SIST EN ISO 9999:2022
(Main)Assistive products - Classification and terminology (ISO 9999:2022)
Assistive products - Classification and terminology (ISO 9999:2022)
This document specifies a classification and terminology of assistive products, especially produced or
generally available, for persons to optimize functioning and reduce disability.
Assistive products used by a person to optimize functioning and reduce disability, but which require
the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this document:
— items used for the installation of assistive products;
— solutions obtained by combinations of assistive products that are individually classified in this
document;
— medicines;
— assistive products and instruments used exclusively by healthcare professionals or by teachers;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.
Hilfsmittel - Klassifikation und Terminologie (ISO 9999:2022)
Dieses Dokument legt eine Klassifikation und Terminologie für Hilfsmittel für Menschen fest, seien es Sonderanfertigungen oder Gebrauchsgüter, um die Funktionsfähigkeit zu verbessern und Einschränkungen zu vermindern.
Hilfsmittel, die von einem Menschen zur Verbesserung der Funktionsfähigkeit und Minderung von Einschränkungen verwendet werden, bei deren Verwendung jedoch die Unterstützung durch eine andere Person benötigt wird, sind in der Klassifikation enthalten.
Folgende Hilfen sind in diesem Dokument ausdrücklich nicht berücksichtigt:
— Geräte für die Installation von Hilfsmitteln;
— Lösungen, die auf einer Kombination von Hilfsmitteln, welche einzeln in diesem Dokument klassifiziert sind, beruhen;
— Arzneimittel;
— Hilfsmittel und Instrumente, die ausschließlich in der professionellen medizinischen Betreuung oder von Lehrern eingesetzt werden;
— nicht technische Lösungen wie persönliche Assistenz, Führhunde oder Lippenlesen;
— implantierte Geräte;
— finanzielle Förderung.
Produits d’assistance - Classification et terminologie (ISO 9999:2022)
Le présent document spécifie une classification ainsi qu’une terminologie des produits d’assistance, fabriqués spécialement ou existants sur le marché, dans le but d’optimiser le fonctionnement et de réduire l’incapacité des personnes.
Les produits d’assistance utilisés par une personne pour optimiser son fonctionnement et réduire son incapacité, qui nécessitent l’aide d’une autre personne pour les faire fonctionner, font partie de la classification.
Les articles suivants sont spécifiquement exclus du présent document:
— les articles utilisés pour l’installation des produits d’assistance;
— les solutions obtenues par la combinaison de produits d’assistance individuellement classés dans le présent document;
— les médicaments;
— les produits d’assistance et les instruments que seuls les professionnels de la santé ou les enseignants utilisent;
— les solutions non techniques, telles que l’assistance personnelle, les chiens guides d’aveugles ou la lecture labiale;
— les dispositifs implantés;
— l’aide financière.
Tehnični pripomočki - Razvrstitev in terminologija (ISO 9999:2022)
Ta dokument določa razvrstitev in terminologijo tehničnih pripomočkov, ki so posebej izdelani ali so
na splošno na voljo za optimiziranje funkcionalnosti ter zmanjšanje nezmožnosti oseb.
V razvrstitev so vključeni tudi tehnični pripomočki, ki jih oseba uporablja za optimiziranje funkcionalnosti in zmanjšanje
nezmožnosti, vendar je za njihovo delovanje potrebna pomoč še ene osebe.
Ta dokument izrecno ne vključuje naslednjih elementov:
– elementov, ki se uporabljajo za namestitev tehničnih pripomočkov;
– rešitev, pridobljenih z združitvijo posameznih tehničnih pripomočkov, ki so razvrščeni v tem
dokumentu;
– zdravil;
– tehničnih pripomočkov in instrumentov, ki jih uporabljajo izključno zdravstveni delavci ali učitelji;
– netehničnih rešitev, kot je osebna pomoč, psi vodniki ali branje z ustnic;
– vsajenih pripomočkov;
– finančne podpore.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9999:2022
01-september-2022
Nadomešča:
SIST EN ISO 9999:2017
Tehnični pripomočki - Razvrstitev in terminologija (ISO 9999:2022)
Assistive products - Classification and terminology (ISO 9999:2022)
Hilfsmittel - Klassifikation und Terminologie (ISO 9999:2022)
Produits d’assistance - Classification et terminologie (ISO 9999:2022)
Ta slovenski standard je istoveten z: EN ISO 9999:2022
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
SIST EN ISO 9999:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9999:2022
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SIST EN ISO 9999:2022
EN ISO 9999
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 11.180.01 Supersedes EN ISO 9999:2016
English Version
Assistive products - Classification and terminology (ISO
9999:2022)
Produits d'assistance - Classification et terminologie Hilfsmittel - Klassifikation und Terminologie (ISO
(ISO 9999:2022) 9999:2022)
This European Standard was approved by CEN on 18 March 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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 9999:2022 E
worldwide for CEN national Members.
