Medical Device

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16830

An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. EXAMPLE(S): tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter OTHER NAME(S): Equipment NOTE(S):

Any 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, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. EXAMPLE(S): tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter.

An instrument, tool, machine, test kit, or implant that is used to prevent, diagnose, or treat disease or other conditions. Medical devices range from tongue depressors to heart pacemakers and medical imaging equipment.

Any 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 or more specific medical purpose(s). NOTE: Specific medical purposes include 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 by means of in vitro examination of specimens derived from the human body; and 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 intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]

C16830

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C118169

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C116977

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C66830

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C132298

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61410

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C159503

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C67497

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C99078

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C159501

BRIDG

CDISC

CTRP

FDA

CDISC-GLOSS

Any physical object that is useful for prevention, diagnosis, monitoring, or treatment of disease or other conditions.

Medical Device

Device

Medical Device

DEVICE

medical device

Medical Devices

Medical Device

Medical_Device

Medical Device

Thesaurus:C16830

Medical Device

Medical Device

C0025080

http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103