ASTM F2503-23e1

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

SIGNIFICANCE AND USE
4.1 Interactions of items with the MR environment have resulted in serious injuries and death of patients and other individuals. This practice lists hazards that may be present in the MR environment. It specifies marking of items anticipated to enter the MR environment and recommends information that should be included in the associated labeling.  
4.2 This practice provides a uniform system of visual icons and terms for marking items for use in the MR environment.
SCOPE
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
Note 1: “Medical devices and other items” will be referred to as “items” for the remainder of this practice.  
1.2 The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.  
1.3 MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination (see X1.12).  
1.4 The values stated in SI units are to be regarded as standard.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Mar-2023
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Apr-2023
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Apr-2023
• Referred By: ASTM F3437-23 - Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 01-Apr-2023
• Referred By: ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Apr-2023
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 01-Apr-2023
• Referred By: ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
• Effective Date: 01-Apr-2023
• Referred By: ASTM F366-17 - Standard Specification for Fixation Pins and Wires
• Effective Date: 01-Apr-2023
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2182-19e2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
• Effective Date: 01-Apr-2023
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Apr-2023

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
´1
Designation: F2503 − 23
Standard Practice for
Marking Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment
This standard is issued under the fixed designation F2503; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—References in 6.3.3 were editorially corrected in October 2023.
1. Scope the edition cited applies. For undated references, the latest
edition of the referenced document (including any amend-
1.1 This practice applies to medical devices and other items
ments) applies.
that are anticipated to enter the magnetic resonance (MR)
2.2 ASTM Standards:
environment.
F2052 Test Method for Measurement of Magnetically In-
NOTE 1—“Medical devices and other items” will be referred to as
duced Displacement Force on Medical Devices in the
“items” for the remainder of this practice.
Magnetic Resonance Environment
1.2 The practice specifies the marking of items anticipated
F2119 Test Method for Evaluation of MR Image Artifacts
to enter the MR environment by means of terms and icons, and
from Passive Implants (Withdrawn 2022)
recommends information that should be included in the label-
F2182 Test Method for Measurement of Radio Frequency
ing.
Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging
1.3 MR image artifacts are not in the scope of the manda-
F2213 Test Method for Measurement of Magnetically In-
tory portions of this practice because they do not present a
duced Torque on Medical Devices in the Magnetic Reso-
direct safety issue resulting from specific characteristics of the
nance Environment
MR examination (see X1.12).
2.3 Other Standards and Documents:
1.4 The values stated in SI units are to be regarded as
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33:
standard.
Particular Requirements for the Basic Safety and Essential
1.5 This standard does not purport to address all of the
Performance of Magnetic Resonance Equipment for
safety concerns, if any, associated with its use. It is the
Medical Diagnosis
responsibility of the user of this standard to establish appro-
ISO 14971 Medical Devices—Application of Risk Manage-
priate safety, health, and environmental practices and deter-
ment to Medical Devices
mine the applicability of regulatory limitations prior to use.
ISO/IEC Guide 51 Safety Aspects—Guidelines for their
1.6 This international standard was developed in accor-
Inclusion in Standards
dance with internationally recognized principles on standard-
ISO TS 10974 Assessment of the Safety of Magnetic Reso-
ization established in the Decision on Principles for the
nance Imaging for Patients with an Active Implantable
Development of International Standards, Guides and Recom-
Medical Device
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3. Terminology
3.1 Definitions:
2. Referenced Documents
2.1 The following referenced documents are indispensable
for the application of this practice. For dated references, only
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This practice is under the jurisdiction of ASTM Committee F04 on Medical and The last approved version of this historical standard is referenced on
Surgical Materials and Devices and is the direct responsibility of Subcommittee www.astm.org.
F04.15 on Material Test Methods. Available from International Electrotechnical Commission (IEC), 3, rue de
Current edition approved April 1, 2023. Published May 2023. Originally Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
approved in 2005. Last previous edition approved in 2020 as F2503 – 20. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2503-23E01. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F2503 − 23
3.1.1 active item—an item that serves its functions with the 3.1.9.1 Discussion—Additional conditions, including spe-
supply of electrical power (definition modified from Test cific configurations of the item, may be required.
