Basics

Chapter

International Organization for

Standardization (ISO) terminology
David N. Condie

Key Points
 International terminology standards have been
established to facilitate communication and research
regarding orthoses and their uses.
 The method of describing orthoses by reference to the
body segments they encompass is widely accepted
worldwide and now has been complemented by
proposals for the classification and description of
orthotic components.
 A recently approved international standard describing
the methods and the terminology to be used to define
the clinical objectives and functional requirements of
orthoses fosters the development of evidence-based
practice worldwide.

International organization for

standardization
The International Organization for Standardization (ISO) is a
worldwide federation of national standards organizations,
known as ISO member bodies, that has its headquarters
in Geneva, Switzerland. The organization is involved in a
wide range of standardization activities embracing virtually
every aspect of manufacturing, scientific, and commercial
activity.
ISO derives its income from two sources: the fees paid by
member bodies and the sales of documents, primarily standards, that it publishes. Because of this latter funding stream,
all ISO documents are protected by copyright, and no part of
them can be reproduced without the permission of the publisher. This consideration limits the detail of the relevant ISO
standards that can be given in this chapter.

Technical committees and

working Groups
The task of developing ISO standards is performed by
Technical Committees (TCs) and their Working Groups
(WGs). Every member body that expresses an interest in the
work of a TC is entitled to be represented on that TC and its
WGs. The process whereby a new international standard is
developed and eventually published is complex and lengthy.
A proposal must go through a series of stages, first as a New
Work Item Proposal (NWIP), then as a Committee Draft (CD),
then as Draft International Standards (DIS), and finally as
Final Draft International Standards (FDIS), with opportunities
for comment or revision at all stages by the participating
member bodies. The complete process, from the adoption of
a new work item until publication, typically takes a minimum
of 5 years.
The purpose of describing the ISO committee structure
and its method of operation is to make clear that ISO standards development is a closely regulated and controlled process. The resulting standards genuinely reflect the consensual
view of the relevant professional groups.

ISO/TC 168: Prosthetics and Orthotics

ISO/TC 168 was formed in 1979. The Secretariat for the TC
and its WGs has been held throughout its entire existence by
the German national standards organization Deutsches
Institut fur Normung (DIN), which is based in Pforzheim.
The TC operates through three WGs:
 WG 1: Nomenclature and terminology
 WG 2: Medical aspects
 WG 3: Physical testing

Basics
This chapter focuses on the coordinated work of WGs 1
and 2 in the development of ISO standards for terminology in
the field of orthotics.
Before describing the content of the current ISO standards,
it is perhaps appropriate both to pose and to attempt to answer
the question, Why do we need international terminology
standards in orthotics? An answer might be provided by
citing the sentiments expressed in the introductions to some
of the more recently published standards.
In the absence of an internationally accepted method of describing either patients being treated (orthotically) or the orthoses and
their components being employed, the members of the clinic
teams in different countries have tended to develop their own
terminology for this purpose.
This situation creates difficulties for practitioners prescribing
orthoses and for manufacturers describing their products and has
made the reporting of the treatment of particular patient groups
and in particular the comparison of the outcomes of orthotic
treatment in different centres almost impossible.
After ISO 8551 and ISO 13404

-----

ISO 8551
ISO 8549-3
ISO DIS 13404
Fig. 1-2 Original scope model.

Description of the person to be treated with an orthosis,

clinical objectives of treatment, and functional requirements
of the orthosis3
 ISO 13404:2005 Prosthetics and Orthotics
Classification and description of external orthoses and orthotic
components4
The entire currently existing family of ISO orthotic terminology standards is illustrated, as they relate to the original
scope model, in Fig. 1-2.

The standards described in this chapter permit the systematic

and unambiguous description of the patient being treated
with an orthosis, the objectives of the treatment, and both
the functional characteristics and the components from
which the orthoses has been assembled.

