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any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of


This is a concrete item and can be implemented directly

Term: medical device; 
Plural: medical devices; 


NOTE 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF)

NOTE 2 to entry: products, which could be considered to be medical devices in some jurisdictions but for which there is not yet a harmonized approach, are:

NOTE 3 to entry: Accessories intended specifically by manufacturers to be used together with a “parent” medical device to enable that medical device to achieve its intended purpose, should be subject to this International Standard.


Diagrammatic representation

Simple graph - medical device

Required associations

Optional associations


    healthcare resource
medical device


medical device
    automatic medical device