ISO 8549-1:2020

Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses

This document defines general terms used to describe external limb prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics. NOTE 1 The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3. This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses. NOTE 2 For the purposes of this document, the abbreviated term 'prosthetics' and its derivatives only apply to external limb prosthetics. The abbreviated term 'orthotics' and its derivatives only apply to external orthotics.

Prothèses et orthèses — Vocabulaire — Partie 1: Termes généraux pour prothèses de membre et orthèses externes

General Information

• Status: Published
• Publication Date: 14-Sep-2020
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 168 - Prosthetics and orthotics
• Drafting Committee: ISO/TC 168/WG 1 - Nomenclature and classification
• Current Stage: 9060 - Close of review
• Completion Date: 04-Mar-2031

Relations

• Revises: ISO 8549-1:1989 - Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
• Effective Date: 23-Apr-2020

Overview

ISO 8549-1:2020 is an international standard developed by the International Organization for Standardization (ISO) that establishes a clear and consistent vocabulary related to prosthetics and orthotics, specifically focusing on external limb prostheses and orthoses. This standard serves as the foundational reference for describing devices used to replace or support limbs, as well as the professionals involved in the provision and management of these devices. The document ensures uniform terminology that facilitates communication among healthcare professionals, manufacturers, researchers, and regulatory bodies dealing with limb prosthetics and orthotic devices.

Key Topics

General Terms for External Limb Devices

• Prosthesis (prosthetic device): An externally applied device designed to replace all or part of an absent or deficient limb segment. This includes bone-anchored prosthetic devices.
• Orthosis (orthotic device): An externally applied device that supports or compensates for impairments in the neuro-muscular and skeletal systems.
• Soft Orthosis: Orthoses with soft interface materials applying pressure circumferentially or locally on body parts.

Categories of Devices

• Upper Limb Prosthesis/Orthosis: Devices designed for the upper limb including hand, forearm, and arm segments.
• Lower Limb Prosthesis/Orthosis: Devices for the foot, leg, thigh, and pelvic girdle.
• Spinal Orthosis: Applied to the head and spine for structural support.
• Foot Orthotics: Encompasses orthotic footwear and modifications specific to foot care.

Personnel and Roles

• Prosthetist: Trained professional authorized to assess, design, and fit prosthetic devices.
• Orthotist: Specialist in orthotic device assessment, design, and fitting.
• Prosthetist/Orthotist: Dual-qualified experts working with both prostheses and orthoses.
• Technicians: Prosthetics and orthotics technicians manufacture devices under the supervision of clinicians.
• Foot Orthotist and Hand Therapist: Specialists addressing specific areas of orthotic treatment such as feet and hands.
• Clinic Team: Multidisciplinary group including surgeons, therapists, psychologists, and social workers collaborating in patient care.

Anatomical Terms Defined

• Terms such as upper limb, lower limb, spine, and head are precisely defined to ensure clarity in device application and anatomical referencing.

Applications

ISO 8549-1:2020 is essential for any professionals involved in the clinical, technical, manufacturing, or regulatory aspects of limb prosthetics and orthotics. Its applications include:

• Clinical Practice: Standardized terminology enhances communication among healthcare providers, improving diagnosis, treatment planning, and patient education.
• Device Manufacturing: Manufacturers utilize the vocabulary to design and label prosthetic and orthotic devices accurately, ensuring compliance with international standards.
• Research & Epidemiology: Researchers and health officials benefit from consistent language to gather data, conduct studies, and analyze the impact of prosthetic and orthotic technologies.
• Regulatory Compliance: Regulatory authorities use the standard to evaluate product claims and professional qualifications, supporting public safety and quality assurance.
• Education & Training: Academic institutions and certification bodies apply the standardized terms to develop curricula and qualification criteria for prosthetists and orthotists.

Related Standards

ISO 8549-1:2020 is part of a broader series of standards covering prosthetics and orthotics vocabulary:

• ISO 8549-2: Vocabulary relating to levels of limb amputation and prosthesis wearer terminology.
• ISO 8549-3: Terminology specific to orthoses classification and types.
• ISO 21063: Defines uses, functions, and classification of soft orthoses.
• ISO 21064: Focuses on foot orthotics, including functions and classification.

These related documents complement ISO 8549-1 by elaborating on specific device classifications, anatomical levels, and user groups, ensuring a comprehensive international framework for prosthetic and orthotic terminology.

---

By adopting ISO 8549-1:2020, healthcare providers, manufacturers, and allied professionals worldwide benefit from a harmonized vocabulary that supports the advancement of prosthetic and orthotic sciences, improves patient care quality, and promotes global collaboration in this crucial field.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8549-1
Second edition
2020-09
Prosthetics and orthotics —
Vocabulary —
Part 1:
General terms for external limb
prostheses and external orthoses
Prothèses et orthèses — Vocabulaire —
Partie 1: Termes généraux pour prothèses de membre et orthèses
externes
Reference number
©
ISO 2020
© 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
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Prostheses and orthoses . 1
3.2 Anatomical terms . 2
3.3 Personnel . 3
Annex A (informative) Index of terms . 4
Bibliography . 5
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 168 Prosthetics and orthotics.
This second edition cancels and replaces the first edition (ISO 8549-1:1989), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— definitions of foot orthotics, head orthosis and soft orthosis have been added to the list of areas of
orthotic practise (see 3.1);
— a definition of the head has been added to the list of anatomical terms (see 3.2);
— definitions of foot orthotist, hand therapist and the clinic team have been added to the list of
personnel involved in the prosthetic and orthotic supply process (see 3.3);
— the list definitions of anatomical terms (see 3.2) has been reduced to include only those essential
for the definitions in 3.1 and the list of definitions of the stages of the prosthetic/orthotic supply
process (see 3.3) has been removed as being outdated.
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 © ISO 2020 – All rights reserved

Introduction
Prior to the publication of the first edition of this document in 1989, no internationally accepted
terminology to describe the various areas of prosthetic and orthotic practice, the categories of
prosthetic and orthotic devices and the personnel involved in the supply of these devices existed.
Consequently, the members of the clinic teams in different countries and working in different facilities
had developed their own terminology to meet their own needs.
The terms and definitions provided in this document reflect the changes in the field of prosthetics and
orthotics since the publication of the first edition of this document.
They will allow practitioners to describe, in a standardized manner, the devices they supply and the
personnel involved in the supply process.
This document will also be of value to epidemiologists and national health officials.
Users of this document are also advised of the WHO International
...