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Introducing the nomenclature

Last decennia the international market of components of external prostheses and complete orthoses has been moving towards a real open economy. This development is driven by technological development - that is linked mainly to industrial components and complete products. However the local and national markets are less moving due to the position of local orthopaedic suppliers driven by topical issues, such as customised production and service, national and regional social and reimbursement policy, social and healthcare regulations, multidisciplinary teamwork. In all these influencing factors language, professional preferences, local history and tradition are dominant.

What is behind the international harmonisation of the trade and industry:

  • (European) open market on medical devices.
    Obvious is the role of the European Directive on Medical Devices which is guaranteeing safety to the users of medical devices, product conformity to buyers and open markets for manufacturers and suppliers. A consequence of that is the development of mandatory CEN-standards on products, components and services and European test methods.
    Also have large buyers of equipment to follow procedures with open call for tenders based on EU-procedures;
  • Changing population of users of prostheses and orthoses due to age and health
    The European population is getting older with more persons (absolutely and relatively) having some kind of problem in functioning often due to chronic illness or age. Also is healthy changing into a value which people want to treat and to pay for.
    The group of persons with problems in functioning is smoothly moving towards a consumer driven market. More or less all countries in Europe implement new legislation based on human rights of persons with problems in functioning based on equality, non-exclusion and non-discrimination. Social and healthcare legislation is adapting and stimulating persons to organise their life. Not cure or medical treatment is the standing issue but independence and participation in society are modern goals;
  • Care as facilitator and condition for social independence
    A general accepted principle in developed markets is that clients have rights on continuation of their life without being hindered by the body or the society. Care is seen as a strong tool to support these goals and to keep persons independent and self supporting in their daily life. Persons involved are stimulated to select their own care on the basis of what they need and what they expect will be the proper solution for their life;
  • Changing role of the provider of medical devices
    The traditional providers of medical devices such as local municipalities and healthcare insurance companies/sickness funds are moving into another role: exploiting care for the persons who want it through structures offering care on demand. Issues as the organisation of care as a chain, quality guaranty, budget monitoring and counseling and information services are more important.

The Nomenclature© is a classification-based collection of descriptions of prosthetic and orthotic devices based on its functionality, incorporating international agreed classifications.

Classification based means that all descriptions are connected together with a classification based on the functionality of the described types of prostheses and orthoses. Functionality is defined as what the product does for the user, the so-called intended use of the product.

Main international classifications in the Nomenclature, are:

  • The International Classification of Functioning, Disability and Health (ICF; WHO, 2002); this classification is usable tool to describe the problems in functioning of persons - independent of the underlying course - and to specify what the assistive products including prostheses and orthoses - should contribute;
  • Assistive products for persons with problems in functioning - Classification and terminologie (EN-ISO9999; Geneva/Brussels, 2007);
  • A serious of ISO standards - controlled by ISO TC168/WG1/WG2 - related to (components) prostheses and orthoses and the user of it.

The Nomenclature includes descriptions of types of prostheses and orthoses and its functionality for the user. Components of prostheses and sometimes also orthoses are listed as far as the components have a main intended use to influence the activities of what the person can do with the prostheses or orthosis. For example for lower limb prostheses the functional components and the user interfaces are in the classification independently from the complete prostheses.

As specified only types of prostheses and orthoses are described in the Nomenclature and not all commercial products as put on the market by individual manufacturers with different brand or product names. Brand names are not mentioned and avoided to mention. The descriptions are focussing at a higher level, the level that stands for a identifiable and particular product type seen from the user's perceptive. The descriptions include variants and different commercial versions coming from different companies and commercial sources.

The descriptions include a variety of data, presented in a record structure over a number of fields, including data on the product and its variants, sometimes drawings, the intended user and intended use, classification codes, product related services, etc.

The Nomenclature© is not a static product. The way the product types are described is time-related. Also completion of the Nomenclature is necessary due to new needs from the target group, market changes and technological developments and innovation. That makes that the INTERBOR Nomenclature© is a living tool, which is permanently in development and updated.

The Nomenclature© contains information for all disciplines and target groups active in the field of prostheses and orthoses. Relevant disciplines are medical doctors/physicians, therapists, prosthetists and orthotists as well as other technicians, staff at health care insurance companies and other institutions responsible for the payment of the products, policy makers and national and regional level and of course user groups.

The Nomenclature© can be used for:

  • an information source for appropriate, qualified and up to date information on types of orthopaedic products and related services
  • a knowledge source: a standard for the identification, differentiation and description of product types, based on international agreed classifications
  • an educational tool for professionals as well as user groups
  • an international reference document for the design of new policy
  • an international basis for the creation of national files of products delivered by orthopaedic workshops and orthopaedic industries in relation to systems for the provision of orthoses and prostheses to individuals.
  • This Update 2010 of the INTERBOR Nomenclature© has been finished in October 2010 as un update of the first version published in 2003.
  • This version includes product types in all areas of prostheses and orthoses.
  • The INTERBOR Nomenclature© is accessible through the internet on the basis of a subscription. A try-out if freely accessible on the website of INTERBOR www. Interbor.org.

The Nomenclature© has been developed by a Working Group of experts nominated by the Board of INTERBOR. The members of the Working Group were nominated on personal title by the Board. An external consultant was contracted for the co-ordination of the work.

Experts from ISO TC168/WG1 and WG2 have contributed to the correct use of ISO-standards in the Nomenclature©.

In the framework of the development, the members of the INTERBOR working group contributed to the work:

Co-ordinator and editor

Theo Bougie, The Netherlands, MSc, ME

Members of the working group at 1 January 2010

  • Mrs. Leatitia Chiarelli, Managing Office Director of UFOP Office, Paris, France, MBA, secretary of INTERBOR
  • Mr. Eddy Deschoolmeester, Managing Director EDS-Orthopedie - Kontich, Belgium, CPO, President of INTERBOR,
  • Mr. Luc Thuer, Managing Director of Thuer Orthopedie, Deurne, Belgium, CPO, Treasurer of INTERBOR
  • Mr. Filippo Allegretti, Bologne, Italy, CPO
  • Mrs. Andrea Cerna, NEOPROT company Bratislava, Slovak Republic, CPO
  • Mr. Hendrikus Dijs, University Hospital Antwerpen, Belgium, MD
  • Mr. Jens Franke, BIV Dortmund, Germany, CPO
  • Mr. Rene Gastaldo, Proteor, Dijon, France, CPO
  • Mr. Frank Juttner, President of BIV Germany, Dortmund, Germany, CPO
  • Mr. Dirk van Kuppevelt, ISPO International, Nijmegen, the Netherlands, MD
  • Prof. Jean Paysant, Nancy, France, MD
  • Mr. Michel Pierron, Managing Director of Proteor, Dijon, France
  • Mr. Jurgen Strumpf, Representant of IVO, Fulda, Germany
  • Mr. Robert Wagner, Managing director of NEOPROT, Bratislava, Slovak Republic, APTO
  • Mrs. Jacqueline Walschaerts, Representant of BBOT Bruxelles, Belgium, Bandagist
  • Mr. Angel Garcia Sanchez Reyes, Managing Director of IDEO Ortopedia Mecanica, Sevilla, Spain, CPO.