SIST EN ISO 9999:2017
(Main)Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
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;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.
Hilfsmittel für Menschen mit Behinderungen - Klassifikation und Terminologie (ISO 9999:2016)
Produits d'assistance pour personnes en situation de handicap - Classification et terminologie (ISO 9999:2016)
ISO 9999:2016 établit une classification ainsi qu'une terminologie des produits d'assistance, fabriqués spécialement ou généralement disponibles, pour les personnes en situation de handicap.
Les produits d'assistance utilisés par une personne en situation de handicap, qui nécessitent l'aide d'une autre personne pour les faire fonctionner, font partie de la classification.
Les articles suivants sont spécifiquement exclus de la présente Norme internationale:
- les articles utilisés pour l'installation des produits d'assistance;
- les solutions obtenues par la combinaison de produits d'assistance individuellement classés dans la présente Norme internationale;
- les médicaments;
- les produits d'assistance et les instruments que seuls les professionnels de la santé utilisent;
- les solutions non techniques, telles que l'assistance personnelle, les chiens d'aveugles ou la lecture labiale;
- les dispositifs implantés;
- l'aide financière.
Tehnični pripomočki za invalidne osebe - Razvrstitev in terminologija (ISO 9999:2016)
Ta mednarodni standard vzpostavlja razvrstitev in terminologijo tehničnih pripomočkov, ki so izdelani posebej za invalidne osebe ali so splošno na voljo.
Razvrstitev vključuje tehnične pripomočke, ki jih uporablja invalidna oseba, vendar je za njihovo delovanje potrebna pomoč še ene osebe.
Ta mednarodni standard izrecno ne vključuje naslednjih elementov:
– elementov, ki se uporabljajo za namestitev tehničnih pripomočkov;
– rešitev, ki nastanejo z združitvijo posameznih tehničnih pripomočkov, ki so razvrščeni v tem mednarodnem standardu;
– zdravil;
– tehničnih pripomočkov in instrumentov, ki jih uporabljajo izključno zdravstveni delavci;
– netehničnih rešitev, kot je osebna pomoč, psi vodniki ali branje z ustnic;
– vsajenih pripomočkov;
– finančne podpore.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9999:2017
01-januar-2017
1DGRPHãþD
SIST EN ISO 9999:2011
7HKQLþQLSULSRPRþNL]DLQYDOLGQHRVHEH5D]YUVWLWHYLQWHUPLQRORJLMD ,62
Assistive products for persons with disability - Classification and terminology (ISO
9999:2016)
Hilfsmittel für Menschen mit Behinderungen - Klassifikation und Terminologie (ISO
9999:2016)
Produits d'assistance pour personnes en situation de handicap - Classification et
terminologie (ISO 9999:2016)
Ta slovenski standard je istoveten z: EN ISO 9999:2016
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.180.01 3ULSRPRþNL]D Aids for disabled and
RQHVSRVREOMHQHLQ handicapped persons in
KHQGLNHSLUDQHRVHEHQD general
VSORãQR
SIST EN ISO 9999:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9999:2017
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SIST EN ISO 9999:2017
EN ISO 9999
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 11.180.01 Supersedes EN ISO 9999:2011
English Version
Assistive products for persons with disability -
Classification and terminology (ISO 9999:2016)
Produits d'assistance pour personnes en situation de Hilfsmittel für Menschen mit Behinderungen -
handicap - Classification et terminologie (ISO Klassifikation und Terminologie (ISO 9999:2016)
9999:2016)
This European Standard was approved by CEN on 29 August 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9999:2016 E
worldwide for CEN national Members.
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EN ISO 9999:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 9999:2017
EN ISO 9999:2016 (E)
European foreword
This document (EN ISO 9999:2016) has been prepared by Technical Committee ISO/TC 173 “Assistive
products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive
products for persons with disability” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 9999:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9999:2016 has been approved by CEN as EN ISO 9999:2016 without any modification.
3
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SIST EN ISO 9999:2017
INTERNATIONAL ISO
STANDARD 9999
Sixth edition
2016-10-15
Assistive products for persons with
disability — Classification and
terminology
Produits d’assistance pour personnes en situation de handicap —
Classification et terminologie
Reference number
ISO 9999:2016(E)
©
ISO 2016
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SIST EN ISO 9999:2017
ISO 9999:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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copyright@iso.org
www.iso.org
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ISO 9999:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Principle . 3
4 Elements and rules used in classification . 3
4.1 Construction . 3
4.2 Codes . 3
4.3 Titles of classes, subclasses and divisions . 4
4.4 Rules used in classification . 4
5 Index . 5
6 Classification . 5
6.1 One-level classification — Classes . 5
6.2 Two-level classification — Classes and subclasses . 5
6.3 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 .107
Annex B (informative) Definition of assistive product and the standard title .108
Annex C (informative) Conversion table between ISO 9999:2011 and ISO 9999:2016 .109
Annex D (informative) Alphabetical index .138
Bibliography .194
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SIST EN ISO 9999:2017
ISO 9999:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 173, Assistive products for persons with disability,
Subcommittee SC 2, Classification and terminology.
This sixth edition cancels and replaces the fifth edition (ISO 9999:2011), which has been technically
revised.