ISO 8549-1:1989 Prosthetics and

OrthoticsVocabulary

The standards

This first basic step into the world of ISO standardization

attempts to define the fields of prosthetics and orthotics, the
general terms used to describe prostheses and orthoses, the
anatomy of those parts of the body most commonly fitted
with these devices, and the personnel and procedures
involved in their supply.
The orthotic terms included in this standard are listed in
Box 1-1. An orthosis is defined as an externally applied
device used to modify the structural and functional characteristics of the neuromuscular and skeletal systems. Orthotics
is defined as the science and art involved in treating patients
by the use of an orthosis. An orthotist is defined as a person
who, having completed an approved course of education and
training, is authorised by an appropriate national authority to
design measure and fit orthoses.

One of the first tasks undertaken by WGs 1 and 2 at their

inaugural meeting in St. Andrews, Scotland, in 1980 was an
attempt to define the scope of their future work. This exercise
resulted in the model shown in Fig. 1-1.
The initial work program of the WGs included two standards of relevance to the field of orthotics:
 ISO 8549-1:1989 Prosthetics and OrthoticsVocabulary
General terms for external limb prostheses and external
orthoses1
 ISO 8549-3:1989 Prosthetics and OrthoticsVocabulary
Terms relating to external orthoses2
The majority of the work performed by the WGs in the succeeding 10 years of the TCs existence was directed at the field
of prosthetics; however, the past 5 years has seen the focus of
the WG 1 and 2 program shift in the direction of orthotics, with
the resulting publication of two further important standards:
 ISO 8551:2003 Prosthetics and OrthoticsFunctional
Deficiencies

Personnel
+
procedures
The
patient

The
outcome
The
device

ISO 8549-1

Fig. 1-1 Scope of future work.

General terms for external limb prostheses

and external orthoses

BOX 1-1
General terms, personnel and procedures

Orthosis; orthotic device

Orthotic assessment

Orthotics

Orthotic casting and measurement

Upper limb orthosis

Cast modification

Lower limb orthosis

Tracing modification

Spinal orthosis

Alignment

Orthotist

Bench assembly and alignment

Orthotic technician

Static and dynamic alignment

Finishing and check-out

International Organization for Standardization (ISO) terminology

BOX 1-2
Categories of orthoses

Foot orthosis (FO)

Finger orthosis (FO)

Sacroiliac orthosis (SIO)

Anklefoot orthosis (AFO)

Hand orthosis (HdO)

Lumbosacral orthosis (LSO)

Knee orthosis (KO)

Wristhand orthosis (WHO)

Thoracolumbosacral orthosis (TLSO)

Kneeanklefoot orthosis (KAFO)

Wristhandfinger orthosis (WHFO)

Cervical orthosis (CO)

Hip orthosis (HpO)

Elbow orthosis (EO)

Cervicothoracic orthosis (CTO)

Hipknee orthosis (HKO)

Elbowwristhand orthosis (EWHO)

Cervicothoracolumbosacral orthosis (CTLSO)

Hipkneeanklefoot orthosis (HKAFO)

Shoulder orthosis (SO)

Shoulderelbow orthosis (SEO)
Shoulderelbowwristhand orthosis (SEWHO)

ISO 8549-3:1989 Prosthetics and

OrthoticsVocabulary
Terms relating to external orthoses
This important standard, based on the pioneering work of Dr.
E.E. Harris while working for the Committee for Prosthetic
Research and Development (CPRD) in Washington, DC,
under the direction of A. Bennett Wilson, categorizes orthoses
by reference to the anatomical segments and joints they
encompass and establishes a system of abbreviations derived
from the initial letters of the English terms for each category.
The full range of devices defined in this manner is listed in
Box 1-2. For example, an anklefoot orthosis is defined as
an orthosis which encompasses the ankle joint and the
whole or part of the foot and is referred to by the abbreviation AFO. A wristhandfinger orthosis is defined as an
orthosis that encompasses the wrist joint, the hand, and one
or more fingers and is referred to by the abbreviation
WHFO. A lumbosacral orthosis is defined as an orthosis
that encompasses the whole or part of the lumbar and
sacro-iliac regions of the trunk and is referred to by the
abbreviation LSO.
The degree of acceptance of the system of abbreviations
internationally, even by nonEnglish-speaking orthotic practitioners, has been remarkable.

