Assistive products for persons with disability - Classification and terminology (ISO 9999:2011)
Basic Bibliographic Information
Status:
Operational
Type:
To Be Determined
Citation:
ICS: 11.180.01
ISBN:
N/A
Website:
Custodian:
International Organization for Standardization
Available Formats:
N/A
Year Adopted:
N/A
Year Published:
2011
Available Languages (besides English):
Français, Español, 中文, Danish, Dutch, Finnish, German, Japanese, Korean, Portuguese, Swedish
Details... Français
Produits d'assistance pour personnes en situation de handicap - Classification et terminologie (ISO 9999:2011)
Español
Productos de apoyo para personas con discapacidad. Clasificación y terminología (ISO 9999:2011)
Danish
Hjælpemidler til personer med funktionsnedsættelse – Klassifikation og terminologi (ISO 9999:2011)
Dutch
Hulpmiddelen voor mensen met functioneringsproblemen - Classificatie en terminologie (ISO 9999:2011)
Finnish
Vammaisten apuvälineet. Luokitus ja termit (ISO 9999:2011)
German
Hilfsmittel für Menschen mit Behinderungen - Klassifikation und Terminologie (ISO 9999:2011)
Portuguese
Produtos Assistivos para Pessoas com Deficiencia - Classificacao e Terminologia (ISO 9999:2011)
Swedish
Hjälpmedel för personer med funktionsnedsättning - Klassificering och terminologi (ISO 9999:2011)
Availability:
Fully available in all of the languages above
Purpose of the Classification
Statistical Domains:
1.4 Health
Purpose:
Establishment of a classification of assistive products, especially produced or generally available, for persons with disability
Main Applications:
Databases of assistive products, e.g. to inform the public about possible solutions for their functioning problems. Reimbursement. In some countries it concerns with social security system for persons with disability.
Main Users:
healthcare professionals, persons with disability, caregivers, government officers in social security, health insurances, manufacturers, etc.
Methodology
Scope:
Assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included. The following items are specifically excluded: items used for the installation of assistive products; solutions obtained by combinations of assistive products that are individually classified in this International Standard; medicines; assistive products and instruments used exclusively by healthcare professionals; non-technical solutions, such as personal assistance, guide dogs or lip-reading; implanted devices; financial support.
Concept Being Classified:
goods, health
Statistical Units:
Products (including devices, equipment, instruments and software).
Main Principles:
Function of the products
Relationships to Other International Classifications:
Related To:
Major Differences (Scope, Structure, and Concepts):
ISO 9999:2011, Assistive products for persons with disability - Global Medical Device Nomenclature
The GMDN is a system of internationally agreed generic descriptors used to identify all medical device products. On the other hand, ISO 9999 is a classification for assistive products.
Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined descriptive Preferred Term, with which all specific devices have substantially similar generic features. All GMDN terms have the following data elements.
The main purpose of the GMDN is to provide health authorities and regulators, health care providers, medical device manufacturers and suppliers, conformity assessment bodies and others with a single generic naming system that will support patient safety.
Classification Structure
Definition of Structure:
Level:
Level Name:
Code Format:
Number of Items:
Level 1
Class
04
12 items
Level 2
Subclass
04 03
130 items
Level 3
Division
04 03 03
781 items
Remarks:
Classes 00, 01, 02 and 90 to 99 and the associated subclasses and divisions are reserved for national applications. The position “89” is reserved for assistive products which are categorized “other” for the national level only. In addition, further levels may be added to any part of the classification to serve national or local purposes.
Criteria for Definition of Levels:
Titles at class level generally describe a broad area of function of the product. Titles at subclass level describe a special function within the broad area covered by the class. Titles at division level refer to particular products covered by the subclass. Classes are created in such a manner that they do not overlap in the described broad function of other classes. The subclasses are created in such a manner that they do not overlap in the specific function of other subclasses. The divisions are created in such a manner that they do not overlap with products in other divisions.
Revision Information
Chronology of revisions/versions of the classification:
Year Adopted:
Title or Version Number:
Website:
-
ISO 9999:2007 Assistive products for persons with disability / Fourth edition
Official Adopting Entity:
International Organization for Standardization
Coordinating Entity:
ISO TC 173/SC 2
Next Review:
2016
Reason for Latest Revision:
In order to contine a work for harmonization between ISO 9999 and the environmental factors from ICF, International Classification of Functioning, Disability and Health.
The major change was the addition of a new class, “Assistive Products for Employment and Vocational Training.”
Supporting Documents
Coding Index Available:
Yes
Index Website:
Available Formats:
Print, PDF
Training Materials and Other Documents:
N/A
Contact Information
Agency / Office:
Japanese Industrial Standards Committee
Unit:
Technical Regulations, Standards & Conformity Assessment Policy Unit, Ministry of Economy, Trade and Industry
Contact Name:
Niko Kato
Email:
Telephone:
+81 3 35 01 94 71
Fax:
+81 3 35 80 86 37
Address:
Japanese Industrial Standards Committee
Technical Regulations, Standards & Conformity Assessment Policy Unit
Ministry of Economy, Trade and Industry
1-3-1, Kasumigaseki, Chiyoda-ku
Tokyo 100 - 8901
Japan