IEC 62570:2014

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. 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. The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice. IEC 62570 is integrating the unmodified text of ASTM F2503-13. It has been developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM.

Pratiques normalisées relatives au marquage des appareils médicaux et des éléments de sûreté divers dédiés aux environnements de résonance magnétique

L'IEC 62570:2014 s'applique aux pratiques de marquage des éléments qui pourraient être utilisés dans des environnements de résonance magnétique (RM). L'objectif de cette pratique est de marquer les éléments qui peuvent ne pas être installés dans un environnement de RM, mais aussi d'indiquer les informations qu'il convient d'intégrer au marquage. La norme spécifie le marquage permanent des éléments utilisés dans un environnement de RM via des termes et symboles. Les artefacts d'image à RM ne constituent pas un problème de performance et ne sont donc pas abordés dans cette pratique internationale normalisée. Les valeurs indiquées dans des unités SI doivent être considérées comme normalisées. Aucune autre unité de mesure n'est utilisée dans cette norme. L'IEC 62570 comprend le texte non modifié de la ASTM F2503-13. Elle a été établie par le sous-comité 62B: Appareils d'imagerie de diagnostic, du comité d'études 62 de l'IEC: Equipements électriques dans la pratique médicale, en collaboration avec la ASTM.

General Information

• Status: Published
• Publication Date: 25-Feb-2014
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 45 - TC 62/SC 62B/WG 45
• Current Stage: PPUB - Publication issued
• Start Date: 26-Feb-2014
• Completion Date: 28-Feb-2014

Relations

• Revised: IEC 62570:2025 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
• Effective Date: 14-Feb-2025

Overview

IEC 62570:2014 is an international standard that establishes the standard practice for marking medical devices and other items intended for use in the magnetic resonance (MR) environment. Developed by IEC Technical Committee 62, in collaboration with ASTM, this standard integrates the unmodified text of ASTM F2503-13 to provide a clear, uniform approach for labeling devices that may be exposed to magnetic resonance imaging (MRI) settings. The main purpose is to enhance safety by defining permanent markings, including specific terms and icons, for items that might present hazards or require special handling in the MR environment.

This standard addresses the need for clear communication to clinicians, technicians, and safety personnel regarding the compatibility and safety conditions for medical devices within MR environments. Importantly, MRI image artifacts caused by such devices are not considered safety hazards and therefore are not covered by this standard.

Key Topics

• Scope and Purpose
  IEC 62570 specifies how to mark medical and other devices that may be introduced into MR environments. It applies to devices used within the spatial reach of the MR magnetic field including static magnetic fields, gradient fields, and radiofrequency fields.

• Marking Requirements
  The standard mandates permanent markings using standard terms such as:

  • MR Safe – indicating no known hazards in MR environment
  • MR Conditional – indicating safety only under specified conditions
  • MR Unsafe – indicating known hazards in the MR environment
    These terms are supplemented by symbols and additional safety information describing the conditions under which the device may be used safely.

• Assessment of Hazards
  The standard refers to evaluating potential magnetically induced displacement forces, torques, and RF-induced heating to determine appropriate MR classification. These assessments are critical for ensuring device safety and usability within varying strengths and configurations of MRI machines.

• Terminology
  Clear definitions are provided for terms such as magnetically induced displacement force, hazard, MR environment, and items that might interact with MR equipment. This promotes consistent understanding among manufacturers, users, and regulatory bodies.

• Safety Communication
  IEC 62570 highlights the importance of clear labeling to convey risk information, ensuring that users are aware of any required restrictions or conditions such as maximum magnetic field strength, SAR limits, and device configurations.

Applications

• Medical Device Manufacturing
  Manufacturers utilize IEC 62570 to label devices intended for use near MRI scanners, such as implants, tools, monitors, and accessories, ensuring adherence to international safety standards.