Method F2213, passive implant). 3.1.10 MR environment—three-dimensional volume sur-
rounding the MR magnet that contains both the Special
3.1.2 cylindrical MR system—MR system with a substan-
Environment (Faraday shielded volume) and the B Hazard
tially cylindrical patient aperture, and a static magnetic field
Area (space around the MR equipment where the static
(B ) aligned with the long axis of the cylinder. IEC 60601-2-33
magnetic field can cause harm). This volume is the region in
3.1.2.1 Discussion—This is inclusive of elliptical patient
which an item might pose a hazard from exposure to the
aperture systems.
electromagnetic fields produced by the MR equipment and
3.1.3 hazard—potential source of harm. ISO/IEC Guide 51
accessories, and for which access control is part of the risk
mitigation. Adapted from IEC 60601-2-33
3.1.4 item—object that might be brought into the MR
3.1.11 MR equipment—medical electrical equipment which
environment.
is intended for in vivo magnetic resonance examination of a
3.1.5 magnetically induced displacement force—force pro-
patient comprising all parts in hardware and software from the
duced when an item is exposed to the spatial field gradient.
supply mains to the display monitor. Adapted from IEC
This force may cause the item to translate.
60601-2-33
3.1.6 magnetically induced torque—torque produced when
3.1.12 MR examination—process of acquiring data by mag-
an item is exposed to a magnetic field. This torque may tend to
netic resonance from a patient. IEC 60601-2-33
cause the item to align itself along the magnetic field in an
3.1.13 MR Safe—an item that poses no known hazards
equilibrium direction that induces no torque.
resulting from exposure to any MR environment. MR Safe
3.1.7 magnetic resonance (MR)—resonant absorption of items are composed of materials that are electrically
electromagnetic energy by an ensemble of atomic nuclei nonconductive, nonmetallic, and nonmagnetic.
situated in a magnetic field. IEC 60601-2-33
3.1.13.1 Discussion—An item composed entirely of electri-
3.1.8 medical device—any instrument, apparatus,
cally nonconductive, nonmetallic, and nonmagnetic materials
implement, machine, appliance, implant, reagent for in vitro
may be determined to be MR Safe by providing a scientifically
use, software, material, or other similar or related article,
based rationale rather than test data. Examples of MR Safe
intended by the manufacturer to be used, alone or in
items are a cotton blanket or a silicone catheter.
combination, for human beings for one or more of the specific
3.1.14 MR Unsafe—an item which poses unacceptable risks
medical purpose(s) of:
to the patient, medical staff, or other persons within the MR
(1) Diagnosis, prevention, monitoring, treatment, or alle-
environment.
viation of disease;
3.1.14.1 Discussion—ISO 14971 Medical devices–Applica-
(2) Diagnosis, monitoring, treatment, alleviation of or com-
tion of risk management to medical devices, includes a process
pensation for an injury;
for evaluating risks, including identifying unacceptable risks.
(3) Investigation, replacement, modification, or support of
MR Unsafe items include items such as a pair of ferromagnetic
the anatomy or of a physiological process;
scissors.
(4) Supporting or sustaining life;
3.1.15 passive item—an item that serves its functions with-
(5) Control of conception;
out the supply of electrical power (definition modified from
(6) Disinfection of medical devices;
Test Method F2213, passive implant).
(7) Providing information for medical purposes by means
3.1.16 radio frequency (RF) magnetic field—the magnetic
of in vitro examination of specimens derived from the human
field in MRI that is used to flip the magnetic moments. The
body;
frequency of the RF field is γB where γ is the gyromagnetic
and does not achieve its primary intended action by
constant, 42.56 MHz/T for protons, and B is the static
pharmacological, immunological, or metabolic means, in or on
magnetic field in Tesla.
the human body, but which may be assisted in its intended
function by such means.
3.1.17 safety—freedom from unacceptable risk. ISO 14971
3.1.8.1 Discussion—Products which may be considered to
3.1.18 spatial field gradient (SFG)—spatial rate of change
be medical devices in some jurisdictions but not in others
W
of the main magnetic field |π|B||. IEC 60601-2-33
include:
3.1.18.1 Discussion—Attractive magnetic forces on magne-
(1) Disinfection substances;
tizable or saturated ferromagnetic objects scale linearly with
(2) Aids for persons with disabilities;
SFG.
(3) Devices incorporating animal and/or human tissues;
(4) Devices for in vitro fertilization or assisted reproduc-
3.1.19 specific absorption rate (SAR)—radio frequency
tion technologies. ISO 13485
power absorbed per unit of mass (W/kg). IEC 60601-2-33
3.1.9 MR Conditional—an item with demonstrated safety in
4. Significance and Use
the MR environment within defined conditions including
conditions for the static magnetic field, the time-varying 4.1 Interactions of items with the MR environment have
gradient magnetic fields, and the radiofrequency fields. resulted in serious injuries and death of patients and other
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F2503 − 23
individuals. This practice lists hazards that may be present in practically. For items for which direct marking is not practical,
the MR environment. It specifies marking of items anticipated the MR marking shall be included in the labeling. For both
to enter the MR environment and recommends information that implanted and non-implanted items, the MR marking may be
should be included in the associated labeling. placed on the product packaging label (for example, on the
box), however the package label should clearly indicate the
4.2 This practice provides a uniform system of visual icons
item(s) inside the packaging to which the MR marking applies
and terms for marking items for use in the MR environment.
