(ISO/DIS 10993-1) Any instrument, apparatus, appliance, material, or other article, including software, whether used alone or in combination, intended by the manufacturer to be used for human beings solely or principally for the purpose of:- diagnosis, prevention, monitoring, treatment, or alleviation of disease;- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;- investigation, replacement, or modification of the anatomy or of a physiological process;- control of conception;and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.Note 1 – Devices are different from drugs, and their biological evaluation requires a different approach.Note 2 – Use of the term “medical device” includes dental devices.