ISO 9999:2022
(Main)Assistive products — Classification and terminology
Assistive products — Classification and terminology
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.
Produits d’assistance — Classification et terminologie
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.
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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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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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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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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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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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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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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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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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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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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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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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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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
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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
18 03 Tables
18 06 Light fixtures
18 09 Sitting furniture
18 10 Accessories for sitting furniture
18 12 Beds and bed equipment
18 15 Assistive products for height adjustment of furniture
18 18 Supporting handrails and grab bars
18 21 Gate, door, window and curtain openers/closers
18 24 Construction elements in homes and other premises
18 30 Assistive products for vertical accessibility
18 33 Safety equipment for homes and other premises
18 36 Furniture for storage
22 Assistive products for communication and information management
22 03 Assistive products for seeing
22 06 Assistive products for hearing
22 09 Assistive products for voice and speech functions
22 13 Assistive products for reading, writing and drawing
22 15 Assistive products for calculation and training basic arithmetic
22 18 Assistive products that record, play and display audio and visual information
22 21 Assistive products for face-to-face communication
22 24 Assistive products for distant communication
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ISO 9999:2022(E)
22 28 Assistive products for indication of time, planning, memory, and structuring
22 29 Assistive products for signalling, alarming, monitoring, and identifying
22 31 Assistive products for learning languages
22 33 Computers and terminals
22 39 Output devices
22 45 Assistive products for orientation
24 Assistive products for controlling, carrying, moving and handling objects and devices
24 06 Assistive products for handling containers
24 09 Mechanical assistive products for operation and controlling devices
24 13 Electronic assistive products for operation and controlling devices
24 18 Assistive products to assist or replace arm function, hand function, finger function or combi-
nation of these functions
24 21 Assistive products for extended reach
24 24 Assistive products for positioning
24 27 Assistive products for fixation
24 36 Assistive products for carrying and transporting
27 Assistive products for controlling, adapting or measuring elements of physical environments
27 03 Assistive products for environmental improvement
27 06 Measuring instruments
28 Assistive products for work activities and participation in employment
28 03 Workplace furniture and furnishing elements
28 06 Assistive products for transporting objects in workplaces
28 09 Assistive products for hoisting and repositioning objects in workplaces
28 12 Assistive products for fixing, reaching and grasping objects in workplaces
28 15 Machines and tools for use in workplaces
28 18 Devices for testing and monitoring in workplaces
28 21 Assistive products for office administration, information storage and management at work
28 24 Assistive products for health protection and safety in workplaces
28 27 Assistive products for vocational assessment and vocational training
30 Assistive products for recreation and leisure
30 03 Assistive products for play
30 09 Assistive products for sports
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ISO 9999:2022(E)
30 12 Assistive products for playing and composing music
30 15 Assistive products for producing photos, films and videos
30 18 Handicraft tools, materials and equipment
30 24 Assistive products for hunting and fishing
30 27 Assistive products for camping and caravanning
30 30 Assistive products for smoking
30 34 Assistive products for care of animals
5.3 Three-level, detailed classification with explanations, inclusions, exclusions and
references
Where relevant product standards exist, their terminology is used in this document (see Bibliography).
04 ASSISTIVE PRODUCTS FOR MEASURING, STIMULATING OR TRAINING PHYSIOLOGICAL
AND PSYCHOLOGICAL FUNCTIONS
Products that monitor or assess a person’s medical condition and products for stimulating
or training physiological and psychological functions
Included are, e.g. products used in medical treatment.
Excluded are assistive products used exclusively by healthcare professionals. Devices that
have a function other than training, but that can also be used for training should be included
in the class covering its principal function.
Orthoses and prostheses, see 06
Assistive products for seeing, see 22 03
Assistive products for hearing, see 22 06
Assistive products for vocational assessment and vocational training, see 28 27
04 03 Assistive products for respiration
Equipment for assisting a person to breathe
Respiration meters, see 04 24 3
...
