SIST EN ISO 21856:2022
(Main)Assistive products - General requirements and test methods (ISO 21856:2022)
Assistive products - General requirements and test methods (ISO 21856:2022)
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 21856:2022)
Dieses Dokument legt allgemeine Anforderungen und Prüfverfahren für Hilfsmittel fest, die als Medizinprodukte angesehen werden und zur Linderung oder zum Ausgleich einer Behinderung eingesetzt werden.
Dieses Dokument ist nicht anwendbar für Hilfsmittel, deren Zweckbestimmung es ist, dem Anwender pharmazeutische Substanzen zu verabreichen.
ANMERKUNG 1 Hilfsmittel gelten in einigen Rechtsordnungen als Medizinprodukte, in anderen nicht.
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 21856:2022)
Le présent document spécifie les exigences générales et les méthodes d’essai applicables aux produits d’assistance, considérés comme des dispositifs médicaux, destinés à soulager ou à compenser une incapacité.
Le présent document ne s’applique pas aux produits d’assistance dont la destination implique d’administrer à l’utilisateur des substances pharmacologiques.
NOTE 1 Les produits d’assistance sont considérés comme des dispositifs médicaux dans certaines régions, mais pas dans d’autres.
NOTE 2 Les exigences et les méthodes d’essai relatives à des types de produits d’assistance précis sont fournies dans d’autres Normes internationales, voir par exemple la Référence [33].
NOTE 3 Les articles énumérés dans l’ISO 9999 ne sont pas tous des dispositifs médicaux. Les parties contractantes peuvent souhaiter réfléchir à l’utilisation éventuelle du présent document, ou certains articles ou paragraphes peuvent être utilisés pour des produits d’assistance qui ne sont pas des dispositifs médicaux.
Tehnični pripomočki - Splošne zahteve in preskusne metode (ISO 21856:2022)
Ta evropski standard določa splošne zahteve in preskusne metode za tehnične pripomočke za invalidne osebe, ki so medicinski pripomočki v skladu z opredelitvijo iz Direktive 93/42/EGS.
Ta evropski standard se ne uporablja za tehnične pripomočke, katerih predvideni namen je dovajanje farmacevtskih sredstev uporabniku.
Kadar v zvezi s posebnimi vrstami tehničnih pripomočkov obstajajo drugi evropski standardi, se uporabljajo slednji. Vendar lahko še vedno veljajo nekatere zahteve iz tega standarda in se upoštevajo poleg zahtev iz drugih evropskih standardov.
OPOMBA: Nekateri pripomočki, ki so navedeni v standardu EN ISO 9999, niso medicinski pripomočki. Pogodbene stranke lahko preučijo, ali je ta standard oziroma dele tega standarda mogoče uporabiti za tehnične pripomočke, ki v Direktivi EU 93/42/EGS niso opredeljeni kot medicinski pripomočki.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21856:2022
01-september-2022
Nadomešča:
SIST EN 12182:2012
SIST EN ISO 16201:2006
Tehnični pripomočki - Splošne zahteve in preskusne metode (ISO 21856:2022)
Assistive products - General requirements and test methods (ISO 21856:2022)
Hilfsmittel - Allgemeine Anforderungen und Prüfverfahren (ISO 21856:2022)
Produits d’assistance - Exigences générales et méthodes d’essai (ISO 21856:2022)
Ta slovenski standard je istoveten z: EN ISO 21856:2022
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
SIST EN ISO 21856:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 21856:2022
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SIST EN ISO 21856:2022
EN ISO 21856
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 11.180.01 Supersedes EN ISO 16201:2006, EN 12182:2012
English Version
Assistive products - General requirements and test
methods (ISO 21856:2022)
Produits d'assistance - Exigences générales et Hilfsmittel - Allgemeine Anforderungen und
méthodes d'essai (ISO 21856:2022) Prüfverfahren (ISO 21856:2022)
This European Standard was approved by CEN on 29 July 2021.
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 21856:2022 E
worldwide for CEN national Members.
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SIST EN ISO 21856:2022
EN ISO 21856:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 21856:2022
EN ISO 21856:2022 (E)
European foreword
This document (EN ISO 21856:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 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 16201:2006 and EN 12182:2012.
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 21856:2022 has been approved by CEN as EN ISO 21856:2022 without any modification.
