Medical Device
medical device
med·i·cal de·vice
Definitions related to medical devices:
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(device) 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. (FDA)CDISC TerminologyClinical Data Interchange Standards Consortium (CDISC), 2021
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(medicaldevice) A device with direct or indirect therapeutic purpose. Values for EntityCode when EntityClass = "DEV"NCI Health Level 7 VocabularyU.S. National Cancer Institute, 2018
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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.NCI Dictionary of Cancer TermsU.S. National Cancer Institute, 2021
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Any physical object that is useful for prevention, diagnosis, monitoring, or treatment of disease or other conditions.NCI ThesaurusU.S. National Cancer Institute, 2021
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Medical device means 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.CDISC TerminologyClinical Data Interchange Standards Consortium (CDISC), 2021
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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.BRIDG Model DictionaryBiomedical Research Integrated Domain Group, 2019
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(biomedical equipment) Any instrument used in biomedical research or medical practice.CRISP ThesaurusNational Institutes of Health, 2006
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