NORME ISO
INTERNATIONALE 9999
Septième édition
2022-05
Produits d’assistance — Classification
et terminologie
Assistive products — Classification and terminology
Numéro de référence
ISO 9999:2022(F)
© ISO 2022
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ISO 9999:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
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ISO 9999:2022(F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives .1
3 Termes et définitions . 1
4 Éléments et règles utilisés dans la classification . 3
4.1 Principe . 3
4.2 Construction . 3
4.3 Codes . 4
4.4 Titres des classes, des sous-classes et des divisions . 4
4.5 Règles utilisées dans la classification . 5
5 Classification . 5
5.1 Classification à un niveau — Classes . 5
5.2 Classification à deux niveaux — Classes et sous-classes . 6
5.3 Classification détaillée à trois niveaux avec explications, éléments inclus, éléments
exclus et références . 10
Annexe A (informative) ISO 9999 membre de la Famille OMS des classifications
internationales . 108
Annexe B (informative) Précisions concernant la définition de «produit d’assistance» . 109
e
Annexe C (informative) Tableau de conversion entre l’ISO 9999:2016 (6 édition) et le
e
présent document (ISO 9999:2022, 7 édition) .110
Annexe D (informative) Index alphabétique . 148
Bibliographie . 202
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ISO 9999:2022(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. Le ISO ne saurait être tenu pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir le lien suivant: www.iso.org/iso/fr/avant-propos.
Le présent document a été élaboré par le comité ISO/TC 173, Produits d’assistance, sous-comité SC 2,
Classification et terminologie, en collaboration avec le comité technique CEN/TC 293, Aides techniques
pour personnes handicapées, du comité européen de normalisation (CEN), conformément à l’Accord de
coopération technique entre l’ISO et le CEN (Accord de Vienne).
Cette septième édition annule et remplace la sixième édition (ISO 9999:2016), qui a fait l’objet d’une
révision technique. Les principales modifications apportées sont les suivantes:
— suppression de la classe 05;
— changements majeurs dans la classe 09, la classe 12 et la classe 22.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/fr/members.html.
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ISO 9999:2022(F)
Introduction
Les produits d’assistance (y compris les logiciels) sont classés selon leur fonction. La classification
consiste en trois niveaux hiérarchiques et chaque code consiste en trois paires de chiffres. Comme pour
d’autres classifications, et pour les codes à chaque niveau, des notes explicatives, des éléments inclus,
des éléments exclus et des références sont donnés. Mis à part le texte explicatif et la classification
proprement dite, un tableau de conversion entre l’édition précédente (ISO 9999:2016) et le présent
document (ISO 9999:2022) ainsi qu’un index alphabétique sont fournis afin de faciliter l’utilisation de la
classification et de la rendre plus accessible.
Le présent document comporte 948 titres dont environ 23 sont nouveaux et 116 ont été modifiés,
y compris par des révisions rédactionnelles mineures.
L’ensemble des produits d’assistance dans cette classification est principalement destiné à être utilisé
en dehors des établissements de santé; toutefois, certains produits peuvent être utilisés dans des
installations telles que des centres de rééducation pour apprendre aux usagers comment utiliser ces
produits. Il convient de noter que les titres de certaines sous-classes et divisions de la classe 28 font
référence au «lieu de travail». Ce terme ne fait pas référence à un cadre spécifique ou à un emplacement
géographique donné; il fait référence à tout cadre dans lequel des activités professionnelles ou de
formation professionnelle se déroulent.
La définition de «produit d’assistance» utilisée par le présent document a été révisée afin de
l’harmoniser avec la terminologie de la Classification internationale du fonctionnement, du handicap et
de la santé (CIF, OMS, 2018).
En 2003, l’ISO 9999 a été reconnue comme étant apparentée à la famille OMS des classifications
internationales (FCI-OMS). La FCI-OMS regroupe des classifications de haute qualité propres aux
secteurs appropriés du système de santé. Grâce à cette inclusion, l’utilisation du présent document a été
renforcée.
Le présent document utilise la terminologie de la CIF qui est une classification des domaines relatifs
à la santé et domaines connexes. Ces domaines sont classés d’un point de vue organique, individuel
et social au moyen de deux listes: une liste de fonctions organiques et de structures anatomiques, et
une liste de domaines d’activité et de participation. Étant donné que le fonctionnement et l’incapacité
d’un individu sont associés à un contexte, la CIF inclut également une liste de facteurs d’environnement.
