prEN ISO 9999

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)

Tehnični pripomočki - Razvrstitev in terminologija (ISO/DIS 9999:2020)

General Information

• Status: Not Published
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.180.01 - Aids for disabled and handicapped persons in general
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 08-Oct-2021
• Completion Date: 08-Oct-2021
• Ref Project: oSIST prEN ISO 9999:2020 - Assistive products - Classification and terminology (ISO/DIS 9999:2020)

RELATIONS

• Revised: EN ISO 9999:2016 - Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
• Effective Date: 26-Oct-2016

Standards Content (sample)

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
oSIST prEN ISO 9999:2020 en,fr,de

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

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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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oSIST prEN ISO 9999:2020
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

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
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Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
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
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
...