ISO 8551:2020
(Main)Prosthetics and orthotics - Functional deficiencies - Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis
Prosthetics and orthotics - Functional deficiencies - Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis
This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.
Prothèses et orthèses — Malformations des membres — Description de la condition de l'utilisateur d'orthèse, objectifs cliniques, et exigences fonctionnelles et biomécaniques de l'orthèse
General Information
- Status
- Published
- Publication Date
- 08-Mar-2020
- 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
- 02-Sep-2030
Relations
- Effective Date
- 23-Apr-2020
Overview
ISO 8551:2020 - Prosthetics and orthotics - Functional deficiencies - provides a standardized method for describing the person to be treated with an orthosis, documenting the clinical objectives of treatment, and specifying the functional requirements of the orthosis. The standard guides clinicians and service providers in recording patient personal factors, health conditions, impairments, activity limitations and use of assistive devices so that orthotic treatment goals and device functions are clearly defined and comparable across settings.
Key topics and requirements
- Patient description: age, gender, height, weight, side dominance, social/physical environment and vocational/recreational activities.
- Health conditions: diagnoses (with relevant ICD codes) and detailed impairments of body structures and functions - alignment, deformity, joint stability, range of motion, muscle strength, neuromuscular control, sensation and pain.
- Other health influences: cardiovascular, respiratory, skin, neurological, endocrine, nutrition, cognition and mental health when relevant.
- Activity limitations: standardized recording for bed mobility, transfers, sitting, standing, walking (graded from unable to walk through independent on uneven surfaces and stairs), and hand/arm use.
- Clinical objectives of treatment: pain relief, activity promotion, deformity management (reducible or fixed), preventing/existing range of motion changes, compensation for segment length/shape abnormalities, managing neuromuscular dysfunction, tissue protection and promotion of healing.
- Functional requirements of the orthosis: mechanical/biomechanical functions needed to meet objectives - prevent/reduce/stabilize deformity, alter joint range of motion, improve segment dimensions (length/shape), influence muscle activity (compensate or control), and redistribute tissue loading.
Applications and who uses it
ISO 8551:2020 is intended for:
- Orthotists, prosthetists and clinicians documenting rehabilitation plans and defining orthotic prescriptions.
- Rehabilitation teams who need a consistent method to set clinical objectives and measure outcomes.
- Manufacturers and designers of orthoses to translate clinical functional requirements into product features.
- Researchers, epidemiologists and health administrators comparing clinical practice patterns, outcomes and service quality across centers and populations.
Using ISO 8551 improves clarity in orthotic treatment planning, supports outcome comparison, and helps ensure orthoses meet documented clinical and functional needs.
Related standards
- ISO 8549‑1, ISO 8549‑3 (vocabulary for prosthetics and orthotics)
- ISO 13404 (categorization and description of orthoses)
- ISO 21063, ISO 21064 (soft and foot orthoses)
- ISO 9999 (assistive products classification), ICD‑10, ICF (functional classification references)
Keywords: ISO 8551:2020, orthosis, prosthetics and orthotics, clinical objectives, functional requirements, orthotic treatment, activity limitations, deformity management.
Frequently Asked Questions
ISO 8551:2020 is a standard published by the International Organization for Standardization (ISO). Its full title is "Prosthetics and orthotics - Functional deficiencies - Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis". This standard covers: This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.
This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.
ISO 8551:2020 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 8551:2020 has the following relationships with other standards: It is inter standard links to ISO 8551:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 8551:2020 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8551
Second edition
2020-03
Prosthetics and orthotics —
Functional deficiencies — Description
of the person to be treated with
an orthosis, clinical objectives
of treatment, and functional
requirements of the orthosis
Prothèses et orthèses — Malformations des membres — Description
de la condition de l'utilisateur d'orthèse, objectifs cliniques, et
exigences fonctionnelles et biomécaniques de l'orthèse
Reference number
©
ISO 2020
© ISO 2020
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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
4 Description of the person to be treated with an orthosis . 2
4.1 General . 2
4.2 Personal factors . 2
4.3 Health conditions to be treated with an orthosis. 2
4.3.1 Disorders or diseases . . 2
4.3.2 Impairments of body structures and functions . 2
4.4 Other health conditions . 2
4.5 Motivation and perceived needs . 3
4.6 Activity limitations . 3
4.6.1 General. 3
4.6.2 Changing and maintaining body position . 3
4.6.3 Walking . 4
4.6.4 Hand and arm use . 4
4.7 Use of assistive devices . 4
5 Clinical objectives of treatment . 4
6 Functional requirements of the orthosis . 5
Bibliography . 7
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
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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
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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 8551:2003), which has been technically
revised. The main changes compared to the previous edition are as follows:
— the terminology used in this document has been revised to make it fully consistent with the
terminology used in Reference [5].
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
The quality of life of a person will depend on the health conditions which affect them, the consequential
impairments to the body functions and structures, and the resulting activity limitations
The aim of orthotic treatment is to manage the impairments, reduce the activity limitations and thus
improve participation in all aspects of daily life.
This document provides clinicians with a method of recording the relevant information regarding the
condition of their patients, the clinical objectives of treatment and the functional requirements of the
orthoses provided to achieve these objectives.
A standard method is essential for comparing the clinical practices and the outcomes of treatment
provided in different centres. Such a method is also of value to epidemiologists and government health
officials.
INTERNATIONAL STANDARD ISO 8551:2020(E)
Prosthetics and orthotics — Functional deficiencies
— Description of the person to be treated with an
orthosis, clinical objectives of treatment, and functional
requirements of the orthosis
1 Scope
This document establishes a method of describing the person to be treated with an orthosis, the clinical
objectives of treatment and the functional requirements of the orthosis.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced do
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