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SIST EN ISO 9999:2022
EN ISO 9999:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 9999:2022
EN ISO 9999:2022 (E)
European foreword
This document (EN ISO 9999:2022) 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 2022.
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 9999:2016.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 9999:2022 has been approved by CEN as EN ISO 9999:2022 without any modification.
3
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SIST EN ISO 9999:2022
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SIST EN ISO 9999:2022
INTERNATIONAL ISO
STANDARD 9999
Seventh edition
2022-05
Assistive products — Classification
and terminology
Produits d’assistance — Classification et terminologie
Reference number
ISO 9999:2022(E)
© ISO 2022
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Elements and rules used in classification . 3
4.1 Principle . 3
4.2 Construction . 3
4.3 Codes . 3
4.4 Titles of classes, subclasses and divisions . 4
4.5 Rules used in classification . 4
5 Classification . 5
5.1 One-level classification — Classes . 5
5.2 Two-level classification — Classes and subclasses . 5
5.3 Three-level, detailed classification with explanations, inclusions, exclusions and
references . 10
Annex A (informative) Membership of ISO 9999 in the WHO Family of International
Classifications . 102
Annex B (informative) On the definition of assistive product . 103
Annex C (informative) Conversion table between ISO 9999:2016 (6th edition) and this
document (ISO 9999:2022, 7th edition) . 104
Annex D (informative) Alphabetical index . 138
Bibliography . 194
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SIST EN ISO 9999:2022
ISO 9999:2022(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, Subcommittee
SC 2, Classification and terminology, 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 seventh edition cancels and replaces the sixth edition (ISO 9999:2016), which has been technically
revised. The main changes are as follows:
— deletion of class 05 was;
— major changes in class 09, class 12 and class 22.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
Introduction
Assistive products (including software) are classified according to their function. The classification
consists of three hierarchical levels and the codes each consist of three pairs of digits. Like other
classifications, for each level, codes, titles, explanatory notes, inclusions, exclusions and cross-references
are given. Besides the explanatory text and the classification itself, a table of conversion between the
previous edition (ISO 9999:2016) and this document (ISO 9999:2022) and an alphabetical index are
provided in order to facilitate the use of and to improve the accessibility of the classification.
This document has 948 titles of which about 23 are new and 116 are changed, including minor editorial
revisions.
All assistive products in this classification are primarily intended for use outside of health care settings;
however, some of the products can be used in facilities such as rehabilitation centres to teach clients
how to use these products. It should be noted that the titles of some subclasses and divisions in class 28
refer to the “workplace”. This term does not refer to a specific setting or geographical location; instead,
it refers to any setting in which employment-related activities or vocational training are performed.
The definition of “assistive product” used by this document has been revised to align it with the
terminology of the International Classification of Functioning, Disability and Health (ICF, WHO, 2018).
In 2003, ISO 9999 was accepted as a related member of the WHO Family of International Classifications
(WHO-FIC). The WHO-FIC comprises high-quality classifications for relevant sectors of the health
system. With this inclusion, the use of this document was stimulated.
This document makes use of the terminology of the ICF, which is a classification of health and health-
related domains. These domains are classified from body, individual and societal perspectives by means
of two lists: a list of body functions and structure and a list of domains of activity and participation. Since
an individual's functioning and disability occurs in a context, ICF also includes a list of environmental
factors. Assistive products in this list are viewed as part of the environmental factors. The ICF is one of
the core classifications of the WHO-FIC (see Annex A).
An alphabetical index of terms in Annex D is provided for information to facilitate access to the
classification. Terms used in inclusion statements are incorporated in the index.
NOTE Some of the assistive products can be classified as medical devices.
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SIST EN ISO 9999:2022
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SIST EN ISO 9999:2022
INTERNATIONAL STANDARD ISO 9999:2022(E)
Assistive products — Classification and terminology
1 Scope
This document specifies a classification and terminology of assistive products, especially produced or
generally available, for persons to optimize functioning and reduce disability.
