WK82200 - New Guide for Assessing Non-Implanted Items for Safety in the Magnetic Resonance Environment Outside an MR System | ASTM
Work Item
ASTM WK82200
New Guide for Assessing Non-Implanted Items for Safety in the Magnetic Resonance Environment Outside an MR System
1. Scope
1. Scope
1.1 This guide provides methods for evaluating the safety of non-implanted items within the magnetic resonance (MR) environment but outside of the bore of the MR system.
1.2 This guide is intended for the evaluation of items that are not in contact with the patient in the MR environment. Items intended to contact the patient require additional evaluation and are outside the scope of this standard.
1.3 For items which include components intended to contact the patient during an MR examination, this guide covers only the portions of the item that remain outside the MR system. Portions of an item that contact the patient during an MR exam require additional evaluation and are outside the scope of this standard.
Note 1: For example, ventilators or patient monitors that remain outside the MR system bore are within the scope of this standard. Tubing, electrodes or leads that contact the patient are outside the scope of this standard.
1.1 All items shall be evaluated for magnetically induced displacement.
1.2 Items with essential performance requirements within the MR environment shall be evaluated for malfunction due to exposure to the fields produced by the MR system.
1.4 This guide should be used with Practice F2503 to develop MRI safety labeling for the assessed item.
1.5 Image artifact is outside the scope of this guide.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard with the exception of Gauss (G), which is a cgs measurement of magnetic flux density.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywords
MRI Safety
Rationale
The standard will be used by manufacturers of medical devices and other items to develop MRI safety labeling for non- implanted devices and other items intended to remain outside an MRI system. It may also be used by test houses or clinical practitioners.