(for example, implant only or implant and delivery system).
5. Hazards Pertaining to Items Entering the MR
6.3 Minimum Information—As a result of the assessment
Environment
described in Section 5, mark the item as MR Safe, MR
5.1 For items entering the MR environment that could Conditional, or MR Unsafe using the icons as shown in Tables
interact with the static magnetic field associated with an MR 1 and 2.
scanner, assess static magnetic field interactions. 6.3.1 The MR Safe icon consists of the letters “MR”
5.1.1 Static magnetic field interactions can include, as surrounded by a green square (Table 1 and Figs. 1 and 2). Two
applicable, force, torque, and malfunction. options are given. When color reproduction is not practical, the
icon may be printed in black and white (Table 2, Figs. 3 and 4).
5.2 For items entering the MR environment that could
The use of the colored icon is strongly encouraged for the
interact with the time varying gradient field (dB/dt), assess
added visibility and information provided by the color. For
time varying gradient magnetic field (dB/dt) interactions.
both color and black and white options in Tables 1 and 2, the
5.2.1 Switched gradient magnetic field (dB/dt) interactions
option that is most visible for the individual application should
can include, as applicable, gradient-induced heating, vibration,
be chosen.
electrical extrinsic potential (induced voltages), and malfunc-
6.3.2 The MR Conditional icon consists of the letters “MR”
tion.
within a yellow equilateral triangle with a thick black band
5.3 For items entering the MR environment that could
around the perimeter (Table 1 and Fig. 5). The triangle is
interact with the RF field, assess RF field interactions.
oriented with its horizontal side below the letters “MR.” When
5.3.1 RF-induced interactions can include, as applicable,
color reproduction is not practical, the icon may be printed in
RF-induced heating, RF rectification, and RF-induced mal-
black and white (Table 2 and Fig. 6). The use of the colored
function.
icon is strongly encouraged for the added visibility and
information provided by the color.
5.4 Other possible considerations for assessment can
6.3.2.1 For MR Conditional items, the item labeling (in-
include, but are not limited to, interaction between different
structions for use, package inserts, operator manual, patient
items. Also see X1.4.
information card, patient and physician information pamphlets,
NOTE 2—MR image artifacts, while not considered a direct safety issue
as appropriate) shall include appropriate information from
(see 1.3), should be considered. The accompanying documentation should
Section 5.
contain a statement concerning item-induced MR image artifacts.
5.5 An assessment may include testing. See Table X1.1 for
a list of some of the potential hazards and associated test
methods.
TABLE 1 Requirements for Colored MR Icons
5.6 An assessment may include computational simulations
Icon Geometric Shape and Appearance Meaning
(for example, RF-induced heating).
A square
5.7 An assessment may include leveraging previous results
MR Safe
with appropriate justification and/or scientific rationale.
or
6. MR Marking
An equilateral triangle with radiused outer
6.1 The marking method shall not compromise performance
corners
or function of the marked item and should provide legibility
over the anticipated service life of the item.
6.2 Items that are anticipated to enter the MR environment MR Conditional
vary widely in size, and the amount of information that can
practically be included in marking varies accordingly. For
implanted items, the MR marking shall be included in the
labeling (including the instructions for use, package inserts,
A circle with a diagonal bar
patient and physician manuals, patient information card) and
may be included on the item. Non-implanted items, where
feasible, shall be marked with the appropriate MR icons. If a
MR Unsafe
non-implanted item is MR Conditional, where feasible, include
the conditions for safety in the MR environment on the item as
well as in the labeling. Some items (for example, small or very
thin ones) do not provide adequate surfaces that can be marked
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F2503 − 23
TABLE 2 Requirements for Black and White MR Icons with accessories is MR Conditional. For example, indicate “stent only” for
a system that consists of stent plus delivery catheter.
Icon Geometric Shape and Appearance Meaning
A square 6.3.3 The MR Unsafe marking consists of the letters “MR”
surrounded by a red circle with a diagonal red bar across the
letters extending from the upper left quadrant to the lower right
MR Safe
or
quadrant of the circle and oriented at 45° from the horizontal
(Table 1 and Fig. 9). When color reproduction is not practical,
the icon may be printed in black and white (Table 2 and Fig.