Assistive products used by a person to optimize functioning and reduce disability, but which require
the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this document:
— items used for the installation of assistive products;
— solutions obtained by combinations of assistive products that are individually classified in this
document;
— medicines;
— assistive products and instruments used exclusively by healthcare professionals or by teachers;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.
2 Normative references
There are no normative references in this document.
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
activity
execution of a task or action by an individual
[SOURCE: ICF 2018, WHO]
3.2
activity limitation
difficulties an individual can have in executing activities (3.1)
[SOURCE: ICF 2018, WHO]
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
3.3
assistive product
product that optimizes a person’s functioning and reduces disability
Note 1 to entry: See Annex B.
Note 2 to entry: Assistive products include devices, instruments, equipment, and software.
Note 3 to entry: Assistive products can be especially produced or generally available items.
3.4
body function
physiological functions of body systems (including psychological functions)
[SOURCE: ICF 2018, WHO]
3.5
body structure
anatomical parts of the body such as organs, limbs and their components
[SOURCE: ICF 2018, WHO]
3.6
disability
umbrella term for impairments (3.9), activity limitations (3.2) and participation restrictions (3.12)
denoting the negative aspects of the interaction between an individual (with a health condition) and
that individual’s contextual factors (environmental and personal factors)
[SOURCE: ICF 2018, WHO]
3.7
environmental factor
physical, social and attitudinal environment in which people live and conduct their lives
[SOURCE: ICF 2018, WHO]
3.8
functioning
umbrella term for body functions (3.4), body structures, activities (3.1) and participation (3.11) denoting
the positive aspects of the interaction between an individual (with a health condition) and that
individual’s contextual factors (environmental and personal factors)
[SOURCE: ICF 2018, WHO]
3.9
impairment
problems in body function or structure, such as a significant deviation or loss
[SOURCE: ICF 2018, WHO]
3.10
person with disability
person with one or more impairments (3.9), one or more activity limitations (3.2), one or more
participation restrictions (3.12) or a combination thereof
3.11
participation
involvement in a life situation
[SOURCE: ICF 2018, WHO]
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
3.12
participation restriction
problems an individual can experience in involvement in life situations
[SOURCE: ICF 2018, WHO]
3.13
workplace
setting in which employment-related activities or vocational training are performed
3.14
robot
programmed actuated mechanism with a degree of autonomy to perform locomotion, manipulation or
positioning
Note 1 to entry: A robot includes the control system and interface of the control system.
4 Elements and rules used in classification
4.1 Principle
The classification is based on the function of the products being classified.
Assistive products that have a principal function other than training, but which can also be used for
training, are included in the class covering their primary function.
Software is classified according to its function.
Multifunctional products are also classified based on the primary function. References may be added
related to secondary functions of the item.
4.2 Construction
The classification consists of three hierarchical levels: classes, subclasses and divisions.
Each class, subclass or division consists of a code, a title and, if necessary, an explanatory note and
reference to other parts of the classification.
Explanatory notes are used to clarify the content of the class, subclass or division. Inclusions and
exclusions are used to provide examples.
References are used for two purposes:
— to separate classes, subclasses or divisions from one another;
— for information, e.g. references between related products.
In general, references are made to the lowest possible level.
4.3 Codes
4.3.1 The code consists of three pairs of digits.
The first pair of digits indicates a class, the second pair of digits a subclass and the third pair of digits a
division.
For practical reasons, in this document, the classes are indicated by one pair of digits only (deleting two
pairs of zeros) and subclasses are indicated by two pairs of digits (deleting one pair of zeros).
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
The code determines the position of the class, the subclass or the division, respectively, in the
classification.
4.3.2 The digits for the codes were originally chosen with intervals of three. In subsequent revisions,
the intervening digits have been used to introduce new classes, subclasses and divisions without
significantly modifying the classification.
Codes that were originally used to classify items that have been removed from the classification are not
used to classify new items that have been added to the classification. As a consequence, the order of the
codes is no longer in all places in intervals of three and the divisions may not in all places follow a logic
order.
4.3.3 Classes 01, 02, and 90 to 99 and the associated subclasses and divisions are reserved for
national applications.
The subclasses XX 01, XX 02, and XX 90 to XX 99 and the associated divisions are reserved for national
applications.
The divisions XX XX 01, XX XX 02 and XX XX 90 to XX XX 99 are reserved for national applications.
Subclasses XX 88 and the divisions XX XX 88 are reserved for assistive products that are titled “Other
(title of parent class or parent subclass)” for international applications.