Les produits d’assistance figurant dans cette liste sont considérés comme faisant partie des facteurs
d’environnement. La CIF est l’une des classifications essentielles de l’OMS/FCI (voir Annexe A).
Un index alphabétique est inclus pour information à l’Annexe D afin de simplifier l’accès à la classification.
L’index inclut des termes utilisés dans les mentions incluses.
NOTE Une partie des produits d’assistance peut être classée comme dispositifs médicaux.
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NORME INTERNATIONALE ISO 9999:2022(F)
Produits d’assistance — Classification et terminologie
1 Domaine d’application
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.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/ .
3.1
activité
réalisation d’une tâche ou d’une action par une personne
[SOURCE: CIF 2018, OMS]
3.2
limitation d’activité
difficultés qu’une personne peut rencontrer dans l’exécution d’activités (3.1)
[SOURCE: CIF 2018, OMS]
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ISO 9999:2022(F)
3.3
produit d’assistance
produit qui optimise le fonctionnement d’une personne et réduit son incapacité
Note 1 à l'article: Voir Annexe B.
Note 2 à l'article: Les produits d’assistance incluent des dispositifs, des instruments, des équipements et des
logiciels.
Note 3 à l'article: Les produits d’assistance peuvent être des articles fabriqués spécialement ou existants sur le
marché.
3.4
fonction organique
fonctions physiologiques des organes (y compris les fonctions psychologiques)
[SOURCE: CIF 2018, OMS]
3.5
structure anatomique
parties structurelles du corps comme les organes, les membres et leurs composants
[SOURCE: CIF 2018, OMS]
3.6
incapacité
terme générique désignant les déficiences (3.9), les limitations d’activité (3.2) et les restrictions de la
participation (3.12), dénotant l’aspect négatif de l’interaction entre une personne (ayant un problème de
santé) et les facteurs contextuels de cette personne (facteurs d’environnement et facteurs personnels)
[SOURCE: CIF 2018, OMS]
3.7
facteur d’environnement
environnement physique, social et psychologique dans lequel les personnes vivent et mènent leur vie
[SOURCE: CIF 2018, OMS]
3.8
fonctionnement
terme générique désignant les fonctions organiques (3.4), les structures anatomiques, les activités
(3.1) et la participation (3.11), dénotant l’aspect positif de l’interaction entre une personne (ayant un
problème de santé) et les facteurs contextuels de cette personne (facteurs d’environnement et facteurs
personnels)
[SOURCE: CIF 2018, OMS]
3.9
déficience
problèmes relatifs aux fonctions organiques ou à la structure anatomique, tels qu’un écart important ou
une perte de l’usage
[SOURCE: CIF 2018, OMS]
3.10
personne en situation de handicap
personne qui a une ou plusieurs déficiences (3.9), une ou plusieurs limitations d’activité (3.2), une ou
plusieurs restrictions de la participation (3.12), ou une combinaison de déficiences, de limitations
d’activité et/ou de restrictions de la participation
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ISO 9999:2022(F)
3.11
participation
implication dans une situation de la vie réelle
[SOURCE: CIF 2018, OMS]
3.12
restriction de la participation
problèmes qu’une personne peut rencontrer pour s’impliquer dans une situation de la vie réelle
[SOURCE: CIF 2018, OMS]
3.13
lieu de travail
cadre dans lequel des activités professionnelles ou de formation professionnelle se déroulent
3.14
robot
mécanisme actionné via un programme présentant un certain degré d’autonomie pour réaliser une
locomotion, une manipulation ou un positionnement
Note 1 à l'article: Un robot englobe le système de commande et l’interface du système de commande.
4 Éléments et règles utilisés dans la classification
4.1 Principe
La classification repose sur la fonction des produits faisant l’objet du classement.
Les produits d’assistance ayant une fonction principale autre que l’entraînement mais qui peuvent aussi
être utilisés pour l’entraînement sont inclus dans la classe couvrant leur fonction principale.
Les logiciels sont classés selon leur fonction.
Les produits multifonction sont également classés suivant la fonction principale. Des références
concernant les fonctions secondaires de l’article peuvent être ajoutées.
4.2 Construction
La classification se décompose en trois niveaux hiérarchiques, appelés respectivement classes, sous-
classes et divisions.
