International Organization for Standardization (ISO) terminology

Chapter 1 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 für 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

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


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.



The standards


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.


image

Fig. 1-1 Scope of future work.


The initial work program of the WGs included two standards of relevance to the field of orthotics:


• ISO 8549-1:1989 Prosthetics and Orthotics—Vocabulary
General terms for external limb prostheses and external orthoses1

• ISO 8549-3:1989 Prosthetics and Orthotics—Vocabulary
Terms relating to external orthoses2
The majority of the work performed by the WGs in the succeeding 10 years of the TC’s 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 Orthotics—Functional Deficiencies
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.


image

Fig. 1-2 Original scope model.



ISO 8549-1:1989 Prosthetics and Orthotics—Vocabulary



General terms for external limb prostheses and external orthoses


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.”



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
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Orthoses for spinal deformities Orthoses for the muscle disease patient Upper limb orthoses for the person with spinal cord injury Sports adaptations for the physically challenged athlete Orthoses for cerebral palsy Protective equipment to the upper limb in sport

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Jul 12, 2016 | Posted by in ORTHOPEDIC | Comments Off on International Organization for Standardization (ISO) terminology

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