National foreword

This British Standard is the UK implementation of EN ISO 9999:2022. It is identical to ISO 9999:2022. It supersedes BS EN ISO 9999:2016, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/173, Assistive products for persons with disability.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2022.

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.

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.

This European Standard was approved by CEN on 18 March 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

European foreword

This document (EN ISO 9999:2022) has been prepared by Technical Committee ISO/TC 173 "Assistive products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and accessibility” the secretariat of which is held by SIS.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2022, and conflicting national standards shall be withdrawn at the latest by December 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 9999:2016.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 9999:2022 has been approved by CEN as EN ISO 9999:2022 without any modification.

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

3 Terms and definitions

4 Elements and rules used in classification

4.1 Principle

4.2 Construction

4.3 Codes

4.4 Titles of classes, subclasses and divisions

4.5 Rules used in classification

5 Classification

5.1 One-level classification — Classes

5.2 Two-level classification — Classes and subclasses

5.3 Three-level, detailed classification with explanations, inclusions, exclusions and references

Bibliography

BS EN ISO 9999:2022

Assistive products. Classification and terminology

Current

Published:

30 Jun 2022