In addition, further levels, e.g. 4th level, may be added to any part of the classification to serve national
or local purposes
4.3.4 A conversion table detailing the coding changes from the previous edition (ISO 9999:2016) of
the classification to this document is given in Annex C.
4.4 Titles of classes, subclasses and divisions
4.4.1 The common language and framework of the ICF is used when appropriate, otherwise
terminology in general use has been adopted; titles of classes are harmonized with the ICF.
4.4.2 All titles in the classification are in the plural form.
4.4.3 Titles at class level generally describe a broad area of function of the product, e.g. assistive
products for domestic activities and participation in domestic life, assistive products for activities and
participation relating to personal mobility and transportation and assistive products for work activities
and participation in employment.
4.4.4 Titles at subclass level describe a special function, e.g. “assistive products for reading”, within
the broad area covered by the class, e.g. “assistive products for communication and information
management”.
4.4.5 Going down to the division level, the description gets more specific.
4.4.6 Only in cases where an assistive product is intended for use by persons with a specific disability,
age or gender should the title refer to that group.
4.5 Rules used in classification
4.5.1 A class is equal to the sum of its subclasses and a subclass is equal to the sum of its divisions.
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
4.5.2 In general, parts of assistive products, accessories to assistive products, individually adapted
assistive products and individual adaptations in homes and other premises are classified in the same
subclass or division of the assistive product with which they are associated.
4.5.3 Parts, accessories and adaptations are separately classified when they are associated with
a group of assistive products. In these cases, they are classified as close as possible to the group of
assistive products with which they are associated, e.g. 12 07 accessories for assistive products for
walking.
4.5.4 The classification is organized in such a manner that all assistive products can be classified
without being tested or measured.
4.5.5 Classification of hypothetical assistive products is avoided.
4.5.6 Classes are created in such a manner that they do not overlap in the described broad function
of other classes. The subclasses are created in such a manner that they do not overlap in the specific
function of other subclasses. The divisions are created in such a manner that they do not overlap with
products in other divisions.
5 Classification
5.1 One-level classification — Classes
04 Assistive products for measuring, stimulating or training physiological and psychological
functions
06 Orthoses and prostheses
09 Assistive products for self-care activities and participation in self-care
12 Assistive products for activities and participation relating to personal mobility and trans-
portation
15 Assistive products for domestic activities and participation in domestic life
18 Furnishings, fixtures and other assistive products for supporting activities in indoor and
outdoor human-made environments
22 Assistive products for communication and information management
24 Assistive products for controlling, carrying, moving and handling objects and devices
27 Assistive products for controlling, adapting or measuring elements of physical environments
28 Assistive products for work activities and participation in employment
30 Assistive products for recreation and leisure
5.2 Two-level classification — Classes and subclasses
04 Assistive products for measuring, stimulating or training physiological and psychological
functions
04 03 Assistive products for respiration
04 06 Assistive products for supporting and stimulating blood circulation
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
04 08 Assistive products for stimulating body control and conceptualization
04 09 Assistive products for light therapy
04 15 Assistive products for dialysis therapy
04 19 Assistive products for administering medicines
04 22 Sterilizing equipment
04 24 Physical, physiological and biochemical test equipment and materials
04 25 Cognitive test and evaluation materials
04 26 Assistive products to enhance cognitive function
04 27 Stimulators for treatment on cellular and tissue level
04 28 Assistive products for stimulating senses
04 29 Assistive products for pain relief
04 30 Assistive products for heat treatment or cold treatment
04 33 Assistive products intended to manage tissue integrity
04 45 Assistive products for spinal traction
04 48 Equipment for movement, strength, balance and cardio training
04 49 Wound care products
06 Orthoses and prostheses
06 03 Spinal and cranial orthoses
06 04 Abdominal orthoses
06 06 Upper limb orthoses
06 12 Lower limb orthoses
06 15 Functional neuromuscular stimulators and hybrid orthoses
06 18 Upper limb prostheses
06 24 Lower limb prostheses
06 30 Prostheses other than limb prostheses
09 Assistive products for self-care activities and participation in self-care
09 03 Clothes and shoes
09 06 Body-worn assistive products for body protection
09 07 Assistive products for body stabilization
09 09 Assistive products for dressing and undressing
09 12 Assistive products for toileting
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SIST EN ISO 9999:2022
ISO 9999:2022(E)
09 15 Assistive products for tracheostomy care
09 18 Assistive products for ostomy care
09 21 Products for skin care, skin protection, and skin cleaning
09 24 Urine diverters
09 27 Assistive products for collecting urine and faeces
09 30 Absorbing products to contain urine and faeces
09 31 Assistive products to prevent involuntary urine or faeces leakage
09 32 Assistive products for management of menstruation
09 33 Assistive products for washing, bathing and showering
09 36 Assistive products for nail care
09 39 Assistive products for hair care
09 42 Assistive products for dental care
09 45 Assistive products for facial care
09 54 Assistive products for sexual activity
12 Assistive products for activities and participation relating to personal mobility and transportation
12 02 Assistive products for walking, not manipulated by the arms
12 03 Assistive products for walking, manipulated by one arm
12 06 Assistive products for walking, manipulated by both arms
12 07 Accessories for assistive products for walking
12 08 Guide canes and symbol canes for orientation
12 10 Cars, vans and pick-up trucks
12 11 Mass transit vehicles
12 12 Vehicle accessories and vehicle adaptations
12 16 Mopeds and motorcycles
12 17 Diverse motorized vehicles
12 18 Cycles
12 22 Manual wheelchairs
12 23 Powered wheelchairs
12 24 Wheelchair accessories
12 25 Accessories wheelchair seating
12 27 Diverse human powered vehicles
7
© I
...
