ASTM F2503 - 13

    Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

    Active Standard ASTM F2503 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.02


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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.

    4.2 Potential direct and indirect causes of hazards:

    4.2.1 Direct causes:

    4.2.1.1 mechanical causes, including magnetically induced displacement force, torque, and vibration

    4.2.1.2 electromagnetic causes, including induction (heating, stimulation) and discharge (spark gap)

    4.2.1.3 acoustic causes

    4.2.2 Indirect causes:

    4.2.2.1 malfunction of items, for example of vital components such as valves, monitors and pumps

    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. Scope

    1.1 This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment.

    1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking.

    1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons.

    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).

    1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.6 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.

    Other Standards

    IEC60601-2-33 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

    ASTM Standards

    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 Code

    ICS Number Code 11.040.01 (Medical equipment in general)

    UNSPSC Code

    UNSPSC Code 42201600(Medical magnetic resonance imaging MRI products)


    DOI: 10.1520/F2503

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