Chaque classe, sous-classe ou division se compose d’un code, d’un titre et, si nécessaire, d’une note
explicative et d’une référence à d’autres parties de la classification.
Les notes explicatives sont utilisées pour clarifier le contenu de la classe, de la sous-classe ou de la
division. Les éléments inclus et les éléments exclus servent à fournir des exemples.
Les références ont deux fonctions:
— distinguer les classes, les sous-classes ou les divisions;
— fonction informative, par exemple les références entre produits apparentés.
Les références sont généralement faites au niveau le plus bas possible.
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ISO 9999:2022(F)
4.3 Codes
4.3.1 Le code se compose de trois paires de chiffres.
La première paire de chiffres indique une classe, la deuxième paire indique une sous-classe et la
troisième paire une division.
Pour des raisons pratiques, dans le présent document, les classes sont indiquées par une paire de
chiffres seulement (en supprimant deux paires de zéros) et les sous-classes par deux paires de chiffres
(en supprimant une paire de zéros).
Le code détermine respectivement la position de la classe, de la sous-classe ou de la division dans la
classification.
4.3.2 Les chiffres des codes ont été choisis au départ par tranches de trois. Dans les révisions
ultérieures, les chiffres intermédiaires ont été utilisés pour introduire de nouvelles classes, sous-
classes et divisions sans changer complètement la classification.
Les codes utilisés au départ pour classer des articles aujourd’hui retirés de la classification ne sont pas
utilisés pour classer de nouveaux articles ajoutés à la classification. En conséquence, l’ordre des codes
n’est plus partout par intervalles de trois et les divisions peuvent ne pas suivre partout un ordre logique.
4.3.3 Les classes 01, 02, de 90 à 99, ainsi que les sous-classes et divisions correspondantes, sont
réservées à des applications d’ordre national.
Les sous-classes XX 01, XX 02, de XX 90 à XX 99, ainsi que les divisions correspondantes, sont réservées
à des applications d’ordre national.
Les divisions XX XX 01, XX XX 02 et de XX XX 90 à XX XX 99 sont réservées à des applications d’ordre
national.
Les sous-classes XX 88 et les divisions XX XX 88 sont réservées aux produits d’assistance intitulés
«Autre (titre de classe parente ou de sous-classe parente)» pour des applications d’ordre international.
e
Par ailleurs, des niveaux supplémentaires, comme un 4 niveau, peuvent être ajoutés à toute partie de la
classification pour répondre à des besoins d’ordre national ou local.
4.3.4 Un tableau de conversion détaillant les différences de codification entre la précédente
édition (ISO 9999:2016) de la classification et le présent document est donné à l’Annexe C.
4.4 Titres des classes, des sous-classes et des divisions
4.4.1 Le langage et le cadre communs de la CIF sont utilisés lorsque cela est approprié, sinon la
terminologie adoptée est celle correspondant à l’usage courant; les titres des classes sont harmonisés
avec la CIF.
4.4.2 Tous les titres adoptés dans la classification sont au pluriel.
4.4.3 Les titres au niveau de la classe décrivent généralement un domaine étendu de fonction
du produit, par exemple produits d’assistance aux activités domestiques et à la participation à la
vie domestique, produits d’assistance aux activités et à la participation en rapport avec la mobilité
personnelle et le transport et produits d’assistance aux activités professionnelles et à la participation à
l’emploi.
4.4.4 Les titres du niveau de la sous-classe décrivent une fonction particulière, par exemple
«produits d’assistance à la lecture», dans le domaine étendu couvert par la classe, par exemple «produits
d’assistance à la gestion de la communication et de l’information».
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ISO 9999:2022(F)
4.4.5 En descendant jusqu’au niveau de la division, la description devient plus spécifique.
4.4.6 Si un produit d’assistance est destiné à être utilisé par des personnes atteintes d’une incapacité
spécifique ou par des personnes d’âge ou de sexe particulier, et seulement dans ce cas, il convient que le
titre se réfère à ce groupe de personnes.
4.5 Règles utilisées dans la classification
4.5.1 Une classe est égale à la somme de ses sous-classes et une sous-classe à la somme de ses
divisions.
