5.1 General ........................................................................................................................................................................................................10

5.2 Flammability ..........................................................................................................................................................................................10

5.2.1 General...................................................................................................................................................................................10

5.2.2 Upholstered parts, mattresses, bed bases, bedding and textiles .........................................11

5.2.3 Polymeric parts ..............................................................................................................................................................12

5.2.4 Wiring .....................................................................................................................................................................................12

5.3 Biocompatibility and toxicity ..................................................................................................................................................12

5.4 Contaminants and residues ......................................................................................................................................................12

5.4.1 General...................................................................................................................................................................................12

5.4.2 Substances which may leak from an assistive product in intended use and

in fault conditions ........................................................................................................................................................12

5.5 Infection and microbiological contamination ...........................................................................................................13

5.5.1 Introduction ......................................................................................................................................................................13

5.5.2 Cleaning and disinfection ......................................................................................................................................13

5.5.3 Machine washable Assistive Products ........................................................................................................13

5.5.4 Animal tissue ....................................................................................................................................................................14

5.6 Resistance to corrosion ................................................................................................................................................................15

6 Emitted sound and vibration ................................................................................................................................................................15

6.1 Noise and vibration ..........................................................................................................................................................................15

6.2 Sound levels and frequencies of audible warning devices .............................................................................15

6.3 Feedback ....................................................................................................................................................................................................15

7 Electromagnetic compatibility ...........................................................................................................................................................15

8 Electrical safety ...................................................................................................................................................................................................15

8.1 General ........................................................................................................................................................................................................15

8.2 Battery powered assistive products ..................................................................................................................................16

8.2.1 Charge level indicator ...............................................................................................................................................16

8.2.2 Design guidelines in relation to accessibility .......................................................................................16

8.3 Electrically heated blankets, pads and similar flexible heating appliances ....................................16

8.4 Ingress of liquids or particulate matter ..........................................................................................................................16

8.4.1 Ingress of liquids ...........................................................................................................................................................16

8.4.2 Ingress of particulate matter ..............................................................................................................................17

8.5 Pendant Controls ................................................................................................................................................................................17

9 Overflow, spillage, leakage, and ingress of liquids .........................................................................................................17

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9.1 Overflow ....................................................................................................................................................................................................17

9.1.1 Requirements ..................................................................................................................................................................17

9.1.2 Test method .......................................................................................................................................................................17

9.2 Spillage ........................................................................................................................................................................................................18

9.2.1 Requirements ..................................................................................................................................................................18

9.2.2 Test method .......................................................................................................................................................................18

9.3 Leakage .......................................................................................................................................................................................................18

9.4 Ingress of liquids ................................................................................................................................................................................18

9.4.1 Requirements ..................................................................................................................................................................18

9.4.2 Test method .......................................................................................................................................................................18

10 Surface temperature ......................................................................................................................................................................................18

11 Sterility ........................................................................................................................................................................................................................19

11.1 Sterility requirements ....................................................................................................................................................................19

11.2 Sterilization processes ..................................................................................................................................................................19

11.3 Maintenance of sterility in transit .......................................................................................................................................19

12 Safety of moving parts .................................................................................................................................................................................19

12.1 Squeezing ..................................................................................................................................................................................................19

12.2 Mechanical wear .................................................................................................................................................................................20

12.3 Emergency stopping functions...............................................................................................................................................20

13 Means to prevent falling out ..................................................................................................................................................................21

13.1 Protection against inadvertent user falls in relation to side rails ............................................................21

14 Prevention of traps for parts of the human body ............................................................................................................23

14.1 Holes and clearances ......................................................................................................................................................................23

14.2 V-shaped openings ............................................................................................................................................................................24

15 Folding and locking mechanisms .....................................................................................................................................................24

15.1 General ........................................................................................................................................................................................................24

15.2 Locking mechanisms .......................................................................................................................................................................24

15.3 Prevention of trap and squeeze hazards........................................................................................................................24

16 Carrying handles ...............................................................................................................................................................................................25

16.1 General ........................................................................................................................................................................................................25

16.2 Requirement ..........................................................................................................................................................................................25

16.3 Test method ............................................................................................................................................................................................25

