Device safety

Codes used to identify medical devices safety characteristics. These codes are taken from the NCI Thesaurus and are provided here as a suggestive example.

Copyright Statement:

MRI safety definitions reprinted, with permission, from F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. See ASTM F2503.

This value set includes codes from the following code systems:

  • Include these codes as defined in urn:oid:2.16.840.1.113883.3.26.1.1
    CodeDisplayDefinition
    C106046Magnetic Resonance ConditionalA device with demonstrated safety in the MR environment within defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the radiofrequency fields. Additional conditions, including specific configurations of the item, may be required. See ASTM F2503
    C106045Magnetic Resonance SafeThe device poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic. See ASTM F2503
    C106047Magnetic Resonance UnsafeThe device which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. See ASTM F2503
    C113844Labeling does not Contain MRI Safety InformationInformation on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labeling by the labeler.
    C101673Labeled as Containing Natural Rubber LatexThe device label indicates natural rubber latex as a component.
    C106038Not Made with Natural Rubber LatexThe composition of the materials of an item do not contain natural rubber latex.
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