Significance and Use
Medical devices and other items have caused serious injuries and death for patients and other individuals in the MR environment.
This practice provides a uniform system for marking to indicate the MR conditions that have been determined to be acceptable for a medical device or other item. It provides simple visual icons and terms which are intended to reduce injuries and other mishaps that occur when items that pose hazards in the MR environment are brought into the MR environment.
p id="s00002">1.1 This practice covers the marking of medical devices and other items to indicate their safety in the magnetic resonance (MR) environment.
1.2 The purpose of this practice is to (1) recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed, and (2) recommend information that should be included in the marking. It is recognized that direct marking on the item is not practical for implants and certain other medical devices. Where direct marking is not practical, this practice recommends that the marking be included in the labeling and on patient information cards (see 7.1).
1.3 Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
IEC 60601-2-33, Ed. Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety; Magnetic resonance testing; Marking; Medical devices/equipment; Safety;
ICS Number Code 11.040.01 (Medical equipment in general)
ASTM International is a member of CrossRef.
Citing ASTM Standards
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