Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4 R3

4.4.1.121 ValueSet http://hl7.org/fhir/ValueSet/device-safety

Orders and Observations Work Group Maturity Level: 1Draft Use Context: Not Intended for Production use, Not Intended for Production use

This is a value set defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/ValueSet/device-safety
Version:5.0.0-ballot
Name:DeviceSafety
Title:
Status:draft
Definition:

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

Committee:Orders and Observations Work Group
OID:2.16.840.1.113883.4.642.3.213 (for OID based terminology systems)
Copyright:

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 .

Flags:Experimental, Immutable

This value set is used in the following places:

4.4.1.121.1 Content Logical Definition

  • 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.

 

See the full registry of value sets defined as part of FHIR.

Explanation of the columns that may appear on this page:

LvlA few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - see Code System for further information
SourceThe source of the definition of the code (when the value set draws in codes defined elsewhere)
CodeThe code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
DisplayThe display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
DefinitionAn explanation of the meaning of the concept
CommentsAdditional notes about how to use the code