Prosthetics and orthotics - Vocabulary - Part 2: Terms relating to external limb prostheses

This document defines terms used to describe external limb prostheses. The terms related to the amputation level used to in this document are described in ISO 8549‑4. The types of component used in the construction of prostheses are classified and described in ISO 13405‑1, ISO 13405‑2 and ISO 13405‑3. For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics.

Prothèses et orthèses — Vocabulaire — Partie 2: Termes relatifs aux prothèses de membre externes

Le présent document définit les termes employés pour décrire les prothèses de membre externes. Les termes relatifs au niveau d’amputation et utilisés dans ce document sont décrits dans l’ISO 8549-4. Les types de composants utilisés dans la fabrication des prothèses sont classés et décrits dans l’ISO 13405-1, l’ISO 13405-2 et l’ISO 13405-3. Pour les besoins du présent document, le terme abrégé «prothèse» et ses dérivés ne s’appliquent qu’aux prothèses de membre externes.

General Information

Status
Published
Publication Date
18-Oct-2023
Current Stage
6060 - International Standard published
Start Date
19-Oct-2023
Due Date
15-Jun-2024
Completion Date
19-Oct-2023
Ref Project

Relations

Overview

ISO 8549-2:2023 - "Prosthetics and orthotics - Vocabulary - Part 2: Terms relating to external limb prostheses" is an international standard that provides a standardized vocabulary for external limb prostheses. The third edition (2023) updates terminology to cover both upper and lower limb prosthetic systems, clarifies scope (excludes wearers), and aligns with related ISO parts that describe amputation levels and prosthetic components.

Key topics and requirements

  • Scope and purpose: Defines terms used to describe external limb prostheses to ensure consistent communication across clinical, technical and administrative contexts.
  • Terminology: Authoritative definitions for upper- and lower-limb prostheses and related subtypes, including:
    • Upper limb: partial hand, wrist disarticulation, transradial, elbow disarticulation, transhumeral, shoulder disarticulation, scapulothoracic.
    • Lower limb: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral, hip disarticulation, transpelvic.
  • Structure of the document: Scope, terms and definitions, bibliography and index. There are no normative references within this part.
  • Cross-references: Amputation level terms are defined in ISO 8549‑4; component classification and descriptions are addressed in ISO 13405‑1, ‑2 and ‑3.
  • Usage note: The abbreviated term “prosthetics” in this standard is limited to external limb prosthetics.

Applications

ISO 8549-2:2023 is practical for:

  • Prosthetists and orthotists - consistent device description and clinical records.
  • Manufacturers and designers - clear product naming, labeling, and technical documentation.
  • Clinicians and rehabilitation teams - standardized reporting and interprofessional communication.
  • Regulators, payers and procurement - unambiguous specifications for approval, reimbursement and purchasing.
  • Researchers, epidemiologists and public health officials - harmonized terminology for studies, registries and health statistics.
  • Education and training - curriculum development and competency assessment in prosthetics and orthotics.

Related standards

  • ISO 8549-4 - Terms relating to limb amputation (amputation level definitions).
  • ISO 13405-1, ISO 13405-2, ISO 13405-3 - Classification and description of prosthetic components (general, lower limb, upper limb).

Using ISO 8549-2 supports consistent prosthetic terminology, improves interoperability of clinical and regulatory documentation, and reduces ambiguity in device classification and communication across the prosthetics and orthotics community.

Standard
ISO 8549-2:2023 - Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses Released:19. 10. 2023
English language
4 pages
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Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 8549-2
Third edition
2023-10
Prosthetics and orthotics —
Vocabulary —
Part 2:
Terms relating to external limb
prostheses
Prothèses et orthèses — Vocabulaire —
Partie 2: Termes relatifs aux prothèses de membre externes
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Bibliography . 3
Index . 4
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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 168, Prosthetics and orthotics.
This third edition cancels and replaces the second edition (ISO 8549-2:2020), which has been technically
revised.
The main changes are as follows:
— the exclusion of wearers of the prostheses;
— inclusion of upper and lower limb prosthetic systems;
— editorial update.
A list of all parts in the ISO 8549 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
Introduction
T
...

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Frequently Asked Questions

ISO 8549-2:2023 is a standard published by the International Organization for Standardization (ISO). Its full title is "Prosthetics and orthotics - Vocabulary - Part 2: Terms relating to external limb prostheses". This standard covers: This document defines terms used to describe external limb prostheses. The terms related to the amputation level used to in this document are described in ISO 8549‑4. The types of component used in the construction of prostheses are classified and described in ISO 13405‑1, ISO 13405‑2 and ISO 13405‑3. For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics.

This document defines terms used to describe external limb prostheses. The terms related to the amputation level used to in this document are described in ISO 8549‑4. The types of component used in the construction of prostheses are classified and described in ISO 13405‑1, ISO 13405‑2 and ISO 13405‑3. For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics.

ISO 8549-2:2023 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 8549-2:2023 has the following relationships with other standards: It is inter standard links to ISO 8549-2:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

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