SLOVENSKI STANDARD
oSIST prEN ISO 9999:2020
01-september-2020
Tehnični pripomočki - Razvrstitev in terminologija (ISO/DIS 9999:2020)
Assistive products - Classification and terminology (ISO/DIS 9999:2020)
Hilfsmittel - Klassifikation und Terminologie (ISO/DIS 9999:2020)
Produits d’assistance - Classification et terminologie (ISO/DIS 9999:2020)
Ta slovenski standard je istoveten z: prEN ISO 9999
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
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oSIST prEN ISO 9999:2020
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oSIST prEN ISO 9999:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9999
ISO/TC 173/SC 2 Secretariat: JISC
Voting begins on: Voting terminates on:
2020-06-22 2020-09-14
Assistive products — Classification and terminology
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 9999:2020(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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ISO/DIS 9999:2020(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
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ii © ISO 2020 – All rights reserved
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Elements and rules used in classification . 3
4.1 Principle . 3
4.2 Construction . 4
4.3 Codes . 4
4.4 Titles of classes, subclasses and divisions . 5
4.5 Rules used in classification . 5
5 Classification . 6
5.1 One-level classification — Classes . 6
5.2 Two-level classification — Classes and subclasses . 6
5.3 Three-level, detailed classification with explanations, inclusions, exclusions and
references .10
Annex A (informative) Membership of ISO 9999 in the WHO Family of International
Classifications .95
Annex B (informative) Definition of assistive product and the standard title .96
Annex C (informative) Conversion table between ISO 9999:2016 and ISO 9999:2020 .97
Annex D (informative) Alphabetical index .133
Bibliography .191
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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, Subcommittee SC
2, Classification and terminology.
This seventh edition cancels and replaces the sixth edition (ISO 9999:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Change of the titles of the classes to bring them in harmony with the terminology of the ICF.
— Major changes in class 09, class 12 and class 22.
A list of all parts in the ISO 9999 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.
iv © ISO 2020 – All rights reserved
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Introduction
Assistive products (including software) are classified according to their function. The classification
consists of three hierarchical levels and the codes each consist of three pairs of digits. Like other
classifications, for each level, codes, titles, explanatory notes, inclusions, exclusions and cross-references
are given. Besides the explanatory text and the classification itself, a table of conversion between the
previous edition (2016) and this edition and an alphabetical index are provided in order to facilitate the
use of and to improve the accessibility of the classification.
This edition has 948 titles of which about 23 are new and 116 are changed, including minor editorial
and grammatical revisions.
All assistive products in this classification are primarily intended for use outside of health care settings;
however, some of the products can be used in facilities such as rehabilitation centres to teach clients
how to use these products. It should be noted that the titles of some subclasses and divisions in class 28
refer to the “workplace”. This term does not refer to a specific setting or geographical location; instead,
it refers to any setting in which employment-related activities or vocational training are performed.
The definition of “assistive product” used by this International Standard has been revised to align it
with the terminology of the International Classification of Functioning, Disability and Health (ICF).
Relation to the WHO Family of International Classifications
In 2003, ISO 9999 was accepted as a related member of the WHO Family of International Classifications
(WHO-FIC). The WHO-FIC comprises high-quality classifications for relevant sectors of the health
system. With this inclusion, the use of this International Standard was stimulated.
