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Definition

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

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

— investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life,

— control of conception,

— cleaning, disinfection, or sterilization of medical devices,

— providing information by means of in vitro examination of specimens derived from the human body,

and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means

 

This is a concrete item and can be implemented directly

Term: medical device; 
Plural: medical devices; 

Notes

Note 1 to entry: products which could be considered to be medical devices in some jurisdictions but not in others include:

— disinfection substances,

— aids for persons with disabilities,

— devices incorporating animal and/or human tissues,

— devices for in-vitro fertilization or assisted reproductive technologies.

Examples

Diagrammatic representation

Simple graph - medical device

Required associations

Optional associations

one or more integrator integrates a number of medical devices

Generalisations

        asset
    product
medical device

Specialisations

medical device