Active Standard ASTM F2503 | Developed by Subcommittee: F04.15
Book of Standards Volume: 13.02
Historical (view previous versions of standard)
Significance and Use
4.1 Interactions of medical devices and other items with the MR environment has resulted in serious injuries and death of patients and other individuals. Additionally, hazards stemming from equipment malfunction are of concern. Section 4.2 lists possible direct and indirect causes of hazards in the MR environment.
4.3 This practice provides a uniform system for marking to indicate the conditions for which it has been determined that a medical device or other item may be safely placed and used in the MR environment. 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.
1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5).
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
Other StandardsIEC 60601-2-33, Ed. Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
ICS Number Code 11.040.01 (Medical equipment in general)
UNSPSC Code 42201600(Medical magnetic resonance imaging MRI products)