• Hospital and Clinical Settings
  Healthcare professionals rely on devices marked according to IEC 62570 to prevent accidents or malfunctions triggered by the powerful MR magnetic fields, thereby safeguarding patients and staff.

• Regulatory Compliance
  Marking practices outlined in the standard help meet regulatory requirements globally, facilitating market access and improving device traceability regarding MR safety.

• Risk Management
  Organizations implement IEC 62570 markings as part of broader risk mitigation strategies when integrating new devices into MR environments, protecting against unintended electromagnetic interactions.

Related Standards

IEC 62570 references and complements several related standards to create a comprehensive safety framework:

• ASTM F2052 – Measurement of magnetically induced displacement forces
• ASTM F2119 – Evaluation of MR image artifacts from passive implants
• ASTM F2182 – Measurement of RF-induced heating on or near passive implants
• ASTM F2213 – Measurement of magnetically induced torque on devices
• IEC 60601-2-33 – Particular requirements for safety of MR equipment for medical diagnosis
• ISO 14971 – Application of risk management to medical devices
• ISO/IEC Guide 51 – Guidelines on safety aspects inclusion in standards
• ISO TS 10974 – Assessment of MR safety for active implantable medical devices

These interconnected standards collectively ensure comprehensive safety, performance, and risk evaluation for medical devices used in MR environments.

---

Keywords: MR safety, medical device marking, IEC 62570, magnetic resonance environment, MRI safety standards, MR conditional, MR safe, MR unsafe, medical device labeling, magnetically induced torque, RF-induced heating, magnetic displacement force, diagnostic imaging equipment.

Standards Content (Sample)

IEC 62570 ®
Edition 1.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Standard practice for marking medical devices and other items for safety in the
magnetic resonance environment

Pratiques normalisées relatives au marquage des appareils médicaux et des
éléments de sûreté divers dédiés aux environnements de résonance magnétique

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IEC 62570 ®
Edition 1.0 2014-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Standard practice for marking medical devices and other items for safety in the

magnetic resonance environment

Pratiques normalisées relatives au marquage des appareils médicaux et des

éléments de sûreté divers dédiés aux environnements de résonance

magnétique
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX Q
ICS 11.040.50; 11.040.55 ISBN 978-2-8322-1443-5

CONTENTS
FOREWORD . 3
1 Scope . 5
2 Referenced Documents . 5
3 Terminology . 6
4 Significance and Use . 7
5 Requirements for assessment of potential hazards caused by interactions of an item
and the MR Environment . 7
6 Methods of Marking. 7
7 Information Included in MR Marking . 8
8 Keywords . 10
APPENDIX . 13
X1. RATIONALE . 13

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER
ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT

FOREWORD
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International Standard IEC 62570, integrating the unmodified text of ASTM F2503 - 13, has been
developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62:
Medical equipment in medical practice, in collaboration with ASTM.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/933/FDIS 62B/934/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
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IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

F2503 - 13
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 - 13; 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 (ε) indicates an editorial change since the last revision or
reapproval.
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 his standard to establish appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
2. Referenced Documents
2.1 The following referenced documents are indispensable for the application of this document. For
dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
2.2 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
2.3 Other Standards:
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic
Resonance Equipment for Medical Diagnosis
ISO 14971 Medical Devices — Application of Risk Management to Medical Devices