An equilateral triangle with radiused outer
10). The use of the colored icon is strongly encouraged for the
corners
added visibility and information provided by the color.
6.4 The icons shall comply with the layout requirements
given below. The colors are given in Table 3. Note that the
MR Conditional
colors represented in an electronic or paper copy of this
practice may not match the colors as defined in Table 3.
6.4.1 MR Safe Icon, Color Option 1 (Fig. 1):
A circle with a diagonal bar
MR Unsafe
FIG. 1 Color Option 1
6.4.1.1 The colors of the MR Safe icon shall be as follows
for option 1:
(1) Background color: green.
(2) Letters ‘MR’: white.
6.3.2.2 The MR Conditional icon on non-implanted items
(3) The letters ‘MR’ shall be capitalized, in Arial font and
may include a supplementary marking. This marking should
centered in the square. The letters shall be sized as large as
include the appropriate information from Section 5 and de-
possible to be contained within the green square, but not
scribes the conditions for which the item has been demon-
touching the border of the square.
strated to be MR Conditional. The supplementary marking
6.4.2 MR Safe Icon, Color Option 2 (Fig. 2):
consists of text surrounded by a rectangular frame (Figs. 7 and
8).
6.3.2.3 For all items external to the body of a person for
which it is technically feasible, labeling for MR Conditional
items shall appear on the item and include conditions for safety
in the MR environment from Section 5.
FIG. 2 Color Option 2
NOTE 3—Adding that information on the item allows immediate access
to the MR conditions.
NOTE 4—This supplementary marking of information for safe usage 6.4.2.1 The colors of the MR Safe icon shall be as follows
may be particularly useful for inclusion on non-implanted items that are
for option 2:
anticipated to enter the MR environment, such as anesthesia equipment,
(1) Background color: white.
power injectors, medication pumps, patient transport equipment, physi-
(2) Letters ‘MR’: green.
ological monitoring equipment, monitors, interventional equipment, step
(3) Frame: green. The width of the frame shall be approxi-
stools, IV poles, carts, room furnishings, item packaging and labeling, etc.
NOTE 5—This marking may also be used if one portion of a kit or item mately 10 % of the length of a side of the square.
TABLE 3 Examples from Color Order Systems for the Icon Colors
A
(DIN, RAL, Munsell, AFNOR, and NCS examples from ISO 3864-1:2)
AFNOR
DIN 5381
Color RAL Munsell NF X08-002 NCS Pantone
DIN 6164
and X08-010
Red 7,5 : 8,5 :3 RAL 3001 7,5R 4/14 N°2805 S 2080-R Pantone 1807 C
Yellow 2,5 : 6,5 : 1 RAL 1003 10YR 7/14 N°1330 S 1070-Y10R Pantone 1235 C
Green 21,7 : 6,5 : 4 RAL 6032 5G 4/9 N°2455 S 3060-G Pantone 3415 C
White N : 0 : 0,5 RAL 9003 N 9,5 N°3665 S 0500-N Pantone White
Black N : 0 :9 RAL 9004 N 1 N°2603 S 9000-N Pantone 6 C
A
©International Organization for Standardization (ISO). This material is reproduced from ISO 3864-1:2002 with permission of the American National Standards Institute
on behalf of ISO. No part of this material may be copied or reproduced in any form, electronic retrieval system or otherwise or made available on the Internet, a public
network, by satellite or otherwise without prior written consent of the American National Standards Institute (ANSI), 25 West 43rd Street, New York, NY 10036. Copies of
this practice may be purchased from the ANSI, [phone], http://webstore.ansi.org.
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F2503 − 23
(4) The letters ‘MR’ shall be capitalized, in Arial font and
centered in the square. The letters shall be sized as large as
possible, but not touching the border of the frame.
6.4.3 MR Safe Icon, Black and White Option 1 (Fig. 3):
FIG. 6 MR Conditional Icon Geometry, Black and White Option
(3) Letters ‘MR’: black.
FIG. 3 Black and White Option 1
(4) The letters ‘MR’ shall be capitalized, in Arial font and
sized as large as possible within the black frame, but not
6.4.3.1 For option 1 of the black and white version of the
touching the frame.
MR Safe icon, the colors shall be as follows:
6.4.7 Supplementary Marking for MR Conditional Items,
(1) Background color: black.
Color Option (Fig. 7):
(2) Letters ‘MR’: white.
