medical device

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 purposes 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,

—

disinfection of medical devices,

—

providing information for medical purposes by means of in vitro examination of specimens derived from the human body,

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

Note 1

The term medical device includes in vitro diagnostic medical devices.

Note 2

This is the definition adopted by the GHTF in Reference [37].

Note 3

See Clause 3 of ISO 13485:2003 for additional examples of medical devices.

Bron

ISO 13485:2003, definition 3.7

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.47

medical device

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