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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.
Other StandardsIEC60601-2-33 Medical Electrical Equipment--Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Available from International Electrotechnical Commission (IEC), 3, rue de Varemb, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch. ISO14971 Medical Devices--Application of Risk Management to Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org. ISO/IECGuide51 Safety Aspects--Guidelines for their Inclusion in Standards ISOTS10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device
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
ICS Number Code 11.040.01 (Medical equipment in general)
UNSPSC Code 42201600(Medical magnetic resonance imaging MRI products)
ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, ASTM International, West Conshohocken, PA, 2013, www.astm.orgBack to Top