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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 (2011) 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 945 titles of which about 44 are new and 456 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. The ICF is one of the core classifications of the WHO-FIC (see Annex A).
A major change in this edition is a change of the titles of the classes to bring them in harmony with the
terminology of the ICF.
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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SIST EN ISO 9999:2017
INTERNATIONAL STANDARD ISO 9999:2016(E)
Assistive products for persons with disability —
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;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
activity
execution of a task or action by an individual
[SOURCE: ICF 2001, WHO]
2.2
activity limitations
difficulties an individual can have in executing activities
[SOURCE: ICF 2001, WHO]
2.3
assistive product
any product (including devices, equipment, instruments and software), especially produced or generally
available, used by or for persons with disability (2.12)
— for participation (2.13),
— to protect, support, train, measure or substitute for body functions (2.4)/structures and activities, or
— to prevent impairments (2.11), activity limitations (2.2) or participation restrictions (2.14)
Note 1 to entry: The definition of assistive product is in discussion at the GATE, the Global cooperation on
Assistive Health Technology (a WHO initiative), and the information is given in Annex B.
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2.4
body functions
physiological functions of body systems (including psychological functions)
[SOURCE: ICF 2001, WHO]
2.5
body structures
anatomical parts of the body such as organs, limbs and their components
[SOURCE: ICF 2001, WHO]
2.6
classification
system of concepts or a structured set of concepts established according to the relations between them,
each concept being determined by a systematic code and its positions in the system of concepts
2.7
class
collection of similar articles, divided according to definite and chosen rules
2.8
disability
umbrella term for impairments (2.11), activity limitations (2.2) and participation restrictions (2.14)
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]
2.9
environmental factors
physical, social and attitudinal environment in which people live and conduct their lives
[SOURCE: ICF 2001, WHO]
2.10
functioning
umbrella term for body functions (2.4), body structures (2.5), activities and participation (2.13) 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]
2.11
impairments
problems in body function or structure, such as a significant deviation or loss
[SOURCE: ICF 2001, WHO]
2.12
person with disability
person with one or more impairments (2.11), one or more activity limitations (2.2), one or more
participation restrictions (2.14) or a combination thereof
2.13
participation
involvement in a life situation
[SOURCE: ICF 2001, WHO]
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2.14
participation restrictions
problems an individual can experience in involvement in life situations
[SOURCE: ICF 2001, WHO]
2.15
workplace
defined area or areas in which the work activities are carried out
[SOURCE: EN 1540:1998]
3 Principle
The classification is based on the function of the products being classified.
In particular, it should be noted that assistive products, which are used exclusively for training in skills,
are included in class 05. 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 relating 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 Elements and rules used in classification
4.1 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.
4.2 Codes
4.2.1 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.
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4.2.2 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.
In this revision, 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.
4.2.3 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
4.2.4 A conversion table detailing the coding changes from the previous revision of the classification to
this revision is given for information in Annex C.
4.3 Titles of classes, subclasses and divisions
4.3.1 As far as possible, the terminology in general use has been adopted.
4.3.2 All titles in the classification are in the plural form.
4.3.3 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.
4.3.4 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”.
4.3.5 Going down to the division level, the description gets more specific.
4.3.6 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.
4.4 Rules used in classification
4.4.1 A class is equal to the sum of its subclasses and a subclass is equal to the sum of its divisions.
4.4.2 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.
4.4.3 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.
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4.4.4 The classification is organized in such a manner that all assistive products can be classified
without being tested or measured.
4.4.5 Classification of hypothetical assistive products is avoided.
4.4.6 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 Index
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.
6 Classification
6.1 One-level classification — Classes
04 Assistive products for measuring, supporting, training or replacing body functions
05 Assistive products for education and for training in skills
06 Assistive products attached to the body for supporting neuromusculoskeletal or movement
related functions (orthoses) and replacing anatomical structures (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
transportation
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
6.2 Two-level classification — Classes and subclasses
04 Assistive products for measuring, supporting, training or replacing body functions
04 03 Assistive products for respiration
04 06 Assistive products for circulation therapy
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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 for cognitive therapy
04 27 Stimulators
04 30 Assistive products for heat or cold treatment
04 33 Assistive products intended to manage tissue integrity
04 36 Assistive products for perceptual training
04 45 Assistive products for spinal traction
04 48 Equipment for movement, strength and balance training
04 49 Wound care products
05 Assistive products for education and for training in skills
05 03 Assistive products for communication therapy and communication training
05 06 Assistive products for training in alternative and augmentative communication
05 09 Assistive products for continence training
05 12 Assistive products for training in cognitive skills
05 15 Assistive products for training in basic skills
05 18 Assistive products for training in educational subjects
05 24 Assistive products for training in arts
05 27 Assistive products for training in social skills
05 30 Assistive products for training in control of input units and handling products and goods
05 33 Assistive products for training in daily living activities
05 36 Assistive products for training in changing and maintaining body position
06 Assistive products attached to the body for supporting neuromusculoskeletal or
movement related functions (orthoses) and replacing anatomical structures
(prostheses)
06 03 Spinal and cranial orthoses
06 04 Abdominal orthoses
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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 pro
...
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