4.5.2 Les pièces détachées et accessoires de produits d’assistance, les produits d’assistance
personnalisés et les adaptations individuelles dans les logements et autres lieux font généralement
partie des produits d’assistance auxquels ils sont associés.
4.5.3 Les pièces détachées, les accessoires et les adaptations sont classés séparément quand ils
correspondent à un groupe de produits d’assistance. Ils sont alors classés aussi près que possible du
groupe de produits d’assistance auquel ils sont associés, par exemple 12 07 accessoires pour produits
d’assistance à la marche.
4.5.4 La classification est organisée de telle sorte que tous les produits d’assistance puissent être
classés sans être soumis à des essais ou mesurés.
4.5.5 Une classification des produits d’assistance hypothétiques a été évitée.
4.5.6 Les classes sont créées de telle sorte qu’elles n’empiètent pas sur la description de la fonction
étendue d’autres classes. Les sous-classes sont créées de telle sorte qu’elles n’empiètent pas sur la
fonction spécifique d’autres sous-classes. Les divisions sont créées de telle sorte qu’elles n’empiètent
pas sur les produits d’autres divisions.
5 Classification
5.1 Classification à un niveau — Classes
04 Produits d’assistance pour mesurer, stimuler ou entraîner les fonctions physiologiques et
psychologiques
06 Orthèses et prothèses
09 Produits d’assistance aux activités d’entretien personnel et à la participation à l’entretien
personnel
12 Produits d’assistance aux activités et à la participation en rapport avec la mobilité personnelle
et le transport
15 Produits d’assistance aux activités domestiques et à la participation à la vie domestique
18 Aménagements, accessoires et autres produits d’assistance aux activités de soutien dans les
environnements intérieurs et extérieurs créés par l’homme
22 Produits d’assistance à la gestion de la communication et de l’information
24 Produits d’assistance pour contrôler, porter, déplacer et manipuler des objets et des dispositifs
5
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ISO 9999:2022(F)
27 Produits d’assistance pour contrôler, adapter ou mesurer les éléments des environnements
physiques
28 Produits d’assistance aux activités professionnelles et à la participation à l’emploi
30 Produits d’assistance à la récréation et aux loisirs
5.2 Classification à deux niveaux — Classes et sous-classes
04 Produits d’assistance pour mesurer, stimuler ou entraîner les fonctions physiologiques et
psychologiques
04 03 Produits d’assistance à la respiration
04 06 Produits d’assistance pour soutenir et stimuler la circulation sanguine
04 08 Produits d’assistance à la stimulation du contrôle et de la conceptualisation du corps
04 09 Produits d’assistance pour la photothérapie
04 15 Produits d’assistance à la dialyse
04 19 Produits d’assistance à l’administration des médicaments
04 22 Équipement de stérilisation
04 24 Équipement et matériel de contrôle physique, physiologique et biochimique
04 25 Matériels de contrôle et d’évaluation de la cognition
04 26 Produits d’assistance pour améliorer la fonction cognitive
04 27 Stimulateurs pour le traitement au niveau cellulaire et tissulaire
04 28 Produits d’assistance à la stimulation des sens
04 29 Produits d’assistance au soulagement de la douleur
04 30 Produits d’assistance à la thermothérapie ou à la cryothérapie
04 33 Produits d’assistance destinés à préserver l’intégrité des tissus
04 45 Produits d’assistance pour l’élongation vertébrale
04 48 Équipements pour l’entraînement du mouvement, de la force, de l’équilibre et l’entraînement
cardio-vasculaire
04 49 Produits de soin des plaies
06 Orthèses et prothèses
06 03 Orthèses crâniennes et rachidiennes
06 04 Orthèses abdominales
06 06 Orthèses du membre supérieur
06 12 Orthèses du membre inférieur
06 15 Stimulateurs fonctionnels neuromusculaires et orthèses hybrides
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ISO 9999:2022(F)
06 18 Prothèses du membre supérieur
06 24 Prothèses du membre inférieur
06 30 Prothèses autres que celles des membres
09 Produits d’assistance aux activités d’entretien personnel et à la participation à l’entretien
personnel
09 03 Vêtements et chaussures
09 06 Produits d’assistance à la protection du corps portés sur le corps
09 07 Produits d’assistance à la stabilisation du corps
09 09 Produits d’assistance à l’habillage et au déshabillage
09 12 Produits d’assistance à l’hygiène
09 15 Produits d’assistance aux trachéotomisés
09 18 Produits d’assistance à la stomie
09 21 Produits pour le soin, la protection et le nettoyage de la peau