constructed, which are covered by another standard,

described later.
The first of the three defined objectives of the standardthe description of the person being treatedis
achieved by specifying the method and the terminology
to be used to describe the clinical characteristics listed
in Box 1-3.
It should be emphasized that the clinician using this standard would not routinely record all this information, but
rather would select those items considered relevant to the
particular type of patient and the intended use of the
information.
The second goal of the standard is to establish a consistent
method of defining what are referred to in the standard as
the clinical objectives of the orthotic treatment. Nine basic
objectives (some of which have more than one variant) are
identified in Box 1-4.
For each of these objectives, the information that it recommended to be recorded is specified. For example, if the objective is to relieve pain, the clinician should record which joints
or segments are involved and what induces the pain.
If the objective is to manage a deformity, the information
required includes the joints or segments involved and
whether the deformity is preventable, reducible, or irreducible. Where terms like these, which do not already have a
generally accepted meaning, are used in the standard, definitions are included that make their meaning absolutely clear.

ISO 8551:2003 Prosthetics and

OrthoticsFunctional Deficiencies
Description of the person to be treated with
an orthosis, clinical objectives of treatment,
and functional requirements of the orthosis
This ambitious standard, published in 2003, is intended to
provide clinicians with a method of describing in a consistent
and unambiguous manner the persons they are treating
orthotically, their reasons for doing so, and the conditions
the orthosis must create. It does not include the description
of the complete orthosis or the components from which it is

BOX 1-3
Description of the person to be treated with an orthosis
Personal (e.g., age, height, significant medical history)
Clinical condition to be treated, including diagnosis and
ICD-10 codes
Other clinical conditions present
Motivation and personal needs
Functional abilities

Basics

BOX 1-4
Clinical objectives of orthotic treatment
To relieve pain
To manage deformities
To prevent an excessive range of joint motion
To increase the range of joint motion
To compensate for abnormalities of segment length or shape
To manage abnormal neuromuscular function (e.g., weakness
or hyperactivity)
To protect tissues
To promote healing
To provide other effects (e.g., placebo, warmth, postural
feedback)

The final segment of the standard describes the method

and the terms to be used to describe the functional requirements of the orthosis necessary to achieve the previously
defined clinical objectives. The five categories identified are
listed in Box 1-5.
The reason adoption of this two-stage approach was considered necessary to the development of what is in effect the
orthotic prescription is best illustrated by looking at an example of the use of the standard.
One of the clinical objectives of the orthotic treatment of a
person who suffers from a degenerative joint disease might be
to relieve pain. Depending on the location and severity of the
condition, the functional requirements of the orthosis used to
achieve this objective might be to prevent, reduce, or stabilize
a deformity; to limit the range of a joint; or to reduce or redistribute the load on particular tissues.
A second clinical objective for treatment of this person
might be to manage a deformity. Again depending on the
severity of the condition, the functional requirements for the
orthosis to achieve this objective might be simply to stabilize
the deformity (i.e., prevent it from increasing) or alternatively
to reduce the external loading on the involved joint.
As with the previous section of this standard, for each of
the categories of functional requirement, the information
recommended to be recorded is specified. Thus for the first
clinical objective just discussed, the information regarding
the functional requirements of the orthosis would include
(in addition to defining the joint or segment it is to affect)
(1) the way in which the deformity is to be controlled, that
is, prevented, reduced, or stabilized; (2) the range of joint
motion to be imposed; and (3) the type of loading to be
reduced.

BOX 1-5
Functional requirements of orthoses
To prevent, reduce, or stabilize a deformity
To modify the range of motion of a joint
To add to the length or alter the shape of a segment
To compensate for weak muscle activity or control muscle
hyperactivity
To reduce or redistribute the load on tissues

This standard also contains as an appendix some details of

the different biomechanical effects that orthoses use to
achieve their functional requirements.

