MRI scanner

Why is ASTM F2503-23 Important?

September 26, 2023 4:49 pm Published by


ASTM F2503 is a standard developed by ASTM International that outlines safety practices and guidelines for items used in and around magnetic resonance imaging (MRI) scanners. Its primary goal is to provide a universal set of icons and terms that quickly convey the safety status of items near MRI machines.

 The standard establishes a clear terminology to categorize items as MR Safe, MR Unsafe, or MR Conditional, depending on their compatibility with MRI environments. These icons and terms help medical professionals, patients, and equipment manufacturers understand the potential risks and compatibility of various objects with MRI environments.






Why is ASTM F2503-23 Important?

The electromagnetic fields associated with MRI machines can interact with objects, potentially causing displacement, heating, vibration, or malfunction. ASTM F2503 provides guidance on the various ASTM/ISO testing standards available to evaluate these hazards, and how to label items depending on their performance on the various safety tests.

 

For instance, an “MR conditional” item may be scanned under one set of MRI conditions (e.g., 3 Tesla scanner) but not under different conditions (e.g., 1.5 Tesla scanner). This standardized approach enhances patient safety and prevents misunderstandings about the compatibility of items with MRI environments.

 

The Evolution of Terminology

In the past, terms like “MR safe” and “MR compatible” were used, but they didn’t adequately convey the diverse conditions and risks posed by different MRI environments. The revised terminology in both the 2020 and 2023 editions uses three categories: MR Safe, MR Unsafe, and MR Conditional.

 

This new classification system ensures that the safety of an item is clearly defined in relation to specific MRI conditions, addressing the complexities and variability of the various electromagnetic fields/MRI scanners.

Ensuring Safety Beyond Imaging

One of the practical outcomes of ASTM F2503-23 is the requirement to mark items intended for use near MRI machines (e.g., fire extinguishers, oxygen tanks), not just implanted medical devices. The standard provides guidance on how to label and secure items that might accidentally or intentionally be brought into the MRI environment.

 

Items are labeled as “MR Safe,” “MR Unsafe,” or “MR Conditional” based on their interactions with the electromagnetic fields, which allows medical professionals to quickly identify whether an object can be safely used in the MRI environment.

 

Important to note that some items may contain magnetic/metallic subcomponents that are not obvious, and thus would not have undergone MR safety testing/labelling. Some examples would be certain clothing items, pillows, batteries. Even some non-metallic fibers can experience dangerous heating (e.g., Carbon fiber or some polymers)

 

Potential hazards in the MR environment

Beyond instructions for safety labelling, ASTM F2503 also lists other ASTM/ISO testing standards for evaluating potential hazards for items near/in MRI scanners. Some of the basic hazards (e.g., force, torque, RF-induced heating) are covered by ASTM standards listed below, while the more comprehensive ISO TS 10974 covers more hazards that apply to active implants (e.g., pacemakers):

  • Force – ASTM F2052
  • Torque – ASTM F2213
  • RF Field-induced heating, rectified voltage – ASTM F2182, ISO 10974
  • Gradient field-induced heating/vibration/voltage – ISO 10974
  • Device malfunction – ISO 10974
  • Image artifacts – ASTM F2119



Table X1.1 List of Potential Test Methods for Associated Hazards (From ASTM F2503-23)
Main issues General Hazard to the patient/other individuals in the MR environment Risk analysis and/or Testing Related to Interaction Test method or other standard
MR safety Force
Torque
Heat
Static magnetic field-induced displacement
Static magnetic field-induced torque
Radiofrequency (RF) field-induced heating
Gradient field-induced heating
ASTM F2052
ASTM F2213
ASTM F2182
ISO TS 10974
Vibration Gradient field-induced vibration ISO TS 10974
Extrinsic electric potential Gradient field-induced (lead) voltage ISO TS 10974
Rectification RF field-induced rectified (lead) voltage ISO TS 10974
Malfunction (of a device) Static magnetic field-induced malfunction
RF field-induced device malfunction
Gradient field-induced malfunction
Combined field test
ISO TS 10974
ISO TS 10974
ISO TS 10974
ISO TS 10974
MR image quality Diagnostic error Image artifacts ASTM F2119



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This post was written by Blaine Chronik

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