(3) The letters ‘MR’ shall be capitalized, in Arial font and
centered in the square. The letters shall be sized as large as
possible, but not touching the border of the square.
6.4.4 MR Safe Icon, Black and White Option 2 (Fig. 4):
FIG. 7 Supplementary Marking for MR Conditional Items, Color
Option
6.4.7.1 For the color option of the MR Conditional Supple-
FIG. 4 Black and White Option 2 mentary marking, colors shall be as follows:
(1) Background color: yellow.
(2) Rectangular Frame: black.
6.4.4.1 For option 2 of the black and white version of the
(3) Text: black.
MR Safe icon, the colors shall be as follows:
(4) The safety color yellow shall cover at least 50 % of the
(1) Background color: white.
total area of the icon.
(2) Letters ‘MR’: black.
(5) The text shall be in Arial font.
(3) Frame: black. The width of the border shall be approxi-
6.4.8 Supplementary Marking for MR Conditional Items,
mately 10 % of the side length of the square.
Black and White Option (Fig. 8):
(4) The letters ‘MR’ shall be capitalized, in Arial font and
centered in the square. The letters shall be sized as large as
possible, but not touching the frame.
6.4.5 MR Conditional Icon, Color Option (Fig. 5):
FIG. 8 Supplementary Marking for MR Conditional Items, Black
and White Option
6.4.8.1 For the black and white option of the MR Condi-
tional Supplementary marking, the colors shall be as follows:
FIG. 5 MR Conditional Icon Geometry, Color Option
(1) Background color: white.
(2) Rectangular Frame: black.
6.4.5.1 The colors of the MR Conditional icon shall be as
(3) Text: black.
follows:
(4) The text shall be in Arial font.
(1) Background color: yellow.
6.4.9 MR Unsafe Icon, Color Option (Fig. 9):
(2) Triangular frame: black.
(3) Letters ‘MR’: black.
(4) The letters ‘MR’ shall be capitalized, in Arial font and
sized as large as possible within the black frame, but not
touching the frame.
6.4.6 MR Conditional Icon, Black and White Option (Fig.
6):
FIG. 9 MR Unsafe, Color Option
6.4.6.1 For the black and white version of the MR Condi-
tional icon, the colors of the icon shall be as follows:
(1) Background color: white. 6.4.9.1 The colors of the MR Unsafe icon shall be as
(2) Triangular frame: black. follows:
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F2503 − 23
(1) Background color: white.
(2) Circular frame and diagonal bar: red.
(3) Letters ‘MR’: black.
(4) The letters ‘MR’ shall be capitalized, in Arial font, and
sized as large as possible within the circular frame, but not
touching the frame.
6.4.10 MR Unsafe Icon, Black and White Option (Fig. 10): FIG. 10 MR Unsafe, Black and White Option
6.4.10.1 For the black and white version of the MR Unsafe
icon, the colors of the icon shall be as follows:
(1) Background color: white.
(2) Circular frame and diagonal bar: black.
7. Keywords
(3) Letters ‘MR’: black.
7.1 magnet; magnetic; medical devices; metals (for surgical
(4) The letters ‘MR’ shall be capitalized, in Arial font and
implants); MRI (magnetic resonance imaging); MR safety
sized as large as possible within the circular frame, but not
touching the frame.
APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 The intent of this practice is to provide needed in the MR environment. In short, when using the historical
information about the safety of items in and near MR scanners definitions it was impossible to definitively establish an item as
using a compact and easily recognized set of icons and terms. MR safe or MR compatible without also specifying the
The terms MR safe and MR compatible as first defined in 1997 conditions under which the item was tested. The current terms
in the FDA draft guidance document, “A Primer on Medical in this practice (MR Safe, MR Unsafe, and MR Conditional,
Device Interactions with Magnetic Resonance Imaging Section 3) assist in clearing up this confusion.
Systems,” were used to describe the safety of devices in and
NOTE X1.1—This revised terminology has not yet been applied to all
near MR equipment and accessories. The obsolete historical
items tested before the approval of Practice F2503. Therefore, there are
definitions are: items that still contain the prior terminology (that is, use the old terms MR
safe and MR compatible) in their labeling.
MR safe The device, when used in the MR environment, has
NOTE X1.2—IEC 60601-2-33 requires that every MR system come with
(obsolete been demonstrated to present no additional risk to
a compatibility technical specification sheet (CTSS) containing param-
definition) the patient or other individuals, but may affect the
eters that describe the MR equipment. The specification sheet is part of the
quality of the diagnostic information. The MR
conditions in which
...