ISO/IEC Guide 51 Safety Aspects — Guidelines for their Inclusion in Standards
ISO TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable
Medical Device
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct
responsibility of Subcommittee F04.15 on Material Test Methods.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2005. Last previous edition approved in 2005 as
F2503 – 05. DOI: 10.1520/F2503 - 08.
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.
F2503 - 13
3. Terminology
3.1 Definitions:
3.1.1 harmful interaction— unintended direct or indirect interaction of items with MR equipment,
especially with the static magnetic field, the gradient fields and the RF fields of the MR equipment, that
can pose hazards to patients or other persons.
NOTE 1- In this context, the affected image quality or image artifacts are not considered to be a harmful
interaction.
3.1.2 hazard—potential source of harm. [ISO/IEC Guide 51]
3.1.3 item—object that might be brought into the MR environment.
3.1.4 magnetically induced displacement force—force produced when a magnetic object is exposed to the spatial
gradient of a static magnetic field. This force will tend to cause the object to translate in the spatial gradient of the
static magnetic field.
3.1.5 magnetically induced torque—torque produced when a magnetic object is exposed to a magnetic field. This
torque will tend to cause the object to align itself along the magnetic field in an equilibrium direction that induces no
torque.
3.1.6 magnetic induction or magnetic flux density (B in T)—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force experienced by an element of electric current at the point,
or by the electromotive force induced in an elementary loop during any change in flux linkages with the loop at the
point. The magnetic induction is frequently referred to as the magnetic field. B is the static field in an MR
equipment and accessories. Plain type indicates a scalar (for example, B) and bold type indicates a vector (for
example, B).
3.1.7 magnetic resonance (MR)—resonant absorption of electromagnetic energy by an ensemble of
atomic nuclei situated in a magnetic field. IEC 60601-2-33, definition 201.3.217
3.1.8 magnetic resonance (MR) equipment—medical electrical equipment which is intended for in vivo
magnetic resonance examination of a patient comprising all parts in hardware and software from the
supply mains to the display monitor.
NOTE 2- The MR equipment is a programmable electrical medical system (PEMS) IEC 60601-2-33,
definition 201.3.218
3.1.9 magnetic resonance (MR) examination—process of acquiring data by magnetic resonance from a
patient IEC 60601-2-33, definition 201.3.219
3.1.10 magnetic resonance (MR) environment—the three dimensional volume of space surrounding the MR
magnet that contains both the Faraday shielded volume and the 0.50 mT field contour (5 gauss (G) line). This
volume is the region in which an item might pose a hazard from exposure to the electromagnetic fields produced by
the MR equipment and accessories.
3.1.11 MR Conditional–an item with demonstrated safety in the MR environment within defined conditions. At a
minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the
radiofrequency fields. Additional conditions, including specific configurations of the item, may be required.
3.1.12 Supplementary Marking—additional information that, in association with a marking as “MR Conditional,”
states via additional language the conditions in which an item can be used safely within the MR environment.
3.1.13 MR Safe—an item that poses no known hazards resulting from exposure to any MR environment. MR
Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic
Note 3- An item composed entirely of electrically nonconductive, nonmetallic and nonmagnetic materials may be
determined to be MR Safe by providing a scientifically based rationale rather than test data. Examples of MR Safe items are
a cotton blanket or a silicone catheter.
3.1.14 MR Unsafe—an item which poses unacceptable risks to the patient, medical staff or other persons within
the MR environment.
NOTE 4— ISO 14971 Medical devices - Application of risk management to medical devices, includes a process for evaluating
risks, including identifying unacceptable risks. MR Unsafe items include items such as a pair of ferromagnetic scissors.
3.1.15 medical device—any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or
calibrator, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific purpose(s) of:
(1) diagnosis, prevention, monitoring, treatment, or alleviation of disease;
(2) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
(3) investigation, replacement, modification, or support of the anatomy or of a physiological process;
F2503 - 13
(4) supporting or sustaining life;
(5) control of conception;
(6) disinfection of medical devices;
(7) providing information for medical purposes by means of in vitro examination of specimens derived from the
human body, and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological, or metabolic means, but which may be assisted in its function by such means. [ISO 13485]
3.1.16 radio frequency (RF) magnetic field—the magnetic field in MRI that is used to flip the magnetic moments.
The frequency of the RF field is γB where γ is the gyromagnetic constant, 42.56 MHz/T for protons, and B is the
0 0
static magnetic field in Tesla.
3.1.17 safety—freedom from unacceptable risk.
3.1.18 specific absorption rate (SAR)—radio frequency power absorbed per unit of mass (W/kg). [IEC
60601-2-33]
3.1.19 tesla, (T)—the SI unit of magnetic induction equal to 10 gauss (G).
4. 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 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.
5. Requirements for assessment of potential hazards caused by interactions of an item and the MR
Environment
5.1 Perform testing sufficient to characterize the behavior of the item in the MR environment.
5.1.1 In particular, testing for items that may be placed in the MR environment should address magnetically
induced displacement force (Test Method F2052), magnetically induced torque (Test Method F2213), and RF
heating (Test Method F2182 for passive implants and ISO TS 10974 for active implants).  Additionally, electronic
components shall be evaluated for malfunction.
5.1.2 Other possible safety issues to consider for the hazard assessment include, but are not limited to, thermal
injury, induced currents/voltages, interaction with the switched gradient field, dB/dt, for all items that may go inside
the magnet bore, electromagnetic compatibility, neurostimulation, acoustic noise, interaction among devices, and the
malfunction of the item and the malfunction of the MR equipment and accessories. See Table X.1.1 for some
hazards and associated test methods. Also see Section X1.2.1.4.
5.2 List any parameter that affects the safety of the item. Describe any condition that is known to produce an
unsafe condition.
NOTE 5 - These remarks do not claim to be complete. Therefore it is recommended that the user of this standard consider specific questions and
topics that may be applicable to the specific item being evaluated. Some potential hazards to patients and others in the MR environment are given
in X1.2.1 and Table X1.1.
6. Methods of Marking
6.1 The marking method shall not compromise performance or function of the marked item and should provide
legibility over the anticipated service life of the item. 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 the conditions for safety
in the MR environment.
F2503 - 13
7. Information Included in MR Marking
7.1 Medical devices and other items vary widely in size, and the amount of information that practically can be
included in marking varies accordingly.  For implants, the MR marking shall be included in the labeling (including
the instructions for use, package inserts, patient and physician manuals) and on the patient information card. Non-
implanted items, where feasible, shall have MR marking on the item as well as in the labeling. Some items (for
example, small or very thin ones) do not provide any surfaces which can be marked practically. For items for which
direct marking is not practical, the MR marking shall be included in the labeling. For both implants and non-
implanted items, the MR marking may be placed on the product packaging label (e.g. on the box), however the
package label should clearly indicate the item(s) inside the packaging to which the MR marking applies (e.g.,
implant only or implant and delivery system).