ISO 13404:2005 Prosthetics and

Orthotics
Classification and description of orthoses and
orthotic components
This final element of the existing body of ISO orthotic terminology standards is designed to complement ISO 8551 by
providing a means of actually describing the functions and
construction of the orthosis used to achieve a particular set of
clinical objectives and functional requirements.
The first section of the standard describes the method to be
used to classify and describe the complete orthosis. This in
turn comprises three elements. The first element is termed the
general description and recommends the use of the terminology
contained in the previously published ISO 8549-3, that is,
AFO, WHO, SO, and so on, whereas the second element is
termed the function of the orthosis and logically uses the same
terminology as used in ISO 8551 to describe functional requirementsfor example, to prevent, reduce, or stabilize a deformity; to reduce or redistribute the load on tissues; and so on.
The final element of this section simply requires the description of the type of fabrication as being either custom fabricated or prefabricated.
The second section of the standard specifies the method to
be used to classify and describe the components used in the
construction of an orthosis.
Four categories of component are identified:





Interface components
Articulating components
Structural components
Cosmetic components

The standard proceeds to define each category, list the

range of components that belong in each category, and specify
what information is required to describe them. For example,
interface components are defined as those components which
are in direct contact with the user and are responsible for
transmitting the forces which result in its function and may
retain it in place and are considered as including the
following:






Shells
Pads
Straps
Foot orthoses
Shoes (used with an orthosis)

Articulating components, which are defined as components

of orthoses used to allow or control the motion of anatomical
joints, are to be described by specifying the following:
 The anatomical joint whose motions they are intended to
allow or control
 The permissible motions of the joint when assembled in the
finished orthosis
 The form of articulation, either motion between parts
of the joint or deformation of a part of the joint
 The axis of rotation, either monocentric or polycentric

International Organization for Standardization (ISO) terminology

 The type of controls that the joint incorporates (e.g., locks,
limiting mechanisms, assist/resist mechanisms)
Structural components are defined as components which
connect the interface and articulating components and maintain the alignment of the orthosis and include both uprights
and shells.
Finally, cosmetic components are defined as the means of
providing shape, colour and texture to orthoses and include
fillers, covers, and sleeves.

It should be reiterated that the principal reason for institution of the program of orthotic terminology development
described in this chapter was to facilitate communication
among all the parties involved in both the manufacturing
and the clinical aspects of the field of orthotics. Therefore it
is strongly recommended that all those persons who share
this objective should obtain copies of these standards and
endeavor to use the methods and the terms they describe in
an appropriate manner in their day-to-day professional
activity.

Conclusion

References

The publication of ISO 13404 completes the current program

of orthotically linked terminology standards of the ISO/TC
168 WGs. It probably is too soon to assess the degree of acceptance and the impact of the methods and the terms contained
in the two most recently published standards.
Other current work of the WGs that will be of interest to
orthotic practitioners includes an NWIP on which some preliminary work has already taken place to develop a standard
for the description of normal, prosthetic and other pathological gait. Obviously the third element of this proposed standard would be of considerable value when describing
patients functional abilities both before and after orthotic
treatment.

ISO 8549-1:1989 Prosthetics and OrthoticsVocabulary. General terms for external

limb prostheses and external orthoses. Geneva, Switzerland, International
Organization for Standardization.
ISO 8549-3:1989 Prosthetics and OrthoticsVocabulary. Terms relating to external
orthoses. Geneva, Switzerland, International Organization for
Standardization.
ISO 8551:2003 Prosthetics and OrthoticsFunctional deficiencies. Description of the
person to be treated with an orthosis, clinical objectives of treatment, and functional
requirements of the orthosis. Geneva, Switzerland, International Organization
for Standardization.
ISO 13404:2005 Prosthetics and Orthotics. Classification and description of orthoses
and orthotic components. Geneva, Switzerland, International Organization for
Standardization.