09 24 Systèmes d’évacuation de l’urine
09 27 Produits d’assistance au recueil des urines et des matières fécales
09 30 Produits absorbants pour contenir l’urine et les matières fécales
09 31 Produits d’assistance évitant les fuites involontaires d’urine ou de matières fécales
09 32 Produits d’assistance à la gestion des menstruations
09 33 Produits d’assistance permettant de se laver, de se baigner et de se doucher
09 36 Produits d’assistance aux soins des ongles
09 39 Produits d’assistance aux soins des cheveux
09 42 Produits d’assistance aux soins dentaires
09 45 Produits d’assistance aux soins du visage
09 54 Produits d’assistance à l’activité sexuelle
12 Produits d’assistance aux activités et à la participation en rapport avec la mobilité personnelle
et le transport
12 02 Produits d’assistance à la marche non manipulés par les bras
12 03 Produits d’assistance à la marche manipulés par un bras
12 06 Produits d’assistance à la marche manipulés par les deux bras
12 07 Accessoires pour produits d’assistance à la marche
12 08 Cannes de déplacement et cannes de signalement pour l’orientation
12 10 Voitures, fourgonnettes et pick-ups
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ISO 9999:2022(F)
12 11 Véhicules de transport collectif
12 12 Accessoires et adaptations de véhicules
12 16 Cyclomoteurs et motocycles
12 17 Autres véhicules motorisés
12 18 Cycles
12 22 Fauteuils roulants manuels
12 23 Fauteuils roulants motorisés
12 24 Accessoires de fauteuils roulants
12 25 Accessoires pour systèmes de soutien du corps de fauteuils roulants
12 27 Autres véhicules à propulsion humaine
12 31 Produits d’assistance permettant de changer la position du corps
12 36 Produits d’assistance permettant de lever des personnes
15 Produits d’assistance aux activités domestiques et à la participation à la vie domestique
15 03 Produits d’assistance à la préparation de la nourriture et des boissons
15 06 Produits d’assistance pour laver la vaisselle
15 09 Produits d’assistance pour manger et boire
15 12 Produits d’assistance pour nettoyer la maison
15 15 Produits d’assistance à la confection et à l’entretien du linge pour un usage domestique
15 18 Produits d’assistance au jardinage et à l’entretien des pelouses pour un usage domestique
18 Aménagements, accessoires et autres produits d’assistance aux activités de soutien dans les
environnements intérieurs et extérieurs créés par l’homme
18 03 Tables
18 06 Équipements d’éclairage
18 09 Mobilier d’assise
18 10 Accessoires de mobilier d’assise
18 12 Lits et équipements de lit
18 15 Produits d’assistance pour régler la hauteur du mobilier
18 18 Rampes et barres d’appui
18 21 Dispositifs d’ouverture et de fermeture de portails, de portes, de fenêtres et de rideaux
18 24 Éléments de construction dans les logements et dans d’autres locaux
18 30 Produits d’assistance pour l’accessibilité verticale
18 33 Équipements de sécurité pour les logements et autres locaux
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ISO 9999:2022(F)
18 36 Meubles de rangement
22 Produits d’assistance à la gestion de la communication et de l’information
22 03 Produits d’assistance à la vision
22 06 Produits d’assistance à l’ouïe
22 09 Produits d’assistance aux fonctions de la voix et de la parole
22 13 Produits d’assistance pour lire, écrire et dessiner
22 15 Produits d’assistance au calcul et à la formation aux opérations arithmétiques de base
22 18 Produits d’assistance permettant l’enregistrement, la lecture et l’affichage d’informations
sonores et visuelles
22 21 Produits d’assistance à la co
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9999
ISO/TC 173/SC 2
Assistive products — Classification
Secretariat: JISC
and terminology
Voting begins on:
2021-12-14
Produits d’assistance — Classification et terminologie
Voting terminates on:
2022-02-08
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 9999:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 9999:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
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ISO/FDIS 9999:2021(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:--, 7th edition) . 104
Annex D (informative) Alphabetical index . 138
Bibliography . 194
iii
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ISO/FDIS 9999:2021(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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ISO/FDIS 9999:2021(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:—) 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, 2020).