7.2 The marking method shall not compromise performance or function of the marked item and should remain
readable over the anticipated service life of the item.
7.3 Minimum Information—As a result of the testing described in Section 5, mark the item as MR Safe, MR
Conditional, or MR Unsafe using the icons as shown in Tables 1 and 2.
7.3.1 The MR Safe icon consists of the letters “MR” surrounded by a green square (Table 1 and Figures 1 and 2).
Two options are given. When color reproduction is not practical, the icon may be printed in black and white (Table 2
and Figures 3 and 4). The use of the colored icon is strongly encouraged for the added visibility and information
provided by the color. For both color and black and white options in Tables 1 and 2, the option that is most visible
for the individual application should be chosen.
7.3.2 The MR Conditional icon consists of the letters “MR” within a yellow equilateral triangle with a thick black
band around the perimeter (Table 1 and Figure 5). The triangle is oriented with its horizontal side below the letters
“MR.” When color reproduction is not practical, the icon may be printed in black and white (Table 2 and Figure 6).
The use of the colored icon is strongly encouraged for the added visibility and information provided by the color.
7.3.2.1 For MR Conditional items, the item labeling (instructions for use, package inserts, operator manual,
patient information card, patient and physician information pamphlets, as appropriate) shall include appropriate
information from Section 5. (1) The MR Conditional icon may be supplemented by supplementary marking which
includes the appropriate information from Section 5 and describes the conditions for which the item has been
demonstrated to be MR Conditional. The supplementary marking consists of text surrounded by a rectangular frame
(Figure 7).
7.3.2.2 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.
NOTE 6— This marking may be particularly useful for inclusion on nonimplanted items that are used in the MR environment,
for instance on electronic equipment, room furnishings, or item packaging and labeling.
Note 7– This marking may also be used if one portion of a kit or device with accessories is MR Conditional. For example,
indicate “stent only” for a system that consists of stent plus delivery catheter.
7.3.3 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 quadrant of the circle and oriented at 45°
from the horizontal (Table 1 and Figure 8). When color reproduction is not practical, the icon may be printed in
black and white (Table 2 and Figure 9). The use of the colored icon is strongly encouraged for the added visibility
and information provided by the color.

