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The Global Medical Device Nomenclature (GMDN) provides
a standardized method for describing and identifying medical devices
in an unambiguous manner, and has been adopted by an increasing number
of regulatory authorities worldwide. Wherever possible, the device
descriptions on the List of Medical Devices are given in GMDN preferred
terms (see below).
The general structure of the GMDN is in accordance with the requirements
of the international standard ISO 15225. Briefly, the GMDN structure
is based on the three level data structure in fig. 1.
Fig.1
The device type level of this three level structure is not part
of the GMDN nomenclature, but consists of identifiers at the manufacturer's
naming level, such as makes and models.
The nomenclature level of the structure consists of device categories
and generic device groups. Presently the GMDN includes 13 established
device categories and more than 7000 device groups.
The established device categories are:
- Active implantable devices
- Anaesthetic and respiratory devices
- Dental devices
- Electro mechanical medical devices
- Hospital hardware
- In vitro diagnostic devices
- Non-active implantable devices
- Ophthalmic and optical devices
- Reusable instruments
- Single use devices
- Technical aids for disabled persons
- Diagnostic and therapeutic radiation devices
- Complementary therapy devices
Terms at the generic device group level that are included in the
GMDN can be of one of three types, namely preferred terms, template
terms, and synonym terms:
| 1. |
Preferred terms are all the names available for the purpose
of categorization of medical devices. It is a term representing
a set of devices having the same or similar intended uses
or commonality of technology allowing them to be classified
in a generic manner not reflecting specific characteristics
such as brand or trade names. Examples of preferred terms:
...
- Humidifier, heated
- Incubator, infant, transportable
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| 2. |
Template terms are broad names that are used to collectively
group similar preferred terms - a kind of heading. Examples
of template terms:
- Cuff, internal, <specify> (which is the template
term for a group of preferred terms including "Cuff,
internal, nerve" and "Cuff, internal, vascular")
- Incubator, infant, <specify> (which is the template
term for a group of preferred terms including "Incubator,
infant, open", "Incubator, infant, stationery"
and "Incubator, infant, vascular")
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| 3. |
Synonym terms are navigational terms (entry terms) used in
the nomenclature. A synonym term is a common use or familiar
name. It is an alternative term for a preferred or template
term that is linked to the preferred or template term to direct
persons who use the synonym to the preferred or template term.
Examples of synonym terms:
- Module, patient monitoring system, carbon dioxide (synonymous
with the preferred term "Patient monitoring system
module, carbon dioxide")
- Diathermy unit, surgical (synonymous with the preferred
term "Electrosurgical unit, general purpose")
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| Important notices