This International Standard makes use of the terminology of the International Classification of
Functioning, Disability and Health (ICF, WHO, 2001). ICF is a classification of health and health-related
domains. These domains are classified from body, individual and societal perspectives by means of two
lists: a list of body functions and structure and a list of domains of activity and participation. Since
an individual's functioning and disability occurs in a context, ICF also includes a list of environmental
factors. Assistive products in this list are viewed as part of the environmental factors. The ICF is one of
the core classifications of the WHO-FIC (see Annex A).
An alphabetical index of terms in Annex D is provided for information to facilitate access to the
classification. Terms used in inclusion statements are incorporated in the index.
Proposal for changes
Proposals for changes or additions to this International Standard, both in respect of existing
and proposed new classes/subclasses/divisions, which take into account the given rules for
classification, may be submitted to a national member body of ISO with an accompanying
explanation for the proposal. See http:// www .iso .org for addresses of national member bodies.
NOTE 1 Some of the assistive products for persons with disability can be classified as medical devices.
NOTE 2 National member bodies are encouraged to improve the accessibility of the classification by the
addition of national language synonyms to the nationally implemented standard.
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oSIST prEN ISO 9999:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 9999:2020(E)
Assistive products — Classification and terminology
1 Scope
This International Standard establishes a classification and terminology of assistive products,
especially produced or generally available, for persons with disability.
Assistive products used by a person with disability, but which require the assistance of another person
for their operation, are included in the classification.
The following items are specifically excluded from this International Standard:
— items used for the installation of assistive products;
— solutions obtained by combinations of assistive products that are individually classified in this
International Standard;
— medicines;
— assistive products and instruments used exclusively by healthcare professionals or by teachers;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.
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 1087-1, Terminology work — Vocabulary — Part 1: Theory and application
1)
ISO 1087-2, Terminology work — Vocabulary — Part 2: Computer applications
ISO 7176-26, Wheelchairs — Part 26: Vocabulary
ISO 8549-1, Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses
and external orthoses
ISO 8549-2, Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses
and wearers of these prostheses
ISO 8549-3, Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to external orthoses
ISO 8669-1, Urine collection bags — Part 1: Vocabulary
ISO 8670-1, Ostomy collection bags — Part 1: Vocabulary
ISO 9949-2, Urine absorbing aids — Vocabulary — Part 2: Products
ISO 9949-3, Urine absorbing aids — Vocabulary — Part 3: Identification of product types
ISO 10535, Hoists for the transfer of disabled persons — Requirements and test methods
1) Withdrawn.
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ISO 11199-1, Walking aids manipulated by both arms — Requirements and test methods — Part 1:
Walking frames
ISO 11199-2, Walking aids manipulated by both arms — Requirements and test methods — Part 2: Rollators
ISO 11334-1, Assistive products for walking manipulated by one arm — Requirements and test methods —
Part 1: Elbow crutches
ISO 11334-4, Walking aids manipulated by one arm — Requirements and test methods — Part 4: Walking
sticks with three or more legs
ISO 22274:2013, Systems to manage terminology, knowledge and content — Concept-related aspects for
developing and internationalizing classification systems
EN 12182, Technical aids for disabled persons — General requirements and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
activity
execution of a task or action by an individual
[SOURCE: ICF 2001, WHO]
3.2
activity limitations
difficulties an individual can have in executing activities
[SOURCE: ICF 2001, WHO]
3.3
assistive product
product which optimizes a person’s functioning and reduces disability
Note 1 to entry: Assistive products include devices, instruments, equipment, and software [ISO 9999:2016].
Note 2 to entry: Assistive products can be especially produced or generally available items [ISO 9999:2016].
3.4
body functions
physiological functions of body systems (including psychological functions)
[SOURCE: ICF 2001, WHO]
3.5
classification
process of assigning objects to classes according to criteria
[SOURCE: ISO 22274:2013]
3.6
class
description of a set of objects that share the same characteristics
[SOURCE: ISO 22274:2013]
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3.7
disability
umbrella term for impairments (3.10), activity limitations (3.2) and participation restrictions (3.13)
denoting the negative aspects of the interaction between an individual (with a health condition) and
that individual’s contextual factors (environmental and personal factors)
[SOURCE: ICF 2001, WHO]
3.8
environmental factors
physical, social and attitudinal environment in which people live and conduct their lives
[SOURCE: ICF 2001, WHO]
3.9
functioning
umbrella term for body functions (3.4), body structures, activities and participation (3.13) denoting the
positive aspects of the interaction between an individual (with a health condition) and that individual’s
contextual factors (environmental and personal factors)
[SOURCE: ICF 2001, WHO]
3.10
impairments
problems in body function or structure, such as a significant deviation or loss
[SOURCE: ICF 2001, WHO]
3.11
person with disability
person with one or more impairments (3.10), one or more activity limitations (3.2), one or more
participation restrictions (3.13) or a combination thereof
3.12
participation
involvement in a life situation
[SOURCE: ICF 2001, WHO]
3.13
participation restrictions
problems an individual can experience in involvement in life situations
[SOURCE: ICF 2001, WHO]
3.14
workplace
any setting in which employment-related activities or vocational training are performed.
