Device safety
draftCodes used to identify medical devices safety characteristics. These codes are taken from the [NCI Thesaurus](https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf) and are provided here as a suggestive example.
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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:2.16.840.1.113883.3.26.1.1Code Display Definition C106046 Magnetic Resonance Conditional A 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 C106045 Magnetic Resonance Safe The 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 C106047 Magnetic Resonance Unsafe The device which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. See ASTM F2503 C113844 Labeling does not Contain MRI Safety Information Information on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labeling by the labeler. C101673 Labeled as Containing Natural Rubber Latex The device label indicates natural rubber latex as a component. C106038 Not Made with Natural Rubber Latex The composition of the materials of an item do not contain natural rubber latex.
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <h2>Device safety</h2>\n <div>\n <p>Codes used to identify medical devices safety characteristics. These codes are taken from the \n <a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">NCI Thesaurus</a> and are provided here as a suggestive example.\n </p>\n\n </div>\n <p>\n <b>Copyright Statement:</b>\n </p>\n <div>\n <p>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 \n <a href=\"https://www.astm.org/Standards/F2503.htm\">ASTM F2503</a>.\n </p>\n\n </div>\n <p>This value set includes codes from the following code systems:</p>\n <ul>\n <li>Include these codes as defined in \n <code>urn:oid:2.16.840.1.113883.3.26.1.1</code>\n <table class=\"none\">\n <tr>\n <td style=\"white-space:nowrap\">\n <b>Code</b>\n </td>\n <td>\n <b>Display</b>\n </td>\n <td>\n <b>Definition</b>\n </td>\n </tr>\n <tr>\n <td>C106046</td>\n <td>Magnetic Resonance Conditional</td>\n <td>A 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</td>\n </tr>\n <tr>\n <td>C106045</td>\n <td>Magnetic Resonance Safe</td>\n <td>The 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</td>\n </tr>\n <tr>\n <td>C106047</td>\n <td>Magnetic Resonance Unsafe</td>\n <td>The device which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. See ASTM F2503</td>\n </tr>\n <tr>\n <td>C113844</td>\n <td>Labeling does not Contain MRI Safety Information</td>\n <td>Information on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labeling by the labeler.</td>\n </tr>\n <tr>\n <td>C101673</td>\n <td>Labeled as Containing Natural Rubber Latex</td>\n <td>The device label indicates natural rubber latex as a component.</td>\n </tr>\n <tr>\n <td>C106038</td>\n <td>Not Made with Natural Rubber Latex</td>\n <td>The composition of the materials of an item do not contain natural rubber latex.</td>\n </tr>\n </table>\n </li>\n </ul>\n </div>",
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}| Title | Version | Status | Publisher | Date |
|---|---|---|---|---|
| Device safety | 4.0.1 | draft | HL7 (FHIR Project) | - |
| Device Safety | 5.0.0 | draft | HL7 (FHIR Project) | - |