7.4 The icons shall comply with the layout requirements given below. The colors are given in Table 3. Note that
the colors represented in an electronic or paper copy of this document may not match the colors as defined in Table
3.
7.4.1 MR Safe icon, Color Option 1 (Figure 1):
7.4.1.1 The colors of the MR Safe icon shall be as follows for option 1:
(1) Background color: green
(2) Letters ‘MR’: white
(3) The letters ‘MR’ shall be capitalized, in Arial font and centered in the square. The letters shall be sized as
large as possible to be contained within the green square, but not touching the border of the square.

7.4.2 MR Safe icon, Color Option 2 (Figure 2):
7.4.2.1 The colors of the MR Safe icon shall be as follows for option 2:
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(1) Background color: white
(2) Letters ‘MR’: green
(3) Frame: green. The width of the frame shall be approximately 10% of the length of a side of the square.
(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.

7.4.3 MR Safe icon, Black and White Option 1(Figure 3):
7.4.3.1 For option 1 of the black and white version of the MR Safe icon, the colors shall be as follows:
(1) Background color: black
(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.

7.4.4 MR Safe icon, Black and White Option 2(Figure 4):
7.4.4.1 For option 2 of the black and white version of the MR Safe icon, the colors shall be as follows:
(1) Background color: white
(2) Letters ‘MR’: black
(3) Frame: black. The width of the border shall be approximately 10% of the side length of the square.
(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.

7.4.5 MR Conditional Icon, Color Option (Figure 5):
7.4.5.1 The colors of the MR Conditional icon shall be as follows:
(1) Background color: yellow
(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.
7.4.6 MR Conditional Icon, Black and White Option (Figure 6)
7.4.6.1 For the black and white version of the MR Conditional icon, the colors of the icon shall be as follows:
(1) Background color: white
(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.
7.4.7 Supplementary marking for MR Conditional Items, Color Option (Figure 7):
7.4.7.1 For the color option of the MR Conditional Supplementary marking, colors shall be as follows:
(1) Background color: yellow
(2) Rectangular Frame: black
(3) Text: black
(4) The safety color yellow shall cover at least 50 % of the total area of the icon.
(5) The text shall be in Arial font.

7.4.8 Supplementary marking for MR Conditional Items, Black and White Option (Figure 7):
7.4.8.1 For the black and white option of the MR Conditional Supplementary marking, the colors shall be as
follows:
(1) Background color: white
(2) Rectangular Frame: black
(3) Text: black
(4) The text shall be in Arial font.

7.4.9 MR Unsafe Icon, Color option (Figure 8):
7.4.9.1 The colors of the MR Unsafe icon shall be as follows:
(1) Background color: white
(2) Circular frame and diagonal bar: red
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(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.
7.4.10 MR Unsafe Icon, black and white option (Figure 9):
7.4.10.1 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
(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.
8. Keywords
8.1 magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR
safety
TABLE 1 Requirements for Colored MR Icons

Icon Geometric Shape and Appearance Meaning
A square MR Safe
or
An equilateral triangle with radiused outer corners MR Conditional

A circle with a diagonal bar MR Unsafe

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TABLE 2 Requirements for Black and White MR Icons

Icon Geometric Shape and Appearance Meaning
A square MR Safe
or
An equilateral triangle with radiused outer corners MR Conditional

A circle with a diagonal bar MR Unsafe

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 standard may be purchased from the ANSI, (212) 642–4900, http://webstore.ansi.org.