4 Elements and rules used in classification
4.1 Principle
The classification is based on the function of the products being classified.
Assistive products that have a principal function other than training, but which can also be used for
training, are included in the class covering their primary function.
Software is classified at the division level of the class according to its function.
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Multifunctional products are also classified based on the primary function. References may be added
related to secondary functions of the item.
4.2 Construction
The classification consists of three hierarchical levels: classes, subclasses and divisions.
Each class, subclass or division consists of a code, a title and, if necessary, an explanatory note and
reference to other parts of the classification.
Explanatory notes are used to clarify the content of the class, subclass or division. Inclusions and
exclusions are used to provide examples.
References are used for two purposes:
— to separate classes, subclasses or divisions from one another;
— for information, e.g. references between related products.
In general, references are made to the lowest possible level.
4.3 Codes
4.3.1 The code consists of three pairs of digits.
The first pair of digits indicates a class, the second pair of digits a subclass and the third pair of digits a
division.
For practical reasons, in this International Standard, the classes are indicated by one pair of digits only
(deleting two pairs of zeros) and subclasses are indicated by two pairs of digits (deleting one pair of zeros).
The code determines the position of the class, the subclass or the division, respectively, in the
classification.
4.3.2 The digits for the codes were originally chosen with intervals of three. In subsequent revisions,
the intervening digits have been used to introduce new classes, subclasses and divisions without
significantly modifying the classification.
Codes that were originally used to classify items that have been removed from the classification are
not used to classify new items that have been added to the classification. As a consequence, the order
of the codes is no longer in all places in intervals of three and the divisions may not in all places follow
a logic order.
4.3.3 Classes 01, 02, and 90 to 99 and the associated subclasses and divisions are reserved for national
applications.
The subclasses XX 01, XX 02, and XX 90 to XX 99 and the associated divisions are reserved for national
applications.
The divisions XX XX 01, XX XX 02 and XX XX 90 to XX XX 99 are reserved for national applications.
Subclasses XX 88 and the divisions XX XX 88 are reserved for assistive products that are titled “Other
(title of parent class or parent subclass)” for international applications.
In addition, further levels, e.g. 4th level, may be added to any part of the classification to serve national
or local purposes
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4.3.4 A conversion table detailing the coding changes from the previous revision of the classification to
this revision is given for information in Annex C.
4.4 Titles of classes, subclasses and divisions
4.4.1 The common language and framework of the ICF is used when appropriate, otherwise
terminology in general use has been adopted; titles of classes are harmonized with the ICF.
4.4.2 All titles in the classification are in the plural form.
4.4.3 Titles at class level generally describe a broad area of function of the product, e.g. assistive
products for domestic activities and participation in domestic life, assistive products for activities and
participation relating to personal mobility and transportation and assistive products for work activities
and participation in employment.
4.4.4 Titles at subclass level describe a special function, e.g. “assistive products for reading”, within
the broad area covered by the class, e.g. “assistive products for communication and information
management”.
4.4.5 Going down to the division level, the description gets more specific.
4.4.6 Only in cases where an assistive product is intended for use by persons with a specific disability,
age or gender should the title refer to that group.
4.5 Rules used in classification
4.5.1 A class is equal to the sum of its subclasses and a subclass is equal to the sum of its divisions.
4.5.2 In general, parts of assistive products, accessories to assistive products, individually adapted
assistive products and individual adaptations in homes and other premises are classified in the same
subclass or division of the assistive product with which they are associated.
4.5.3 Parts, accessories and adaptations are separately classified when they are associated with a
group of assistive products. In these cases, they are classified as close as possible to the group of assistive
products with which they are associated, e.g. 12 07 accessories for assistive products for walking.
4.5.4 The classification is organized in such a manner that all assistive products can be classified
without being tested or measured.
