prEN IEC 62570:2025
(Main)Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
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
Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov za varno uporabo v okolju magnetne resonance
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2025
Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov
za varno uporabo v okolju magnetne resonance
Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
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
Ta slovenski standard je istoveten z: prEN 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.
62B/1381/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 62570 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-04-11 2025-07-04
SUPERSEDES DOCUMENTS:
62B/1379/RR
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62C
ASPECTS CONCERNED:
Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which t hey
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Standard practice for marking medical devices and other items for safety in the magnetic resonance
environment
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
Please refer to 62B/1371/Q, 62B/1374/RQ, 62B/1379/RR
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
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 service@astm.org. 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
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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
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
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