17 Assistive products which support or suspend users ....................................................................................................26

17.1 General ........................................................................................................................................................................................................26

17.2 Static forces .............................................................................................................................................................................................26

17.2.1 Assistive products which support users .................. .................................................................................26

17.2.2 Assistive products which suspend users .................................................................................................26

17.3 Dynamic forces .....................................................................................................................................................................................27

17.4 Requirements and test method for tips ..........................................................................................................................27

17.4.1 General...................................................................................................................................................................................27

17.4.2 Friction of tips .................................................................................................................................................................27

17.4.3 Durability of tips ...........................................................................................................................................................27

18 Assistive products / parts of assistive products on purpose-built devices ..........................................27

18.1 Ascending step shock: ....................................................................................................................................................................28

18.2 Descending step shock: ................................................................................................................................................................28

18.3 Door frame shock: .............................................................................................................................................................................28

19 Surfaces, corners, edges and protruding parts ..................................................................................................................29

20 Hand held assistive products ................................................................................................................................................................29

21 Small parts ...............................................................................................................................................................................................................29

22 Stability .......................................................................................................................................................................................................................29

23 Forces in soft tissues of the human body ..................................................................................................................................30

iv © ISO 2020 – All rights reserved
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24 Ergonomic principles ...................................................................................................................................................................................30

25 Requirements for information supplied by the manufacturer .........................................................................30

25.1 General ........................................................................................................................................................................................................30

25.2 Instructions for use ..........................................................................................................................................................................31

25.2.1 Pre-sale information ..................................................................................................................................................31

25.2.2 User information ...........................................................................................................................................................31

25.2.3 Service information ....................................................................................................................................................32

25.3 Labelling ....................................................................................................................................................................................................33

26 Packaging ..................................................................................................................................................................................................................33

27 Test report ................................................................................................................................................................................................................34

28 Guidelines for accessible information on assistive products .............................................................................34

Annex A (informative) Cognitive impairment ..........................................................................................................................................35

Annex B (informative) General Recommendations ............................................................................................................................36

Annex C (informative) Environmental and consumer related guidance ......................................................................44

Annex D Guidelines for accessible information on assistive products ........................................................................50

Bibliography .............................................................................................................................................................................................................................54

© ISO 2020 – All rights reserved v
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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(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 meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information. The committee

responsible for this document is ISO/TC 173, Assistive products for persons with disability.

ISO 21856 was prepared by ISO/TC 173, Assistive Products for persons with disability which is in line

with EN 12182 Assistive Products for persons with disability - General Requirements and Test methods.

This document supersedes ISO 16201 (E).
vi © ISO 2020 – All rights reserved
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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(E)
Introduction

This International Standard specifies general requirements and test methods that are relevant to

assistive products for persons with disability. This Standard does not apply to assistive products which

achieve their intended purpose by administering pharmaceutical substances to the user.

This document specifies general requirements and related test methods that are relevant to assistive

products in different application environments such as hospitals, home care, and institutions. Some of

the devices can apply in more than one application environment. This means that different requirements

and test methods can apply to the same assistive product depending on the application environment. To

conform with this document, all relevant clauses need to be fulfilled, depending on the type of assistive

product. For example, some assistive products do not include electrical components; therefore, the

clauses related to electrical components might not be relevant.

In addition to the requirements in this International Standard, Annex A provides cognitive impairment

information, Annex B gives general recommendations, Annex C gives environmental and consumer

related guidance and Annex D provides guidelines for accessible information on assistive products.

© ISO 2020 – All rights reserved vii
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oSIST prEN ISO 21856:2020
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oSIST prEN ISO 21856:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 21856:2020(E)
Assistive products — General requirements and test
methods
1 Scope

This International Standard specifies general requirements and test methods for assistive products

intended for use to alleviate or compensate for a disability.

The aim of this International Standard is to provide safety requirements and recommendations for

manufacturers of such assistive products.

This International Standard does not apply to assistive products which achieve their intended purpose

by administering pharmaceutical substances to the user.

Where other International Standards exist for particular types of assistive products then those

standards apply.

NOTE 1 Assistive products may be considered to be medical devices in some jurisdictions but not in others.

NOTE 2 Not all the items list
...

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