4.5.5 Classification of hypothetical assistive products is avoided.
4.5.6 Classes are created in such a manner that they do not overlap in the described broad function
of other classes. The subclasses are created in such a manner that they do not overlap in the specific
function of other subclasses. The divisions are created in such a manner that they do not overlap with
products in other divisions.
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5 Classification
5.1 One-level classification — Classes
04 Assistive products for measuring, stimulating or training physiological and psychological
body functions
06 Orthoses and prostheses
09 Assistive products for self-care activities and participation in self-care
12 Assistive products for activities and participation relating to personal mobility and trans-
portation
15 Assistive products for domestic activities and participation in domestic life
18 Furnishings, fixtures and other assistive products for supporting activities in indoor and
outdoor human-made environments
22 Assistive products for communication and information management
24 Assistive products for controlling, carrying, moving and handling objects and devices
27 Assistive products for controlling, adapting or measuring elements of physical environments
28 Assistive products for work activities and participation in employment
30 Assistive products for recreation and leisure
5.2 Two-level classification — Classes and subclasses
04 Assistive products for measuring, stimulating or training physiological and psychological
body functions
04 03 Assistive products for respiration
04 06 Assistive products for supporting and stimulating blood circulation
04 08 Assistive products for stimulating body control and conceptualization
04 09 Assistive products for light therapy
04 15 Assistive products for dialysis therapy
04 19 Assistive products for administering medicines
04 22 Sterilizing equipment
04 24 Physical, physiological and biochemical test equipment and materials
04 25 Cognitive test and evaluation materials
04 26 Assistive products to enhance cognitive function
04 27 Stimulators for treatment of muscles tissue and joints
04 28 Assistive products for stimulating senses
04 30 Assistive products for heat treatment or cold treatment
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04 33 Assistive products intended to manage tissue integrity
04 45 Assistive products for spinal traction
04 48 Equipment for movement, strength, balance and cardio training
04 49 Wound care products
06 Orthoses and prostheses
06 03 Spinal and cranial orthoses
06 04 Abdominal orthoses
06 06 Upper limb orthoses
06 12 Lower limb orthoses
06 15 Functional neuromuscular stimulators and hybrid orthoses
06 18 Upper limb prostheses
06 24 Lower limb prostheses
06 30 Prostheses other than limb prostheses
09 Assistive products for self-care activities and participation in self-care
09 03 Clothes and shoes
09 06 Body-worn assistive products for body protection
09 07 Assistive products for body stabilization
09 09 Assistive products for dressing and undressing
09 12 Assistive products for toileting
09 15 Assistive products for tracheostomy care
09 18 Assistive products for ostomy care
09 21 Products for skin protection and skin cleaning
09 24 Urine diverters
09 27 Assistive products for collecting urine and faeces
09 29 Assistive products for pain relief
09 30 Absorbing products to contain urine and faeces
09 31 Assistive products to prevent involuntary urine or faeces leakage
09 32 Assistive products for management of menstruation
09 33 Assistive products for washing, bathing and showering
09 36 Assistive products for manicure and pedicure
09 39 Assistive products for hair care
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09 42 Assistive products for dental care
09 45 Assistive products for facial care
09 54 Assistive products for sexual activity
12 Assistive products for activities and participation relating to personal mobility and trans-
portation
12 02 Assistive products for walking without using hands
12 03 Assistive products for walking, manipulated by one arm
12 06 Assistive products for walking, manipulated by both arms
12 07 Accessories for assistive products for walking
12 08 Guide canes and symbol canes for orientation
12 10 Cars, vans and pick-up trucks
12 11 Mass transit vehicles
12 12 Vehicle accessories and vehicle adaptations
12 16 Mopeds and motorcycles
12 17 Diverse motorized vehicles
12 18 Cycles
12 22 Manual wheelchairs
12 23 Powered wheelchairs
12 24 Wheelchair accessories
12 25 Accessories wheelchair seating
12 27 Diverse human powered vehicles
12 31 Assistive products for changing body position
12 36 Assistive products for lifting persons
15 Assistive products for domestic activities and participation in domestic life
15 03 Assistive products for preparing food and drink
15 06 Assistive products for dishwashing
15 09 Assistive products for eating and drinking
15 12 Assistive products for housecleaning
15 15 Assistive products for making and maintaining textiles for domestic use
15 18 Assistive products for gardening and lawn care for domestic use
18 Furnishings, fixtures and other assistive products for supporting activities in indoor and
outdoor human-made environments
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18 03 Ta
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