EN ISO 21856:2022

Assistive products - General requirements and test methods (ISO 21856:2022)

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability.
This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
NOTE 1    Assistive products are considered to be medical devices in some jurisdictions but not in others.
NOTE 2    Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33].
NOTE 3    Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

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

• Status: Published
• Publication Date: 19-Jul-2022
• Withdrawal Date: 30-Jan-2023
• ICS: 11.180.01 - Aids for disabled and handicapped persons in general
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Jul-2022
• Completion Date: 20-Jul-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 21856:2022 - Assistive products - General requirements and test methods (ISO 21856:2022)

Relations

• Replaces: EN ISO 16201:2006 - Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
• Effective Date: 27-Jul-2022
• Replaces: EN 12182:2012 - Assistive products for persons with disability - General requirements and test methods
• Effective Date: 30-May-2018

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.

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 21856:2022(E)
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
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 .
...