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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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 9999:2021(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 2020, WHO]
3.2
activity limitation
difficulties an individual can have in executing activities (3.1)
[SOURCE: ICF 2020, WHO]
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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 2020, WHO]
3.5
body structure
anatomical parts of the body such as organs, limbs and their components
[SOURCE: ICF 2020, 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 2020, WHO]
3.7
environmental factor
physical, social and attitudinal environment in which people live and conduct their lives
[SOURCE: ICF 2020, WHO]
3.8
functioning
umbrella term for body functions (3.4), body structures, activities 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 2020, WHO]
3.9
impairment
problems in body function or structure, such as a significant deviation or loss
[SOURCE: ICF 2020, 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 2020, WHO]
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3.12
participation restriction
problems an individual can experience in involvement in life situations
[SOURCE: ICF 2020, 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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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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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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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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ISO/FDIS 9999:2021(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
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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
18 03 Tables
18 06 Light fixtures
18 09 Sitting furniture
18 10 Accessories for sitting furniture
18 12 Beds and bed equipment
18 15 Assistive products for height adjustment of furniture
18 18 Supporting handrails and grab bars
18 21 Gate, door, window and curtain openers/closers
18 24 Construction elements in homes and other premises
18 30 Assistive products for vertical accessibility
18 33 Safety equipment for homes and other premises
18 36 Furniture for storage
22 Assistive products for communication and information management
22 03 Assistive products for seeing
22 06 Assistive products for hearing
22 09 Assistive products for voice and speech functions
22 13 Assistive products for reading, writing and drawing
22 15 Assistive products for calculation and training basic arithmetic
22 18 Assistive products that record, play and display audio and visual information
22 21 Assistive products for face-to-face communication
22 24 Assistive products for distant communication
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22 28 Assistive products for indication of time, planning, memory, and structuring
22 29 Assistive products for signalling, alarming, monitoring, and identifying
22 31 Assistive products for learning languages
22 33 Computers and terminals
22 39 Output devices
22 45 Assistive products for orientation
24 Assistive products for controlling, carrying, moving and handling objects and devices
24 06 Assistive products for handling containers
24 09 Mechanical assistive products for operation and controlling devices
24 13 Electronic assistive products for operation and controlling devices
24 18 Assistive products to assist or replace arm function, hand function, finger function or combi-
nation of these functions
24 21 Assistive products for extended reach
24 24 Assistive products for positioning
24 27 Assistive products for fixation
24 36 Assistive products for carrying and transporting
27 Assistive products for controlling, adapting or measuring elements of physical environments
27 03 Assistive products for environmental improvement
27 06 Measuring instruments
28 Assistive products for work activities and participation in employment
28 03 Workplace furniture and furnishing elements
28 06 Assistive products for transporting objects in workplaces
28 09 Assistive products for hoisting and repositioning objects in workplaces
28 12 Assistive products for fixing, reaching and grasping objects in workplaces
28 15 Machines and tools for use in workplaces
28 18 Devices for testing and monitoring in workplaces
28 21 Assistive products for office administration, information storage and management at work
28 24 Assistive products for health protection and safety in workplaces
28 27 Assistive products for vocational assessment and vocational training
30 Assistive products for recreation and leisure
30 03 Assistive products for play
30 09 Assistive products for sports
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30 12 Assistive products for playing and composing music
30 15 Assistive products for producing photos, films and videos
30 18 Handicraft tools, materials and equipment
30 24 Assistive products for hunting and fishing
30 27 Assistive products for camping and caravanning
30 30 Assistive products for smoking
30 34 Assistive products for care of animals
5.3 Three-level, detailed classification with explanations, inclusions, exclusions and
references
Where relevant product standards exist, their terminology is used in this document (see Bibliography).
04 ASSISTIVE PRODUCTS FOR MEASURING, STIMULATING OR TRAINING PHYSIOLOGICAL
AND PSYCHOLOGICAL FUNCTIONS
Products that monitor or assess a person’s medical condit
...
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