EN IEC 62570:2025

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

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. This document 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. 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.

Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen

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

L'IEC 62570:2025 s'applique aux appareils médicaux et éléments divers qui sont présumés entrer dans l'environnement de résonance magnétique (RM). Ce document spécifie le marquage des éléments présumés entrer dans l'environnement de RM à l'aide de termes et d'icônes, et recommande les informations qu'il convient d'intégrer à l'étiquetage. Les artefacts d'image à RM ne relèvent pas du domaine d'application des parties obligatoires de cette pratique, car ils ne constituent pas un problème de sécurité résultant directement des caractéristiques spécifiques de l'examen par RM.

Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov za varno uporabo v okolju magnetne resonance (IEC 62570:2025)

General Information

• Status: Published
• Publication Date: 27-Nov-2025
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 28-Nov-2025
• Due Date: 31-Dec-2025
• Completion Date: 28-Nov-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 62570:2026 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2025)

Relations

• Replaces: EN 62570:2015 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
• Effective Date: 04-Mar-2025

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2026
Nadomešča:
SIST EN 62570:2015
Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov
za varno uporabo v okolju magnetne resonance (IEC 62570:2025)
Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment (IEC 62570:2025)
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer
Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen (IEC
62570:2025)
Pratiques normalisées relatives au marquage des appareils médicaux et des éléments
de sûreté divers dédiés aux environnements de résonance magnétique (IEC
62570:2025)
Ta slovenski standard je istoveten z: EN IEC 62570:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 62570

NORME EUROPÉENNE
EUROPÄISCHE NORM November 2025
ICS 11.040.50; 11.040.55 Supersedes EN 62570:2015
English Version
Standard practice for marking medical devices and other items
for safety in the magnetic resonance environment
(IEC 62570:2025)
Pratiques normalisées relatives au marquage des appareils Standardverfahren für die Kennzeichnung medizinischer
médicaux et des éléments de sûreté divers dédiés aux Geräte und anderer Gegenstände zur Sicherheit in der
environnements de résonance magnétique Umgebung von Magnetresonanzeinrichtungen
(IEC 62570:2025) (IEC 62570:2025)
This European Standard was approved by CENELEC on 2025-10-23. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62570:2025 E
European foreword
The text of document 62B/1381/CDV, future edition 2 of IEC 62570, prepared by SC 62B "Medical
imaging equipment, software, and systems" of IEC/TC 62 "Medical equipment, software, and systems"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-11-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-11-30
document have to be withdrawn
This document supersedes EN 62570:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 62570:2025 was approved by CENELEC as a European
Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
ASTM F2052 - Standard Test Method for Measurement of - -
Magnetically Induced Displacement Force
on Medical Devices in the Magnetic
Resonance Environment
ASTM F2119 - Standard Test Method for Evaluation of - -
MR Image Artifacts from Passive Implants
ASTM F2182 - Standard Test Method for Measurement of - -
Radio Frequency Induced Heating Near
Passive Implants During Magnetic
Resonance Imaging
ASTM F2213 - Standard Test Method for Measurement of - -
Magnetically Induced Torque on Medical
Devices in the Magnetic Resonance
Environment
IEC 60601-2-33 - Medical electrical equipment - Part 2-33: EN IEC 60601-2-33 -
Particular requirements for the basic safety
and essential performance of magnetic
resonance equipment for medical
diagnosis
ISO 14971 - Medical devices - Application of risk EN ISO 14971 -
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

IEC 62570 ®
Edition 2.0 2025-09
INTERNATIONAL
STANDARD
Standard practice for marking medical devices and other items for safety in the
magnetic resonance environment

ICS 11.040.50; 11.040.55 ISBN 978-2-8327-0717-3

IEC 62570:2025-09(en)
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CONTENTS
Foreword . 2
1 Scope . 4
2 Referenced documents . 4
3 Terminology . 4
4 Significance and use . 5
5 Hazards pertaining to items entering the MR environment . 6
6 MR marking . 6
7 Keywords . 9
Appendix. 9
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Standard practice for marking medical devices and other items for safety
in the magnetic resonance environment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 62570 has been prepared by subcommittee 62B: Medical imaging equipment, software,
and systems, of IEC technical committee 62: Medical equipment, software, and systems. It is
an International Standard.
It is based on ASTM F2503-23 and was submitted as a Fast-Track document.
The text of this International Standard is based on the following documents:
Draft Report on voting
%//&'9 %//RV&
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
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The structure and editorial rules used in this publication reflect the practice of the organization
which submitted it.
This document was developed in accordance with ISO/IEC Directives, Part 1 and ISO/IEC
Directives, IEC Supplement, available at www.iec.ch/members_experts/refdocs. The main
document types developed by IEC are described in greater detail at www.iec.ch/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
x reconfirmed,
x withdrawn, or
x revised.
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.
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´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- 5
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 2
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 ofASTM 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.

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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 0
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
Conditional, or MR Unsafe using the icons as shown in Tables
5.1 For items entering the MR environment that could
1 and 2.
interact with the static magnetic field associated with an MR
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
options are given. When color reproduction is not practical, the
applicable, force, torque, and malfunction.
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.
6.4.2.1 The colors of the MR Safe icon shall be as follows
NOTE 4—This supplementary marking of information for safe usage
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, Munse
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