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  • ASTM
    F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    Edition: 2013
    $103.58
    Unlimited Users per year

Description of ASTM-F2503 2013

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




ASTM F2503

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.

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

Other Standards

IEC 60601-2-33, Ed. Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis

Keywords

magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety;


ICS Code

ICS Number Code 11.040.01 (Medical equipment in general)


DOI: 10.1520/F2503

ASTM International is a member of CrossRef.

ASTM F2503

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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