3
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SIST EN ISO 21856:2022
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SIST EN ISO 21856:2022
INTERNATIONAL ISO
STANDARD 21856
First edition
2022-07
Assistive products — General
requirements and test methods
Produits d’assistance — Exigences générales et méthodes d’essai
Reference number
ISO 21856:2022(E)
© ISO 2022
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SIST EN ISO 21856:2022
ISO 21856:2022(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
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 21856:2022
ISO 21856:2022(E)
Contents Page
Foreword . vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 General requirements . 7
4.1 Risk analysis and management. 7
4.2 Intended performance and technical documentation . 8
4.3 Clinical evaluation and investigation . 8
4.4 Assistive products that can be dismantled . 8
4.5 Fasteners . 8
4.6 Load limits . 8
4.7 Immobilising means . 9
4.8 Usability . 9
4.9 Design requirements in relation to persons with sensory and cognitive
impairments . 9
4.10 Considerations for accessibility . 9
4.11 Feedback . 9
5 Materials . 9
5.1 General . 9
5.2 Flammability . 9
5.2.1 General . 9
5.2.2 Upholstered parts, mattresses, bed bases, bedding and textiles . 10
5.2.3 Polymeric parts . 11
5.2.4 Electrical components . 11
5.2.5 Wiring . 11
5.3 Biocompatibility and toxicity . 11
5.4 Contaminants and residues . 12
5.4.1 General .12
5.4.2 Substances that can leak from an assistive product in intended use and in
fault conditions .12
5.5 Infection and microbiological contamination .12
5.5.1 Introduction . 12
5.5.2 Cleaning and disinfection .12
5.5.3 Machine washable assistive products .13
5.5.4 Animal tissue . 14
5.6 Resistance to corrosion . 14
6 Emitted sound and vibration .14
6.1 Noise and vibration . 14
6.2 Sound levels and frequencies of audible warning devices. 14
7 Electromagnetic compatibility .15
8 Electrical safety .15
8.1 General . 15
8.2 Battery powered assistive products - Charge level indicator . 15
8.3 Electrically heated blankets, pads and similar flexible heating appliances .15
8.4 Ingress of liquids or particulate matter . 15
8.4.1 Ingress of liquids . 15
8.4.2 Ingress of particulate matter . 16
8.5 Pendant controls . 16
9 Overflow, spillage, leakage and ingress of liquids .16
9.1 Overflow . 16
iii
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SIST EN ISO 21856:2022
ISO 21856:2022(E)
9.1.1 Requirements . 16
9.1.2 Test method . 16
9.2 Spillage . . 17
9.2.1 Requirements . 17
9.2.2 Test method . 17
9.3 Leakage . 17
9.4 Ingress of liquids . . . 17
9.4.1 Requirements . 17
9.4.2 Test method . 17
10 Surface temperature . .17
11 Sterility .18
11.1 Sterility requirements . 18
11.2 Sterilization processes . 18
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 .20
13.1 General . 20
13.2 Protection against inadvertent user falls in relation to side rails . 20
14 Prevention of traps for parts of the human body .22
14.1 Holes and clearances . 22
14.2 V-shaped openings . 23
15 Folding and locking mechanisms .23
15.1 General .23
15.2 Locking mechanisms . 23
15.3 Prevention of trap and squeeze hazards . 24
16 Carrying handles .24
16.1 General . 24
16.2 Requirement . 24
16.3 Test method . 24
17 Assistive products that support or suspend users .25
17.1 General . 25
17.2 Static forces . 25
17.2.1 Assistive products that support users . 25
17.2.2 Assistive products that suspend users . 26
17.3 Dynamic forces . 26
17.4 Requirements and test method for tips . . 26
17.4.1 General . 26
17.4.2 Friction of tips .26
17.4.3 Durability of tips . . 26
18 Portable and mobile assistive products.27
18.1 Portable assistive products . 27
18.2 Mobile assistive products . 27
19 Surfaces, corners, edges and protruding parts .28
20 Hand-held assistive products .28
21 Assistive products for children .29
22 Stability .29
23 Forces in soft tissues of the human body .30
24 Ergonomic principles .30
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SIST EN ISO 21856:2022
ISO 21856:2022(E)
25 Requirements for information supplied by the manufacturer .30
25.1 General .30
25.2 Instructions for use . 31
25.2.1 General . 31
25.2.2 Pre-sale information . 31
25.2.3 User information . 32
25.2.4 Service information . 32
25.3 Labelling . 33
26 Packaging.34
27 Test report .34
28 Guidelines for accessible information on assistive products .35
Annex A (informative) General recommendations .36
Annex B (informative) Environmental and consumer related guidance . 44
Annex C (informative) Guidelines for accessible information on assistive products .49
Bibliography .53
v
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SIST EN ISO 21856:2022
ISO 21856:2022(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 documen
...
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
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(E)
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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oSIST prEN ISO 21856:2020
ISO/DIS 21856:2020(E)
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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