FIG. 1 Color Option 1
FIG. 2 Color Option 2
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FIG. 3 Black and White Option 1

FIG. 4 Black and White Option 2

FIG. 5 MR Conditional Icon Geometry, Color Option

FIG. 6 MR Conditional Icon Geometry, Black and White Option

FIG. 7 Supplementary Marking for MR Conditional Items

FIG. 8 MR Unsafe, Color Option

FIG. 9 MR Unsafe, Black and White Option

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APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 The intent of this practice is to provide needed information about the safety of items in and near MR
scanners using a compact and easily recognized set of icons and terms. The terms MR safe and MR compatible as
first defined in 1997 in the FDA draft guidance document, “A Primer on Medical Device Interactions with Magnetic
Resonance Imaging Systems,” were used to describe the safety of devices in and near MR equipment and
accessories. The historical definitions are:

MR Safe The device, when used in the MR environment, has been demonstrated to present no additional
(outdated risk to the patient or other individuals, but may affect the quality of the diagnostic information.
definition) The MR conditions in which the device was tested should be specified in conjunction with the
terms MR safe and MR compatible since a device that is safe or compatible under one set of
conditions may not be found to be so under more extreme MR conditions.
MR The device, when used in the MR environment, is MR safe and has been demonstrated to neither
Compatible significantly affect the quality of the diagnostic information nor have its operations affected by the
(obsolete MR device. The MR conditions in which the device was tested should be specified in conjunction
definition) with the terms MR safe and MR compatible since a device that is safe or compatible under one set
of conditions may not be found to be so under more extreme MR conditions.

