ISO 13404-1:2024
(Main)Prosthetics and orthotics — External orthoses and orthotic components — Part 1: Uses, functions, classification and description of lower limb orthoses
Prosthetics and orthotics — External orthoses and orthotic components — Part 1: Uses, functions, classification and description of lower limb orthoses
This document specifies the uses and functions of external lower limb orthoses. It classifies and describes the devices and their components. It permits the systematic classification and description of both the finished orthosis and the components from which it is assembled in a manner that clearly explains their principal characteristics. This document does not specify the materials or manufacturing methods used for the fabrication of lower limb orthoses.
Prothèses et orthèses — Orthèses externes et composants d'orthèses — Partie 1: Utilisations, fonctions, classification et description des orthèses pour les membres inférieurs
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Standards Content (Sample)
International
Standard
ISO 13404-1
First edition
Prosthetics and orthotics —
2024-11
External orthoses and orthotic
components —
Part 1:
Uses, functions, classification and
description of lower limb orthoses
Prothèses et orthèses — Orthèses externes et composants
d'orthèses —
Partie 1: Utilisations, fonctions, classification et description des
orthèses pour les membres inférieurs
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Uses . 3
5 Functions . 4
6 Classification . 5
7 Description . . 5
7.1 Method of fabrication .5
7.2 Type .5
8 Components of orthoses. 5
8.1 General .5
8.2 Structural components .6
8.3 Interface components .6
8.4 Orthotic joints .6
8.4.1 General description . .6
8.4.2 Motions .7
8.4.3 Mode of motion .7
8.4.4 Axis of rotation .7
8.4.5 Control and activation .7
8.5 Functional electrical stimulators.8
8.6 Finishing components .9
Bibliography .10
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
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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
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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 first edition of ISO 13404-1 cancels and replaces ISO 13404:2007, which has been technically revised.
The main changes are as follows:
— introduction of a new Clause 4 on uses;
— update of Clause 5;
— 8.4.5 has been renamed “Control and activation” and its content has been updated to reflect the
development of modern orthotic components;
— addition of functional electrical stimulators to Clause 8.
— a focus on lower limb orthoses.
A list of all parts in the ISO 13404 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
This document is intended for practitioners prescribing and/or providing external lower limb orthoses, for
manufacturers describing their products, and for those researching and reporting on orthotic use.
External lower limb orthoses are used to treat a wide range of impairments of body functions and structures
that impact the lower limb and to assist in overcoming limitations during everyday activities.
Definitions of prefabricated, adaptable, user-matched and custom-made orthoses were changed due to
international regulations. Users can refer to the applicable national regulatory documents for details in
definitions and local differences in terminology and responsibilities.
Uses, functions, classification, method of fabrication, types, and components of the orthotic device should be
described within general healthcare procedures.
For further specifics on foot orthoses, refer to ISO 21064 and for further specifics on soft orthoses for the
lower limb, refer to ISO 21063.
v
International Standard ISO 13404-1:2024(en)
Prosthetics and orthotics — External orthoses and orthotic
components —
Part 1:
Uses, functions, classification and description of lower limb
orthoses
1 Scope
This document specifies the uses and functions of external lower limb orthoses. It classifies and describes
the devices and their components. It permits the systematic classification and description of both the
finished orthosis and the components from which it is assembled in a manner that clearly explains their
principal characteristics.
This document does not specify the materials or manufacturing methods used for the fabrication of lower
limb orthoses.
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 document (including any amendments) applies.
ISO 8549-1, Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and
external orthoses
ISO 8549-3, Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to orthoses
ISO 8551, 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
ISO 21063, Prosthetics and orthotics — Soft orthoses — Uses, functions, classification and description
ISO 21064, Prosthetics and orthotics — Foot orthotics — Uses, functions, classification and description
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8549-1, ISO 8549-3, ISO 8551,
ISO 21063, ISO 21064 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
prefabricated orthosis
mass-produced orthosis
orthosis that is produced by a manufacturer and based on standardized dimensions/designs, normally
available in a range of sizes, and that is not designed for a particular individual
Note 1 to entry: ‘Mass-produced’ is used in regulatory language, ‘prefabricated’ is common in clinical practice.
Note 2 to entry: see also References [6] and [7].
3.2
adaptable orthosis
prefabricated orthosis that is adapted, adjusted, assembled or shaped at the point of care by a healthcare
professional in accordance with the manufacturer’s validated instructions to suit a particular individual
prior to use
[4]
Note 1 to entry: According to EU MDR art. 16(1), a person (e.g. clinical practitioner) who adapts, adjusts, assembles or
shapes an adaptable medical device for a particular user is not regarded as a manufacturer, as long as the adaptation,
adjustment, assembly and shaping does not change the intended purpose or modify the device in such a way that
compliance with the applicable requirements may be affected.
Note 2 to entry: see also References [6] and [7].
3.3
user-matched orthosis
patient-matched orthosis
orthosis matched to an individual’s anatomy within a specified design envelope (intended range of design
variation) using techniques such as scaling based on anatomic references, or by using the full anatomic
features from patient imaging, and designed and produced by a manufacturer typically in a batch through a
process that is capable of being validated and reproduced
Note 1 to entry: The fit of a user-matched orthosis should be controlled by a healthcare professional and can be
adapted at the point of care.
Note 2 to entry: ‘User-matched’ is a synonym for ‘patient-matched’ in References [6] and [7].
3.4
custom-made orthosis
orthosis specifically made by a clinical practitioner in accordance with a prescription provided by an
authorised healthcare professional and intended for the sole use of a particul
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