Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)

ISO 9999:2016 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

Status
Withdrawn
Publication Date
08-Nov-2016
Withdrawal Date
31-May-2022
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
01-Jun-2022

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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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SIST EN ISO 9999:2017
EN ISO 9999:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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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.

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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

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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 9999:2017
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

© ISO 2016 – All rights reserved iii
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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.
iv © ISO 2016 – All rights reserved
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ISO 9999:2016(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 (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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ISO 9999:2016(E)
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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ISO 9999:2016(E)
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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ISO 9999:2016(E)

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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ISO 9999:2016(E)

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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ISO 9999:2016(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 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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ISO 9999:2016(E)
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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