There was a great deal of confusion surrounding this terminology. An incorrect assumption was often made. Users
often incorrectly assumed that items labeled MR safe or MR compatible were safe or compatible for any MR
environment. MR environments vary in terms of magnetic field strength and RF conditions. Therefore, an item tested
under one set of conditions may be affected differently by the conditions in another MR environment. In addition,
some devices labeled MR safe and MR compatible using the historical definitions in X1.1 have gauss line
restrictions or RF pulse sequence limitations that must be adhered to in order to safely use the device in the MR
environment. In short, using the historical definitions it was impossible to definitively establish a device as MR safe
or MR compatible without also specifying the conditions under which the device was tested. The current terms in
this practice (MR Safe, MR Unsafe, and MR Conditional, Section 3) assist in clearing up this confusion.
NOTE X1.1—This revised terminology has not yet been applied to all medical devices tested before the approval of Practice
F2503. Therefore, there are items that still contain the prior terminology (that is, use the old terms MR safe and MR compatible)
in their labeling.
Note X1.2 IEC 60601-2-33 ed.3 201.7.9.3.101b provides a compatibility technical specification sheet containing parameters
that describe the MR equipment. The specification sheet is part of the MR equipment user manual and can be used to assess MR
Conditional requirements.
X1.2 Although a commercial 1.5 T MR system currently produces the conditions that are most commonly
encountered, 3 T and higher strength MR systems are becoming more common in clinical situations. It is important
to note that an item that can be marked MR Conditional in a 1.5 T scanner may not be safe in systems with higher or
lower field strength. Also, there can be major differences in the characteristics of open and cylindrical MR systems.
For instance, the spatial gradient of the static magnetic fields may be significantly higher in open systems.
Depending on the design of the magnet, the direction and magnitude of the static magnetic field and the spatial
gradient of the static magnetic field can vary significantly from system to system.
X1.2.1 A brief list of potential risks and hazards that have been observed include:
X1.2.1.1 Magnetically induced displacement force, both static and dynamic, that acts to pull magnetic items into
the bore of the MR equipment.
(1) This force is applicable to all ferromagnetic, paramagnetic, and diamagnetic materials (including all
metals).
(2) Magnetically induced displacement force depends on
(a) the static magnetic field B ,
(b) the spatial gradient of the static magnetic field, and
(c) the magnetic saturation of the device material.
Dynamic magnetically induced force depends on the speed of the movement, the magnitude of the spatial
gradient of the static magnetic field, the effective area of introduction, and the conductivity of the device material.
Also see ASTM F2052 for more information on static magnetically induced force.
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X1.2.1.2 Magnetically induced torque, both static and dynamic, that rotates magnetic objects to align them with
the MR system magnetic field (as a compass needle is aligned with the Earth’s magnetic field).
(1) This torque is applicable to all ferromagnetic, paramagnetic, and diamagnetic materials (including all
metals).
(2) Magnetically induced torque depends on
(a) the static magnetic field B ,
(b) the device dimensions and geometry, and
(c) the magnetic saturation of the device material.
Dynamic magnetically induced torque depends on the speed of the movement, the magnitude of the spatial
gradient magnetic field, the effective area of introduction, and the conductivity of the device material. Also see
ASTM F2213 for more information on static magnetically induced torque.
X1.2.1.3 Radiofrequency (RF) induced heating of objects inside the MRI bore.
(1) RF induced heating may occur with any electrically conductive item.
(2) RF induced heating depends on
(a) the electrical conductivity and permittivity of the device (impedance of electronic device
parts),
(b) the geometric dimension of the device and configuration,
(c) the surrounding tissue conductivity and permittivity,
(d) the energy of the RF pulses (SAR), induced E field, B1 field,
(e) the geometric arrangement relative to RF transmit coil,
(f) the patient body relative to RF transmit coil,
(g) the specific MR coil electromagnetic field characteristics, and
(h) the center frequency of the specific MR system.
Also see ASTM F2182 for passive implants and ISO TS 10974 for active implants for more information.
X1.2.1.4 Gradient induced voltages resulting in patient stimulation, or item activation, deactivation, or damage,
heating, and vibration.
(1) Gradient induced interactions depend on
(a) the gradient amplitude (x,y,z) expressed in mT/m (milliTesla/meter)
(b) the effective stimulation time of the gradient pulse, the combination of these two
parameters resulting in the gradient slew rate expressed in T/m/s
(c) the device position within the gradient coil, and
(d) the device orientation within the gradient coil, the effective areas of induction, the
conductivity of the device materials, and the static magnetic field B. Also see ISO TS
10974 for more information.
X1.2.1.5 Item malfunction.
(1) Item malfunction depends on
(a) the static magnetic field,
(b) the switched gradient magnetic field,
(c) the RF electromagnetic field, and
(d) parameters such as the device configuration, orientation, and operational status (on, off,
standby, or other).
Item malfunction will be highly dependent on the item. Malfunctions may cause false information to be
presented on or to an electrically active item or an electromechanical item caused by the MR equipment’s
magnetic or radiofrequency fields. Also see ISO TS 10974, Assessment of the safety of magnetic resonance
imaging for patients with an active implantable medical device, for more information.
X1.2.1.6 Other risks exist.
(1) Other risks exist and a review of the available clinical literature is recommended to determine the
appropriate MR safety marking for the device or item. Evaluation of medical devices for these risks
and hazards generally involves a combination of testing and modeling. IEC 62464-1 "Magnetic
Resonance Equipment for Medical Imaging - Part 1: Determination of essential image quality
parameters" contains test methods to determine the signal noise ratio, image uniformity, image slice
thickness, two dimensional geometrical distortion, spatial resolution, and ghosting artifacts.
(2) Examples of risk identification based on item components follows. These are not considered to be
compr
...