A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug). Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.
Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing,implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering. wikipedia
Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific 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,
- Disinfection of medical devices,
- Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
Medical Device References
Why we warm patients.